ExiStation System 3. AccuPower Real-Time PCR Diagnostic Kits 7. ExiPrep Dx Nucleic Acid Extraction Kits 43. Ordering Information 49

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2 A B C D ExiStation System 3 7 B-1. Human Immunodeficiency Virus B-2. Hepatitis Virus B-3. BCI Blood Screening B-4. Mycobacterium Tuberculosis B-5. Sexually Transmitted Infections B-6. Transplantation related Virus B-7. Human Papillomavirus B-8. Respiratory Pathogens B-9. Gastrointestinal Pathogens B-10. Human Genotyping B-11. Chronic Myelogenous Leukemia (CML) B-12. Mosquito-borne Diseases (ZIKV, DENV and CHIKV) ExiPrep Dx Nucleic Acid Extraction Kits 43 C-1. Viral DNA/RNA Kit C-2. Blood Viral DNA Kit C-3. Bacteria Genomic DNA Kit C-4. Genomic DNA Kit C-5. Blood Genomic DNA Kit Ordering Information 49

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4 ExiStation System ExiStation Universal Molecular Diagnostic System ExiStation Series is a molecular diagnostic platform for various scales of laboratories. This series is composed with ExiStation, ExiStation 48, ExiStation 48 A and ExiStation HT. All ExiStation system have a several common advantages. Able to detect tiny copies of viruses in samples owing to built-in quality control system Easy process of diagnosis by using pre-installed protocol Simultaneous PCR for various target since all AccuPower kits were optimized to same thermal cycle condition using Exicycler 96 Streamlined workflow using user-friendly ExiStation Manager software from sample preparation to data analysis ExiStation Able to handle up to 48 samples with combination of 3 ExiPrep 16 Dx and 1 Exicycler 96 Available for simultaneous diagnosis of various diseases : For example HIV, STI and TB can be detected simultaneously as ExiPrep 16 Dx can extract nucleic acid from different specimen at the same time ExiStation 48 / ExiStation 48 A Nucleic acid extraction from 48 samples within an hour. Enhanced usability with built in automatic cartridge puncher and various option of sample volume, 400 and 800 ul Use primary tube directly: all process is automated such as decapping/capping of sample tube and sample transfer* Input sample information automatically by using built-in barcoding system* * Only apply to ExiStation 48 A (In development) ExiStation HT All equipments necessary for diagnosis, from nucleic acids extraction to Real-Time PCR, are pre-installed Fully automatic system allows real high through-put for up to 9 hours of walk-away time Minimized handling step by Sample-in, Data out operation Up to 5 different types of specimen can be used in a single loading Able to handle Max. 480 samples in a loading (5 decks) BIONEER 4

5 ExiStation System Configuration Sample Transfer Nucleic acid extraction Real-Time PCR ExiLT BT ExiPrep 16 Dx ExiPrep 48 Dx Exicycler 96 ExiStation ExiStation 48 ExiStation 48 A ExiStation HT Built-in equipment for all process from NA extraction and Real-Time PCR Workflow Through put ExiStation (with 1 Exiprep 16 Dx) ExiStation (with 2 Exiprep 16 Dx) ExiStation (with 3 Exiprep 16 Dx) Max. No. of test / a day (based on 9-hour workday) Hands on time (for Extraction) Extraction Hands on time (for PCR) PCR Analysis 48 tests 15 min 1 hr 30 min 15 min 1 hr 20 min 96 tests 30 min 1 hr 30 min 15 min 1 hr 20 min 144 tests 45 min 1 hr 30 min 15 min 1 hr 20 min ExiStation tests 35 min 1 hr 15 min 1 hr 20 min ExiStation 48A 192 tests 5 min 1hr 20 min 15 min 1 hr 20 min ExiStation HT 480 tests 1 hr First 96 samples (1 Deck) : 3 hours Subsequent samples in 96 batch : 1.5 hours 5

6 ExiStation System Components ExiPrep 16 Dx Fully Automated Nucleic Acid Extraction System Random-access system Simultaneous nucleic acid extraction from various types of clinical samples - Each of 3 ExiPrep 16 Dx extracts different targets at once 5 different contamination prevention measures Handle Max. 48 samples in 90 min - Each ExiPrep 16 Dx handles 16 samples in 90 min ExiPrep 48 Dx Enhanced usability with built in automatic cartridge puncher Various option of sample volume: 100, 400 and 800 ul Able to use primary tube by docking ExiLT Handle Max 48 samples in an hour Exicycler 96 Real-Time Quantitative Thermal Block Superior sensitive optics by light polarization, which remove a reflection light, allowing precise quantification and target Improved thermal block ramping rate - Reduced run time by 25% (Max. 96 samples in 90 min) - Two types: Normal block (Max 4.5 C/sec), Fast block (Max 5.0 C /sec) 5 channel multiplex detection without use of a reference dye ExiSpin Fully automated spin-mix-spin centrifuge Programmable protocol ensures reproducible results ExiStation system includes 1 ExiSpin ; ExiStation 48 system includes 2 ExiSpin ExiStation Manager software Control the entire ExiStation MDx System from sample preparation to data analysis Automatic analysis of different target results for individual samples with LIS connection Ordering Information BIONEER Cat. no. Kit name Target A-2060 Exicycler 96 Real-Time Quantitative Thermal Block 96 A-5050 ExiPrep 16 Dx Fully Automated Nucleic Acid Extraction System 16 A-5150 ExiPrep 48 Dx 48 A-7040 ExiSpin 32 6

7 8 B-1. Human Immunodeficiency Virus 10 B-2. Hepatitis Virus 11 B-3. BCI Blood Screening 13 B-4. Mycobacterium Tuberculosis 14 B-5. Sexually Transmitted Infections 16 B-6. Transplantation related Virus 20 B-7. Human Papillomavirus 23 B-8. Respiratory Pathogens 25 B-9. Gastrointestinal Pathogens 29 B-10. Human Genotyping 31 B-11. Chronic Myelogenous Leukemia (CML) 39 B-12. Mosquito-borne Diseases (ZIKV, DENV and CHIKV) 40 * References 41

8 are vacuum-dried qpcr and RT-qPCR premixes. All the components necessary for Real-Time PCR are contained within one tube, which increases the stability of reagents and simplifies reaction setup. Due to this simplified setup, AccuPower technology is ideal for automated molecular diagnostics. Furthermore, use proprietary stabilization technology that preserves the full activity of the mixed reagents, and patented HotStart technology (US ) that enhances sensitivity and specificity of the kits. Features Signature Convenience All components for the assay are contained within a tube Outstanding Stability and Reproducibility Vacuum-dried Premix suspends reagent deterioration and reduces user error Optimized for Sensitive and Robust Performance Eliminate non-specific DNA amplification by utilizing a proprietary HotStart method Reliable Results Internal Positive Control (IPC) in each premix tube monitors each assay PCR performance and for possible inhibition Components of the kit Just add sample! - Real-Time PCR Premix (Including Reaction Buffer, Enzyme, Target Primer/Probe set, Internal Positive Control Primer/Probe set, dntps Stabilizer) - Control DNA/RNA (Standard DNA/RNA, Positive Control DNA/RNA, Internal Positive Control DNA/RNA) - DEPC D.W., Optical Sealing Film, Quick Manual BIONEER 8

9 Dual-HotStart Technology The most important aspects in diagnosis are specificity and sensitivity, which decide accuracy of diagnosis. Since accurate diagnosis will lead to proper treatment. In other words, it is directly related to patient s health and even lives. Dual-HotStart technology is unique diagnostic technology developed by Bioneer in order to enhance quality and save millions of lives. This technology is a method to detect RNA target from clinical samples with high sensitivity and specificity. This technology utilizes Bioneer s unique enzyme-mediated HotStart method for both reverse transcription and PCR amplification. Dual-HotStart eliminates non-specific cdna synthesis and non-specific DNA amplification and allows for the most sensitive one-step RT-qPCR assays available. Features Dual-HotStart RT-qPCR reactions is key technology of accurate diagnosis with Pyro-HotStart RT and HotStart PCR Maximize sensitivity by extending the reaction through pyrophosphate cleanup with pyrophosphatase Increase specificity by preventing non-specific zero-cycle product formation Figure 1. Serial dilutions of HCV RNA were amplified by conventional RT-PCR (left panel) and Dual-HotStart RT-PCR (right panel). The results suggest that Dual-HotStart RT-PCR enables highly sensitive detection of low copies of RNA target by eliminating non-specific cdna synthesis and nonspecific PCR amplification. 9

10 B-1. Human Immunodeficiency Virus AccuPower HIV-1 Quantitative RT-PCR Kit Human immunodeficiency virus (HIV) is recognized as a known viral agent that causes Acquired Immune Deficiency Syndrome (AIDS). Thus, monitoring of viral load in HIV-1 infection patients is an essential test for establishment of therapeutic strategy and determination of therapeutic progress. The AccuPower HIV-1 Quantitative RT-PCR Kit is an in vitro diagnostic kit designed for the quantification of HIV-1 RNA in human EDTA-plasma samples through Real-Time polymerase chain reaction (PCR) using ExiStation MDx System. HIV-1111 PCR PreMix (96 rxn), SPCs (S1~S5), PCs (LPC, HPC), NTC, SL buffer, Optical sealing film Target - human immunodeficiency virus type 1 (HIV-1): integrase region of polymerase gene, 5 LTR Sample type - EDTA-plasma Instrument - ExiStation The AccuPower HIV-1 Quantitative RT-PCR Kit provides; Highly sensitive detection of various HIV-1 subtypes including group M (A, B, C, D, AE, F, AG, G, H, and several CRFs), N and O (Table 1) - The limit of detection (LoD) is 33.1 IU/ml (subtype B) - The limit of quantification (LoQ) is 50 IU/ml One-Step Real-Time RT-PCR reaction using RocketScript Reverse Transcriptase and Dual-HotStart technology High reliability through Internal Positive Control and Low/High Positive Controls Simultaneous combination IVD test with Bioneer s TB and STIs series kits by ExiStation Manager software Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower HIV-1 Quantitative RT-PCR Kit. Black signal; HIV-1, Blue signal; IPC Figure2. Regression analysis between AccuPower HIV-1 Quantitative RT-PCR Kit and CE-IVD approved HIV-1 NAT assay. (R2= 0.96 (p<0.001)) Group M Group O Group N LoD (IU/ml) B 33.1 A C 35 CRF AG D F G 40 CRF AE H Detected Table 1. Group M subtype, group O and N LoD of AccuPower HIV-1 Quantitative RT-PCR Kit BIONEER 10 Cat. no. Kit name Target Tests MTN-1111 AccuPower MTB & NTM Real-Time PCR Kit Mycobacterium tuberculosis, Non-tuberculous mycobacteria 96 STI8A-1111 AccuPower STI8A-Plex Real-Time PCR Kit Chlamydia trachomatis, Neisseria gonorrhoeae, Ureaplasma urealyticum, Mycoplasma 96 genitalium STI8B-1111 AccuPower STI8B-Plex Real-Time PCR Kit Trichomonas vaginalis, Mycoplasma hominis, HSV type 1 and 2 96 K-4471 ExiPrep Dx Viral DNA/RNA Kit 96 K-4473 ExiPrep Dx Viral RNA Kit 96

11 B-2. Hepatitis Virus AccuPower HBV Quantitative PCR Kit Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic liver disease. Hepatitis B is transmitted through blood and infected bodily fluids. Thus, the quantification of hepatitis B virus (HBV) DNA in blood is essential for monitoring of HBV infection. The AccuPower HBV Quantitative PCR Kit is an in vitro diagnostic kit designed for the quantification of HBV DNA in human EDTA-plasma samples through Real-Time PCR using ExiStation MDx System or Exicycler 96. HBV-1111 PCR PreMix (96 rxn), SPCs (S1~S5), HPC, LPC IPC, NTC, SL buffer, DEPC D.W., Optical sealing film Target - Hepatitis B virus: large S protein Sample type - Serum, EDTA-plasma Instrument - ExiStation, Exicycler 96 The AccuPower HBV Quantitative PCR Kit provides; Highly sensitive detection of various HBV genotypes including A, B, C, D, E, F and H (Table 1) - The LoD is 6.02 IU/ml (genotype A2) - The LoQ is 15 IU/ml High performance of repeatability and reproducibility (Table 2) High reliability through Internal Positive Control Specific Real-Time PCR reaction using Enzyme-mediated HotStart technology Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower HBV Quantitative PCR Kit. Black signal; HBV, Blue signal; IPC Genotype LoD(IU/ml) Genotype B C D E F G H EDTA-Plasma Serum Shown 95% detection rate below 5 IU/ml Shown 95% detection rate below 10 IU/ml Table 1. Genotype LoD of AccuPower HBV Quantitative RT-PCR Kit Diagnostic Sensitivity (Percent positive agreement) 100 % (95% C.I ) Figure2. Regression analysis between AccuPower HBV Quantitative RT-PCR Kit and CE-IVD approved HBV viral load NAT assay. (R2= 0.95 (p<0.001)) DiagnosticSpecificity (Percent negative agreement) 100 % (95% C.I ) Table 2. The performance of AccuPower HBV Quantitative PCR Kit was compared to that of CE-IVD approved HBV viral load assay by analysis of paired EDTA plasma specimens from 224 sample in Cerba, France Cat. no. Kit name Target Tests HCV-1111 AccuPower HCV Quantitative RT-PCR Kit Hepatitis C virus 96 K-4471 ExiPrep Dx Viral DNA/RNA Kit 96 K-4472 ExiPrep Dx Viral DNA Kit

12 B-2. Hepatitis Virus AccuPower HCV Quantitative RT-PCR Kit Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). About 80% of those exposed to the virus develop a chronic infection. Guidelines for the management and treatment of HCV recommend quantitative testing for HCV RNA before, during and after the antiviral therapy. The AccuPower HCV Quantitative RT-PCR Kit is an in vitro diagnostic kit designed for the quantification of HCV RNA in clinical samples through Real-Time PCR using ExiStation MDx System. Target - Hepatitis C virus: 5 UTR Sample type - Serum, EDTA-plasma Instrument - ExiStation HCV-1111 PCR PreMix (96 rxn), SPCs (S1~S5), PCs (LPC and HPC), NTC, SL buffer, Optical sealing film The AccuPower HCV Quantitative RT-PCR Kit provides; Clinical Evaluation (Figure 2) Highly sensitive detection of various genotypes of HCV (genotype 1, 2, 3, 4, 5 and 6, Table 1) - The LoD is 10.7 IU/ml (genotype 1a) Diagnostic Sensitivity and Specificity (Table 2) One-Step Real-Time RT-PCR reaction using RocketScript Reverse Transcriptase and Dual-HotStart technology Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower HCV Quantitative RT-PCR Kit. Black signal; HCV, Blue signal; IPC Limit of Dtection (IU/ml) Genotype 1b 2a 2b EDATA-plasma Serum Table 1. Genotype LoD of AccuPower HCV Quantitative PCR Kit Diagnostic Sensitivity (Percent positive agreement) % (95% C.I ) Figure2. Regression analysis between AccuPower HCV Quantitative RT-PCR Kit and CE-IVD approved HCV NAT assay. (R2= 0.95 (p<0.001)) DiagnosticSpecificity (Percent negative agreement) % (95% C.I ) Table 2. The performance of AccuPower HCV Quantitative RT-PCR Kit was compared to that of CE-IVD approved HCV NAT assay by analysis of paired EDTA plasma specimens from 230 samples in Cerba, France. Cat. no. Kit name Target Tests HBV-1111 AccuPower HBV Quantitative PCR Kit Hepatitis B virus 96 HIV-1111 AccuPower HIV-1 Quantitative RT-PCR Kit Human immunodeficiency virus type 1 96 K-4471 ExiPrep Dx Viral DNA/RNA Kit 96 BIONEER K-4473 ExiPrep Dx Viral RNA Kit 96 12

13 B-3. BCI Blood Screening AccuPower BCI Blood Screening Kit The AccuPower BCI Blood Screening Kit is an in vitro diagnostic kit designed for the simultaneous detection of human immunodeficiency virus type 1, type 2 (HIV-1, HIV- 2) RNA, hepatitis C virus (HCV) RNA and hepatitis B virus (HBV) DNA in human blood through Real-Time PCR using ExiStation MDx System. First, the kit is intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor s heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors. Secondly, the assay is not intended for use on cord blood specimens from mothers with recent birth. Third, the assay is intended to use individual samples from living adult donors of whole blood, blood components, plasma, other living donors and heart-beating organ donors, and from individual blood specimens from cadaveric (non-heart-beating) donors. Target - Human immunodeficiency virus type 1, 2, Hepatitis C virus, Hepatitis B virus Sample type - Serum, EDTA-plasma Instrument - ExiStation The AccuPower BCI Blood Screening Kit provides; Distinct detection of each target, HBV, HCV, HIV-1 and HIV-2 by ExiStation MDx System High reliability through Internal Positive Control and Positive Control One-Step Real-Time RT-PCR reaction using RocketScript Reverse Transcriptase and Dual-HotStart technology Figure 1. The test uses 2 wells of NTC and PC to determine the validity of the experiment, and each reaction includes IPC in wells of samples as well as NTC and PC to monitor PCR efficiency. NTC: to determine whether the sample is contaminated in the process of sample pretreatment, nucleic acid extraction, and PCR preparation (prevent false-positive error) PC: to determine whether target DNA is properly amplified (prevent false-negative error) IPC: to check whether PCR is inhibited by the sample and to determine the amplification of nucleic acids in each well. Red signal; HBV, Blue signal; HIV-1/-2, Black signal; HCV, Green signal; IPC Cat. no. Kit name Tests K-4471 ExiPrep Dx Viral DNA/RNA Kit

14 B-4. Mycobacterium Tuberculosis AccuPower TB&MDR Real-Time PCR Kit Multidrug-resistant tuberculosis (MDR-TB) is caused by an organism that is resistant to the two most potent TB drugs: isoniazid (INH) and rifampicin (RIF). These drugs are used to treat all persons with TB disease. However, spontaneous mutations in the Mycobacterium tuberculosis genome can give rise to proteins that make the bacterium drug resistant, depending on the type of drug action. With this, almost 2~3% of new TB patients have MDR-TB, where an effective treatment of TB and MDR-TB, early detection is the top priority. AccuPower TB & MDR Real- Time PCR Kit is an in vitro diagnostic kit designed for the simultaneous detection of M. tuberculosis and MDR-TB DNA extracted from clinical samples. Detectable MDR- TBs are INH and RIF resistant TB. TBMDR-1111 PCR premix (48rxn), TB&MDR PC, IPC, NTC, DEPC D.W., Optical sealing film Target - * RIF : rpob (codon 509, 511, 516, 522, 526, 531, 533), 10 mutant sites, 29 mutations * TB&INH : IS6110(MTB), katg315, inha (INH) 3 mutant sites, 7 mutations Sample type - Sputum, Bronchoalveolar lavage (BAL), Urine Instrument - ExiStation, Exicycler 96 The AccuPower TB&MDR Real-Time PCR Kit provides; Multiplex detection of TB and MDR-TB Simplified procedure of sputum pretreatment with EZ Solution Highly sensitive detection of TB and MDR-TB - The LoD determined that the concentration of TB DNA detected with 95% probability is 3.98 copies/test for RIF - The LoD of TB is copies/test for INH and copies/test for TB Figure 1. Multidrug-resistance detection method: Allele-Specific PCR Figure 2. Example of TB and MDR-TB detection Cat. no. Kit name Target Tests BIONEER MTN-1111 AccuPower MTB&NTM Real-Time PCR Kit Mycobacterium tuberculosis, Non-tuberculous mycobacteria 96 MTB-1111 AccuPower MTB Real-Time PCR Kit Mycobacterium tuberculosis 96 NTM-1111 AccuPower NTM Real-Time PCR Kit Non-tuberculous mycobacteria 96 K-4418 ExiPrep Dx Mycobacteria Genomic DNA Kit 96 14

15 B-4. Mycobacterium Tuberculosis AccuPower MTB&NTM Real-Time PCR Kit Tuberculosis (TB) is caused by a bacterium called M. tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain. It can affect mainly the lungs (pulmonary TB). Nontuberculous mycobacteria (NTM) are a group of bacteria, normally found in soil and water and some domestic and wild animals that can cause severe lung disease. The AccuPower MTB&NTM Real-Time PCR Kit is an in vitro diagnostic kit designed for the simultaneous detection of M. tuberculosis and NTM DNA in clinical samples through Real-Time PCR using ExiStation MDx System or Exicycler 96. MTN-1111 PCR premix (96rxn), MTB&NTM PC, IPC, NTC, DEPC D.W., Optical sealing film Target - Mycobacterium tuberculosis: IS6110, Non-tuberculous mycobacteria: rpob Sample type - Sputum, BAL, Urine Instrument - ExiStation, Exicycler 96 The AccuPower MTB&NTM Real-Time PCR Kit provides; Highly sensitive detection of TB - The LoD of TB (M. tuberculosis, ATCC 25177) is 20.4 copies/test A broad range of detection of 57 NTM species including the most common 8 species listed below - The LoD of M. avium is 44.7 copies/test - The LoD of M. intracellulare is copies/test - The LoD of M. abscessus is 72.4 copies/test - The LoD of M. chelonae is 52.5 copies/test - The LoD of M. kansasii is copies/test - The LoD of M. fortuitum is 53.7 copies/test - The LoD of M. gordonae is copies/test - The LoD of M. massiliense is 57.5 copies/test Figure 1. Detection of TB and NTM Positive Control using Exicycler 96. Black signal; MTB, Red signal; NTM, Blue signal; IPC Cat. no. Kit name Target Tests MTB-1111 AccuPower MTB Real-Time PCR Kit Mycobacterium tuberculosis 96 NTM-1111 AccuPower NTM Real-Time PCR Kit Non-tuberculous mycobacteria 96 TBMDR-1111 AccuPower TB&MDR Real-Time PCR Kit Mycobacterium tuberculosis, Multidrug-resistant tuberculosis (Rifampicin, Isoniazid) 48 K-4414 ExiPrep Dx Bacteria Genomic DNA Kit 96 K-4418 ExiPrep Dx Mycobacteria Genomic DNA Kit

16 B-5. Sexually Transmitted Infections AccuPower STI8A-Plex Real-Time PCR Kit 0197 Sexually Transmitted Infection (STI) is an infection that can be transferred from one person to another by means of sexual contact, including oral sex, anal sex, and sharing sex toys. Chlamydia infection is a common sexually transmitted infection in human caused by the bacterium Chlamydia trachomatis. Neisseria gonorrhoeae is pathogenic to humans who are its only natural host, and it is responsible for the disease Gonorrhea. Symptoms of infection with N. gonorrhoeae differ, depending on the site of infection. Ureaplasma urealyticum is part of the normal genital flora of both men and women. It is found in about 70% of sexually active humans. Mycoplasma genitalium is an emerging sexually transmitted pathogen implicated in urethritis in men and several inflammatory reproductive tract syndromes in women. Depending on the disease, some untreated STIs can lead to infertility, chronic pain or even death. Early identification and treatment results in less chance to spread disease and for some conditions may improve the outcomes of treatment. STI8A-1111 PCR Premix (96rxn), STI8A PC, IPC, NTC, DEPC D.W., Optical sealing film Target - Chlamydia trachomatis: ompa, Neisseria gonorrhoeae: 16s rrna, Ureaplasma urealyticum: urec, Mycoplasma genitalium: mgpa Sample type - Male urine, Female vaginal swab Instrument - ExiStation The AccuPower STI8A-Plex Real-Time PCR Kit provides; Highly sensitive detection of STI pathogens - The LoD of C. trachomatis is 8.91 copies/test - The LoD of N. gonorrhoeae is copies/test - The LoD of U. urealyticum is copies/test - The LoD of M. genitalium is copies/test Simultaneous detection of 8 STI pathogens with STI8B-Plex Real-Time PCR Kit using ExiStation MDx System High reliability through Internal Positive Control, Positive Control and No Template Control Figure 1. Detection of STI8A-Plex Positive Control using Exicycler 96. Black signal; CT, Red signal; NG, Purple signal; UU, Green signal; MG, Blue signal; IPC Cat. no. Kit name Target Tests STI8B-1111 AccuPower STI8B-Plex Real-Time PCR Kit Trichomonas vaginalis, Mycoplasma hominis, Herpes simplex virus type 1&2 96 CHT-1111 AccuPower CT Real-Time PCR Kit Chlamydia trachomatis 96 NSG-1111 AccuPower NG Real-Time PCR Kit Neisseria gonorrhoeae 96 STD2A-1211 AccuPower CT&NG Real-Time PCR Kit Chlamydia trachomatis, Neisseria gonorrhoeae 96 UUU-1111 AccuPower UU Real-Time PCR Kit Ureaplasma urealyticum 96 MPG-1111 AccuPower MG Real-Time PCR Kit Mycoplasma genitalium 96 CANGV-1111 AccuPower CA&GV Real-Time PCR Kit Candida albicans, Gardnerella vaginlais 96 BIONEER K-4414 ExiPrep Dx Bacteria Genomic DNA Kit 96 16

17 B-5. Sexually Transmitted Infections AccuPower STI8B-Plex Real-Time PCR Kit Trichomoniasis is one of the most common STIs caused by a small organism called Trichomonas vaginalis. Women are most often affected by this disease, although men can become infected and pass the infection to their partners through sexual contact. Mycoplasma hominis is a strain of bacteria that is present in the urogenital area. Infection is usually asymptomatic, but for pregnant women, infection can lead to premature birth. Herpes simplex type 1, which is transmitted through oral secretions or sores on the skin, can be spread through kissing or sharing objects such as toothbrushes or eating utensils. In general, a person can only get herpes type 2 infections during sexual contact with someone who has a genital HSV-2 infection. Depending on the disease, some untreated STIs can lead to infertility, chronic pain or even death. Early identification and treatment results in less chance to spread disease and for some conditions may improve the outcomes of treatment. STI8B-1111 PCR premix (96rxn), STI8B PC, IPC, NTC, DEPC D.W., Optical sealing film Target - Trichomonas vaginalis: β-tubulin, Mycoplasma hominis: Gap, Herpes simplex virus 1: us4, Herpes simplex virus 2: gg Sample type - Urine, Vaginal swab, Urethral swab Instrument - ExiStation, Exicycler 96 The AccuPower STI8B-Plex Real-Time PCR Kit provides; Highly sensitive detection of STI pathogens - The LoD of T. vaginalis is copies/test - The LoD of M. hominis is copies/test - The LoD of HSV 1 is copies/test - The LoD of HSV 2 is copies/test Simultaneous detection of 8 STI pathogens with STI8A-Plex Real- Time PCR Kit using ExiStation MDx System High reliability through Internal Positive Control, Positive Control and No Template Control Figure 1. Detection of STI8B-Plex Positive Control using Exicycler 96. Black signal; TV, Red signal; HSV 1, Purple signal; HSV 2, Green signal; MH, Blue signal; IPC Cat. no. Kit name Target Tests STI8A-1111 AccuPower STI8A-Plex Real-Time PCR Kit Chlamydia trachomatis, Neisseria gonorrhoeae, Ureaplasma urealyticum, Mycoplasma genitalium 96 TVG-1111 AccuPower TV Real-Time PCR Kit Trichomonas vaginalis 96 MPH-1111 AccuPower MH Real-Time PCR Kit Mycoplasma hominis 96 HSM-1111 AccuPower HSV Type 1&2 Real-Time PCR Kit Herpes simplex virus type 1&2 96 HV AccuPower HHV6 Real-Time PCR Kit Human herpes virus 6 96 HV AccuPower HHV8 Real-Time PCR Kit Human herpes virus 8 96 TGN-1111 AccuPower TG Real-Time PCR Kit Toxoplasma gondii 96 K-4414 ExiPrep Dx Bacteria Genomic DNA Kit

18 B-5. Sexually Transmitted Infections AccuPower CT&NG Real-Time PCR Kit 0197 C. trachomatis and N. gonorrhoeae are two of the most prevalent sexually transmitted pathogens, with high rates of infection among female commercial sex workers in developing countries, a substantial proportion of whom have asymptomatic infections. C. trachomatis causes cervicitis, urethritis, salpingitis, proctitis and endometritis in women and urethritis, epididymitis and proctitis in men. Acute infections are reported more frequently in men because women often have no symptoms of infection. N. gonorrhoeae causes acute urethritis in males, which if untreated can develop into epididymitis, prostatitis, and urethral stricture. In females, the primary site of infection is the endocervix. An important complication in females is development of pelvic inflammatory disease which contributes to infertility. The AccuPower CT&NG Real-Time PCR Kit is an in vitro diagnostic kit designed for the simultaneous detection of C. trachomatis and N. gonorrhoeae DNA in clinical samples through Real-Time PCR using ExiStation MDx System or Exicycler 96. STD2A-1211 PCR Premix (96rxn), CT&NG PC, IPC, NTC, DEPC D.W., Optical sealing film Target - Chlamydia trachomatis : ompa, cryptic plasmid, Neisseria gonorrhoeae: pora Sample type - Male urine, Female vaginal swab Instrument - ExiStation The AccuPower CT&NG Real-Time PCR Kit provides Highly sensitive detection of C. trachomatis and N. gonorrhoeae - The LoD of C. trachomatis is 9.12 copies/test - The LoD of N. gonorrhoeae is 8.71 copies/test High reliability through Internal Positive Control, Positive Control and No Template Control Figure 1. Detection of CT & NG Positive Control using Exicycler 96. Black signal; CT, Red signal; NG, Blue signal; IPC Cat. no. Kit name Target Tests STI8A-1111 AccuPower STI8A-Plex Real-Time PCR Kit Chlamydia trachomatis, Neisseria gonorrhoeae, Ureaplasma urealyticum, Mycoplasma genitalium 96 STI8B-1111 AccuPower STI8B-Plex Real-Time PCR Kit Trichomonas vaginalis, Mycoplasma hominis, Herpes simplex virus type 1&2 96 CHT-1111 AccuPower CT Real-Time PCR Kit Chlamydia trachomatis 96 NSG-1111 AccuPower NG Real-Time PCR Kit Neisseria gonorrhoeae 96 UUU-1111 AccuPower UU Real-Time PCR Kit Ureaplasma urealyticum 96 MPG-1111 AccuPower MG Real-Time PCR Kit Mycoplasma genitalium 96 CANGV-1111 AccuPower CA&GV Real-Time PCR Kit Candida albicans, Gardnerella vaginlais 96 K-4414 ExiPrep Dx Bacteria Genomic DNA Kit 96 BIONEER 18

19 B-5. Sexually Transmitted Infections AccuPower CT Real-Time PCR Kit 0197 C. trachomatis is the most common curable sexually transmitted infection. Approximately 5-10% of sexually active women under 24 and men between may be currently infected. Even though symptoms of chlamydia are usually mild or absent, serious complications that cause irreversible damage, including infertility. Chlamydia can occur silently before a woman ever recognizes a problem. Chlamydia can also cause discharge from the penis of an infected man. Chlamydia can be transmitted during vaginal, anal, or oral sex. Chlamydia can also be passed from an infected mother to her baby during vaginal childbirth. The AccuPower CT Real-Time PCR Kit is an in vitro diagnostic kit designed for the detection of C. trachomatis DNA in clinical samples through Real-Time PCR using ExiStation MDx System or Exicycler 96. CHT-1111 PCR Premix (96rxn), CT PC, IPC, NTC, DEPC D.W., Optical sealing film Target - Chlamydia trachomatis: ompa Sample type - Male urine, Female vaginal swab Instrument - ExiStation The AccuPower CT Real-Time PCR Kit provides Highly sensitive detection of C. trachomatis - The LoD is 6.16 copies/test High reliability through Internal Positive Control, Positive Control and No Template Control Figure 1. Detection of CT Positive Control using Exicycler 96. Black signal; CT, Blue signal; IPC Cat. no. Kit name Target Tests STI8A-1111 AccuPower STI8A-Plex Real-Time PCR Kit Chlamydia trachomatis, Neisseria gonorrhoeae, Ureaplasma urealyticum, Mycoplasma genitalium 96 STI8B-1111 AccuPower STI8B-Plex Real-Time PCR Kit Trichomonas vaginalis, Mycoplasma hominis, Herpes simplex virus type 1&2 96 STD2A-1211 AccuPower CT&NG Real-Time PCR Kit Chlamydia trachomatis, Neisseria gonorrhoeae 96 NSG-1111 AccuPower NG Real-Time PCR Kit Neisseria gonorrhoeae 96 UUU-1111 AccuPower UU Real-Time PCR Kit Ureaplasma urealyticum 96 MPG-1111 AccuPower MG Real-Time PCR Kit Mycoplasma genitalium 96 CANGV-1111 AccuPower CA&GV Real-Time PCR Kit Candida albicans, Gardnerella vaginlais 96 K-4414 ExiPrep Dx Bacteria Genomic DNA Kit

20 B-6. Transplantation related Virus AccuPower CMV Quantitative PCR Kit Human cytomegalovirus (HCMV) infection is acquired subclinically during childhood. It is usually transmitted via body fluid, blood, solid organ transplant and stem cell transplant recipients. Thus, monitoring of CMV viral load is essential for newborns and transplant recipients. The AccuPower CMV Quantitative PCR Kit is an in vitro diagnostic kit designed for the quantification of CMV DNA in clinical samples through Real-Time PCR using ExiStation MDx System or Exicycler 96. Target - Human Cytomegalovirus: glycoprotein B (gb) Sample type - Whole blood, EDTA-plasma Instrument - ExiStation, Exicycler 96 CMV-1111 PCR premix (96rxn), SPCs (S1~S5), IPC, NTC, DEPC D.W., SL buffer, Optical sealing film The AccuPower CMV Quantitative PCR Kit provides; Highly sensitive detection of human cytomegalovirus (Table 1) - The LoD is 66 IU/ml (400 ul EDTA-plasma) - The LoQ is 100 IU/ml (400 ul EDTA-plasma) Simplified procedure by eliminating clinical sample pretreatment step - Whole blood, urine and breast milk samples can be directly used for the quantification of CMV viral load using ExiStation MDx System Specific Real-Time PCR reaction by Dual-HotStart technology Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower CMV Quantitative PCR Kit. Black signal; CMV, Blue signal; IPC Table 1. Performance of AccuPower CMV Quantitative PCR Kit Sample type LoD (IU/ml) LoQ (IU/ml) Quantitative Range (IU/ml) EDTA-plasma ~ 2x10 7 Whole blood ~ 6x10 7 Cat. no. Kit name Target Tests EBV-1111 AccuPower EBV Quantitative PCR Kit Epstein-Barr virus 96 BKV-1111 AccuPower BKV Quantitative PCR Kit BK virus 96 K-4471 ExiPrep Dx Viral DNA/RNA Kit 96 K-4472 ExiPrep Dx Viral DNA Kit 96 K-4474 ExiPrep Dx Blood Viral DNA Kit 96 BIONEER 20

21 B-6. Transplantation related Virus AccuPower EBV Quantitative PCR Kit Epstein-Barr virus (EBV) or HHV-4 is a ubiquitous virus that infects humans worldwide. EBV is associated with a spectrum of clinical presentations on transplant recipients, from fever to post-transplantation lymphoproliferative disorder (PTLD). Increasing EBV viral loads have been demonstrated to correlate with the development of EBV related diseases and quantitative PCR is considered a valuable tool to monitor patients with high risk of PTLD. The AccuPower EBV Quantitative PCR Kit is an in vitro diagnostic kit designed for the quantification of EBV DNA in human whole blood and EDTA-plasma samples through Real-Time PCR using ExiStation MDx System or Exicycler 96. EBV-1111 PCR premix (96rxn), SPCs (S1~S5), LPC,HPC, IPC, NTC, DEPC D.W., SL buffer, Optical sealing film Target - Epstein-Barr virus (EBV) : glycoprotein Sample type - Whole blood, EDTA-plasma Instrument - ExiStation, Exicycler 96 The AccuPower EBV Quantitative PCR Kit provides; Highly sensitive detection of Epstein-Barr virus (Table 1) - The LoD is 79 IU/ml (400 ul EDTA-plasma) - The LoQ is 100 IU/ml (400 ul EDTA-plasma) Simplified procedure by eliminating clinical sample pretreatment step - Whole blood and EDTA-plasma samples can be directly used for the quantification of EBV viral load using ExiStation MDx System Specific Real-Time PCR reaction by Dual-HotStart technology Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower EBV Quantitative PCR Kit. Black signal; EBV, Blue signal; IPC Table 1. Performance of AccuPower EBV Quantitative PCR Kit Sample type LoD (IU/ml) LoQ (IU/ml) Quantitative Range (IU/ml) EDTA-plasma ~ 2.5x10 8 Serum ~ 10 8 Whole blood ~ 10 7 Cat. no. Kit name Target Tests CMV-1111 AccuPower CMV Quantitative PCR Kit Human cytomegalovirus 96 BKV-1111 AccuPower BKV Quantitative PCR Kit BK virus 96 K-4471 ExiPrep Dx Viral DNA/RNA Kit 96 K-4472 ExiPrep Dx Viral DNA Kit 96 K-4474 ExiPrep Dx Blood Viral DNA Kit

22 B-6. Transplantation related Virus AccuPower BKV Quantitative PCR Kit BK virus (BKV) was originally discovered and isolated from the urine of a renal allograft recipient. The source of BKV infection is due to decline in immunologic activity from either graft dysfunction and graft rejection in renal transplant recipients under immunosuppressed state. The AccuPower BKV Quantitative PCR Kit is an in vitro diagnostic kit designed for the quantification of BKV DNA in urine and serum samples through Real-Time PCR using ExiStation MDx System or Exicycler 96. BKV-1111 PCR premix (96rxn), SPCs(S1~S5), IPC, NTC, DEPC D.W., SL buffer, Optical sealing film Target - BK virus (BKV) : Small T antigen Sample type - Serum, Urine Instrument - ExiStation, Exicycler 96 The AccuPower BKV Quantitative PCR Kit provides; Highly sensitive detection of BK virus (Table 1) - The LoD is 78 copies/ml (400 ul serum) - The LoQ is 150 copies/ml (400 ul serum) Simplified procedure by eliminating clinical sample pretreatment step - Serum and urine samples can be directly used for the quantification of BKV viral load using ExiStation MDx System High performance of repeatability and reproducibility (Table 2) Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower BKV Quantitative PCR Kit. Black signal; BKV, Blue signal; IPC Table 1. Performance of The AccuPower BKV Quantitative PCR Kit Table 2. Repeatability and reproducibility of AccuPower BKV Quantitative PCR Kit Sample type LoD (copies/ml) LoQ (copies/ml) Quantitative Range (copies/ml) Conc. (copies/ml) Within-run Between-day Between-batch SD (copies/ml) SD (copies/ml) SD (copies/ml) Serum Cat. no. Kit name Target Tests CMV-1111 AccuPower CMV Quantitative PCR Kit Human cytomegalovirus 96 EBV-1111 AccuPower EBV Quantitative PCR Kit Epstein-Barr virus 96 K-4471 ExiPrep Dx Viral DNA/RNA Kit 96 K-4472 ExiPrep Dx Viral DNA Kit 96 BIONEER 22

23 B-7. Human Papillomavirus AccuPower HPV 16&18 Real-Time PCR Kit The global incidence and death from cervical cancer rank the second and third highest respectively among women. The main cause of cervical cancer is Human papillomavirus (HPV) in the cervix. According to the study with 196 patients in cervical adenocarcinoma, HPV genotype 18 is responsible for cervical cancer in 54.2% of the patients; HPV 16, in 44.1%. The AccuPower HPV 16&18 Real-Time PCR Kit is an in vitro diagnostic kit designed for the simultaneous detection of HPV type 16 and 18 DNA in human cervical swab samples through Real-Time PCR. The kit is configured for use with ExiStation MDx System or Exicycler 96. HPM-1111 PCR premix (96rxn), PC, IPC, DEPC D.W., Optical sealing film Target - Human Papillomavirus type 16, Human Papillomavirus type 18 Sample type - Cervical swab Instrument - ExiStation, Exicycler 96 The AccuPower HPV 16&18 Real-Time PCR Kit provides; Highly sensitive detection of HPV type 16 and 18 - The LoD of HPV type 16 is copies/test - The LoD of HPV type 18 is copies/test High reliability through Internal Positive Control and Positive Control (Figure 1) Simultaneous detection of high risk HPV type 16 and 18 Specific Real-Time PCR reaction using Enzyme-mediated HotStart technology Diagnostic Evaluation and Correlation with Reference Method The clinical evaluation of the AccuPower HPV 16&18 Real-Time PCR Kit was performed on 22 clinical samples. Out of 22 samples, the AccuPower HPV16&18 Real-Time PCR Kit determined four specimens as HPV16-positive, another four as HPV18-positive, another four as HPV16 and 18-positive, the rest ten as negative. Those results agreed 100% with those from direct sequencing results (Table 1). Figure 1. Detection of HPV 16&18 Positive Control using Exicycler 96. Black signal; HPV16, Red signal; HPV18, Blue signal; IPC Table 1. Comparison of Bioneer HPV16&18 kit with Reference method Cat. no. Kit name Target Tests HPG-1111 AccuPower HPV Genotyping Kit Human Papillomavirus 27genotypes 12 K-4471 ExiPrep Dx Viral DNA/RNA Kit 96 K-4472 ExiPrep Dx Viral DNA Kit

24 B-7. Human Papillomavirus AccuPower HPV Genotyping Kit The global incidence and death from cervical cancer rank the second and third highest respectively among women. The main cause of cervical cancer is Human papillomavirus (HPV) in the cervix. There are over 100 different types of HPV. HPV types are often referred to as low-risk or high-risk, based on whether they put a person at risk for cervical cancer. The AccuPower HPV Genotyping Kit is an in vitro diagnostic kit designed for the simultaneous detection of 27 HPV genotypes in human cervical or vaginal swab samples through Real-Time PCR. The kit is configured for use with Exicycler 96. HPG-1111 PCR premix (12rxn), PC, DEPC D.W., Optical sealing film Target - Human Papillomavirus 27 genotypes (Table 1) Sample type - Cervical swab, Vaginal swab Instrument - Exicycler 96 The AccuPower HPV Genotyping Kit provides; Simultaneous detection of 19 high risk HPV genotypes and 8 low risk HPV genotypes Highly sensitive detection of HPV genotypes (Table 1) Specific Real-Time PCR reaction using Enzyme-mediated HotStart technology Compliance with CE-IVD / MFDS Diagnostic Evaluation with Reference Method The clinical evaluation of the AccuPower HPV Genotyping Kit was performed on 5 clinical samples. AccuPower HPV Genotyping Kit provided more sensitive results than DNA chip assay. (Figure 1, Table 2) Table 1. The LoD of AccuPower HPV Genotype Kit (copy/test) HPV High Risk HPV Low Risk Genotype LoD Genotype LoD Genotype LoD Figure 1. Clinical sample test results of AccuPower HPV Genotyping Kit (flu. graph) Table 2. Evaluation results of AccuPower HPV Genotyping Kit. & DNA chip assay using clinical samples Sample No. DNA chip assay Bioneer result Others Others 33 5 Negative Negative Cat. no. Kit name Target Tests HPM-1111 AccuPower HPV 16&18 Real-Time PCR Kit Human Papillomavirus 16 & BIONEER K-4471 ExiPrep Dx Viral DNA/RNA Kit 96 K-4472 ExiPrep Dx Viral DNA Kit 96 24

25 B-8. Respiratory Pathogens AccuPower New InfA (H1N1) & InfA Real-Time RT-PCR Kit Influenza occurs all over the world, with an annual global attack rate estimated at 5 10% in adults and 20 30% in children. In temperate regions, influenza is a seasonal disease occurring typically in winter months. The subtypes of influenza A viruses are determined by envelope glycoproteins possessing either haemagglutinin (HA) or neuraminidase (NA) activity. Influenza A (H1N1) virus emerged in 2009 is a new reassortment that has never before circulated among humans. This virus is not closely related to previous or current human seasonal influenza viruses. The AccuPower New InfA (H1N1) & InfA Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for the detection of influenza A (H1N1-2009, common) virus RNA in clinical samples through Real-Time PCR using Exicycler 96. SIA-1111 New InfA(H1N1) PCR premix (48rxn), Influenza A PCR Premix (48rxn), PC, IPC, DEPC D.W., Optical sealing film Target - New Influenza A (H1N1) : HA gene, Influenza A : matrix protein gene Sample type - Nasopharyngeal swab, BAL Instrument - Exicycler 96 The AccuPower New InfA (H1N1) & InfA Real-Time RT-PCR Kit provides; Highly sensitive detection of influenza A and new influenza A (H1N1-2009) - The LoD of new influenza A (H1N1-2009) is copies/ml - The LoD of influenza A is copies/ml High reliability through Internal Positive Control and Positive Control One-Step Real-Time RT-PCR reaction using RocketScript Reverse Transcriptase and Dual-HotStart technology Figure 1. Detection of new Influenza A (H1N1) Positive Control using Exicycler 96. Black signal; new InfA(H1N1), Blue signal; IPC Figure 2. Detection of Influenza A Positive Control using Exicycler 96. Black signal; InfA, Blue signal; IPC Cat. no. Kit name Target Tests IFA-1111 AccuPower Influenza A Real-Time RT-PCR Kit Influenza A 96 SIV-1111 AccuPower New InfA (H1N1) Real-Time RT-PCR Kit New Influenza A (H1N1) 96 K-4471 ExiPrep Dx Viral DNA/RNA Kit 96 K-4473 ExiPrep Dx Viral RNA Kit

26 B-8. Respiratory Pathogens AccuPower CP Real-Time PCR Kit Chlamydia pneumoniae is a species of Chlamydophila, an obligate intracellular bacterium that infects humans and is a major cause of pneumonia. Outbreaks of C. pneumoniae occur mostly in crowded environments, like schools, college dormitories, military barracks, and nursing homes, where transmission is possible through airborne droplets from close person-to-person contact. C. pneumoniae causes mild pneumonia or bronchitis in adolescents and young adults. Older adults may experience more severe disease and repeated infections. The AccuPower CP Real-Time PCR Kit is an in vitro diagnostic kit designed for the detection of C. pneumonia DNA in clinical samples through Real-Time PCR using ExiStation MDx System or Exicycler 96. CPN-1111 PCR premix (96rxn), PC, IPC, NTC, DEPC D.W., Optical sealing film Target - Chlamydia pneumoniae: LKK-1 outer membrane protein A Sample type - Sputum, BAL Instrument - ExiStation, Exicycler 96 The AccuPower CP Real-Time PCR Kit provides; Highly sensitive detection of C. pneumoniae - The LoD is 60.3 copies/ml Simplified procedure of sputum pretreatment with EZ Solution Low coefficient of variation (CV) for between-day precision and inter-instrument trueness within 1.74 % No interference observed in the presence of the interfering substances such as blood and hemoglobin Figure 1. Detection of CP Positive Control using Exicycler 96. Black signal; CP, Blue signal; IPC Cat. no. Kit name Target Tests MPN-1111 AccuPower MP Real-Time PCR Kit Mycoplasma pneumoniae 96 K-4414 ExiPrep Dx Bacteria Genomic DNA Kit 96 K-4418 ExiPrep Dx Mycobacteria Genomic DNA Kit 96 BIONEER 26

27 B-8. Respiratory Pathogens AccuPower MP Real-Time PCR Kit Mycoplasma pneumonia is a form of atypical bacterial pneumonia caused by the bacterial species Mycoplasma pneumoniae. In general, M. pneumoniae infection is a mild illness that is most common in young adults and school-aged children. The most common type of illness, that is caused by the bacteria, especially in children, is tracheobronchitis, commonly called a chest cold. Diagnosis of M. pneumoniae infections is complicated by the delayed onset of symptoms and the similarity of symptoms to other pulmonary conditions. Among other diagnostic tools, PCR is the most rapid and effective way to determine the presence of M. pneumoniae. The AccuPower MP Real-Time PCR Kit is an in vitro diagnostic kit designed for the detection of M. pneumonia DNA in sputum, BAL and throat swab samples through Real-Time PCR using ExiStation MDx System or Exicycler 96. MPN-1111 PCR premix (96rxn), PC, IPC, NTC, DEPC D.W., Optical sealing film Target - Mycoplasma pneumoniae : cytohesin P1 Sample type - Sputum, BAL Instrument - ExiStation, Exicycler 96 The AccuPower MP Real-Time PCR Kit provides; Highly sensitive detection of M. pneumoniae - The LoD is copies/ml Simplified procedure of sputum pretreatment with EZ Solution Low coefficient of variation (CV) for between-day precision and interinstrument trueness within 1.89 % No interference observed in the presence of the interfering substances such as blood and hemoglobin Figure 1. Detection of MP Positive Control using Exicycler 96. Black signal; MP, Blue signal; IPC Cat. no. Kit name Target Tests CPN-1111 AccuPower CP Real-Time PCR Kit Chlamydia pneumoniae 96 K-4414 ExiPrep Dx Bacteria Genomic DNA Kit 96 K-4418 ExiPrep Dx Mycobacteria Genomic DNA Kit

28 B-8. Respiratory Pathogens AccuPower MERS-CoV (upe&orf1a) Real-Time PCR Kit Middle East respiratory syndrome (MERS) is a viral respiratory illness caused by a coronavirus called MERS-CoV. It was first reported in Saudi Arabia in 2012 and has spread to other countries including South Korea. Camels and bats are suspected to be the primary source of the infection for humans. MERS causes high fever, cough, and severe shortness of breath, and can also leads up to kidney failure and even death in patients who had a history of other medical conditions. There are currently no vaccines for MERS and no treatments available to cure the infection. The AccuPower MERS-CoV Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for the detection of MERS-CoV upstream of E gene (upe) and Open reading frame 1a (ORF1a) gene in human sputum, nasopharyngeal swab and bronchial alveolar lavage (BAL) through real-time polymerase chain reaction (PCR) using ExiStation MDx System or Exicycler 96. COV-1112 PCR premix (48rxn), PC, IPC, NTC, DEPC D.W., Optical sealing film Target - upe, ORF1a Sample type - Sputum, Nasopharyngeal swab, Bronchoalveolar lavage (BAL) Instrument - ExiStation, Exicycler 96 The AccuPower MERS-CoV (upe&orf1a) Real-Time PCR Kit provides; Highly sensitive detection of MERS-CoV - The upe LoD is copies/ml - The ORF1a LoD is copies/ml High reliability through IPC, PC and NTC Specific one-step Real-Time RT-PCR reaction using Dual-HotStart technology Figure 1. Detection of MERS-CoV (upe) Positive Control using Exicycler 96. Black signal; MERS-CoV(upE), Blue signal; IPC Figure 2. Detection of MERS-CoV (ORF1a) Positive Control using Exicycler 96 Green signal; MERS-CoV(ORF1a), Blue signal; IPC Cat. no. Kit name Target Tests COV-1111 AccuPower MERS-CoV Real-Time RT-PCR Kit MERS-CoV (upe) 96 K-4473 ExiPrep Dx Viral RNA Kit 96 BIONEER 28

29 R R B-9. Gastrointestinal Pathogens AccuPower Norovirus Real-Time RT-PCR Kit Norovirus is an RNA virus of the Caliciviridae family and infects people regardless of age and infection occurs sporadically throughout the world. The potential for norovirus infection can occur in food poisoning even with very low virus numbers, and transmission through bodily fluids. The AccuPower Norovirus Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for the detection of norovirus GI/GII RNA in human stool or rectal swab samples through Real-Time PCR using Exicycler 96 or ABI systems. Target - Norovirus GI, GII:, Norovirus Open Reading Frame (ORF) 2 and 3 Sample type - Stool, Rectal swab Instrument - Exicycler 96, ABI 7300/7500/7500 Fast NOR-1111/1112 PCR premix (96rxn), PC, IPC, NTC, DEPC D.W., Optical sealing film The AccuPower Norovirus Real-Time RT-PCR Kit provides; Highly sensitive detection of various subtypes of norovirus (GI:1 to 9, GII:1 to 22) - The LoD of GI is 1,264 copies/ml - The LoD of GII is 696 copies/ml Multiplex detection of norovirus GI and GII in one tube Specific one-step Real-Time RT-PCR reaction using Dual-HotStart technology Figure 1. Detection of Norovirus Positive Control using Exicycler 96. Red signal; GI, Black signal; GII, Blue signal; IPC RIDASCREEN ELISA RIDAGENE Real-Time PCR kit AccuPower Real-TimePCR kit No. of specimen(%) Positive Positive Positive 91 (32.4%) Positive Positive Negative 0 (0.0%) Positive Negative Positive 2 (0.7%) Positive Negative Negative 16 (5.7%) Negative Positive Positive 5 (1.8%) Negative Positive Negative 1 (0.4%) Negative Negative Positive 7 (2.5%) Negative Negative Negative 159 (56.6%) Total 281 (100%) Tabel 1. Comparison of the results Percent positive agreement of AccuPower PCR kit compared to RIDAGENE PCR kit: 99.0% (96/97) (95% CI, %). Percent negative agreement of AccuPower PCR kit compared to RIDAGENE PCR kit: 95.1% (175/184) (95% CI, %). Among 10 specimen (3.6%) with discordant results between the 2 Real-Time PCR, 7 specimen were confirmed norovirus GII positive by direct sequencing which results were in agreement with AccuPower PCR kit results. Genotype No. of samples No. of detected Detection rate by AccuPower Real-Time PCR kit GL % GL % GIL % GIL % GIL % GIL % GIL untyped or no sample for genotyping RIDAGENE PCR positive, 1 0 no sample for genotyping Total % Table 2. Detectability of norovirus genotypes by AccuPower Real-Time PCR kits *J. Hyun et al. / Diagnostic Microbiology and Infectious Disease 78(2014) Cat. no. Kit name Instrument Tests NOR-1111 AccuPower Norovirus Real-Time RT-PCR Kit Exicycler NOR-1112F AccuPower Norovirus Real-Time RT-PCR Kit ABI 7500 Fast system 96 NOR-1112S AccuPower Norovirus Real-Time RT-PCR Kit ABI 7300, K-4471 ExiPrep Dx Viral DNA/RNA Kit 96 K-4473 ExiPrep Dx Viral RNA Kit

30 B-9. Gastrointestinal Pathogens AccuPower EV Real-Time RT-PCR Kit Enterovirus can be classified into one of five major groups, including polioviruses, echoviruses, coxsackieviruses A, coxsackieviruses B and other enteroviruses. Infected persons who become ill usually develop mild upper respiratory symptoms (a cold ), a flu-like illness with fever and muscle aches, or an illness with rash. Rarely, a person may develop an illness that affects the heart (myocarditis) or the brain (encephalitis) or causes paralysis. The AccuPower EV Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for the detection of enterovirus RNA in human stool or cerebrospinal fluid (CSF) samples through Real-Time PCR using Exicycler 96. ENT-1111 PCR premix (96rxn), PC, IPC, NTC, DEPC D.W., Optical sealing film Target - Enterovirus: 5 UTR Sample type - Stool, Cerebrospinal fluid (CSF) Instrument - Exicycler 96 The AccuPower EV Real-Time RT-PCR Kit provides; Highly sensitive detection of various enterovirus serotypes (Table 1) - The LoD is 309 copies/ml Specific one-step Real-Time RT-PCR reaction using Dual-HotStart TM technology Table1. Detectable Enterovirus Serotypes Detectable serotype Enterovirus 71, 76, 77, 79, 80, 82, 83, 87, 97, 101, B, yanbian96-83 Coxackievirus A A2, A3, A4, A5, A6, A8, A9, A10, A12, A14, A15, A16, A18, A20, A24 Coxackievirus B B1, B2, B3, B4, B5 Echovirus 3, 4, 6, 7, 9, 11, 13, 14, 16, 17, 18, 21, 24, 25, 30, 32, 33 Poliovirus 1, 2, 3 Total 52 serotypes Figure 1. Detection of Enterovirus Positive Control using Exicycler 96. Black signal; Enterovirus, Blue signal; IPC AccuPower Enterovirus 71 Real-Time RT-PCR Kit E Enterovirus 71 (EV71) is one of a large family of viruses which multiply in the human gastrointestinal tract (gut). The EV71 infection may be asymptomatic or it may cause diarrhea, rashes, and hand, foot and mouth disease (HFMD). Furthermore, EV71 infections can also cause neurological and systemic complications such as aseptic meningitis, acute flaccid paralysis, and encephalitis (usually in the brainstem). Children under 5 years old, especially those under 2 years, are at higher risk of developing a severe EV71 infection. The AccuPower Enterovirus 71 Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for the detection of enterovirus 71 RNA in clinical samples through Real-Time PCR using Exicycler 96. Target - Enterovirus 71: VP1 Sample type - Stool, Cerebrospinal fluid (CSF) Instrument -Exicycler 96 The AccuPower Enterovirus 71 Real-Time RT-PCR Kit provides; Highly sensitive detection of Enterovirus 71 - The LoD is copies/ml Specific one-step Real-Time RT-PCR reaction using Dual-HotStart technology BIONEER 30 Cat. no. Kit name Tests K-4471 ExiPrep Dx Viral DNA/RNA Kit 96 K-4473 ExiPrep Dx Viral RNA Kit 96

31 B-10. Human Genotyping AccuPower ApoE Real-Time PCR Kit Human apolipoprotein E (ApoE) is a major component of lipoproteins and has an important role in lipoprotein metabolism. ApoE has 3 common alleles (ε2, ε3, ε4) which encode three isoforms of ApoE protein E2, E3, and E4. AccuPower ApoE Real-Time PCR Kit is designed to determine the genotype of ApoE codon change (112 Arg/Cys, 158 Cys/Arg). The kit is configured for use with Exicycler 96 (ExiGenotyper software). Target - Human ApoE SNP (Cys112Arg, Arg158Cys) Sample type - Human whole blood, Human buccal swab Instrument - Exicycler 96 (ExiGenotyper software) APE-1111 PCR premix (24rxn), PCs (E1/E3), DEPC D.W., Optical sealing film The AccuPower ApoE Real-Time PCR Kit provides; Distinct and direct detection of ApoE 6 genotype through allele-specific PCR method Highly sensitive detection of ApoE genotype (Table 1) - The LoD is 10 ng/test - Detectable range is 10 ~ 200 ng/test No interference observed in the presence of the interfering substances such as EDTA, albumin, hemoglobin, cholesterol, etc. Table 1. Limit of Detection of AccuPower ApoE Real-Time PCR Kit ApoE SNP 112 (Cys 112 Arg) Conc. Sample size S.D C.V(%) (ng/test) Conc. (ng/test) ApoE SNP 158 (Cys 158 Arg) Sample size S.D C.V(%) Correlation with Reference Method Comparison of the AccuPower ApoE Real-Time PCR Kit with directsequencing was performed on 6 clinical samples. AccuPower ApoE Real-Time PCR Kit determined that 6 specimens were 100% agreement with direct-sequencing method. Real-Time PCR assay using a kit from company A showed almost false-genotyping result compared with direct-sequencing method (Table 2). Table 2. Comparison test results of AccuPower ApoE Real-Time PCR Kit and Direct-sequencing Method AccuPower ApoE Real -Time PCR Kit Direct -sequencing E2/E3 E2/E4 E3/E3 E4/E4 E2/E3 1 E2/E4 2 E3/E3 1 E4/E4 2 Auto-interpretation of ApoE gene SNPs ExiGenotyper software automatically interprets ApoE SNP results in realtime. ApoE phenotypes and genotypes are analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure1). Figure 1. Example of AccuPower ApoE Real-Time PCR Kit result Cat. no. Kit name Tests K-4411 ExiPrep Dx Blood Genomic DNA Kit

32 B-10. Human Genotyping AccuPower Warfarin genotyping Kit Warfarin as a coumarin derivative is an anticoagulant that inhibits the biosynthesis of coagulant factor. Determining an optimal warfarin dose is essential to reduce side effect like hemorrhage. With this, analysis of SNPs in the genes, VKORC1 and CYP2C9, is shown to be closely related to the metabolism of anticoagulation drugs such as warfarin in individuals. This is why a fast and reliable test method is essential for prompt dose adjustment to prevent serious over- or under-dosing effects. AccuPower Warfarin genotyping Kit is designed to determine the genotype of warfarin SNPs within VKORC1 and CYP2C9 gene. The kit is configured for use with Exicycler 96 (ExiGenotyper software). WAF-1111 PCR premix (12rxn), PCs (W1/W2/W3/W4/ W5/W6/W7/W8), DEPC D.W., Optical sealing film. Target - * Human VKORC1 gene SNP (3673 G>A, 6484 C>T, 6853G>C, 9041 G>A) * Human CYP2C9 gene SNP (430 C>T, 1075 A>C) Sample type - Human whole blood, Human buccal swab Instrument - Exicycler 96 (ExiGenotyper software) The AccuPower Warfarin genotyping Kit provides; Distinct and direct detection of wafarin SNP genotype through allele-specific PCR method Highly sensitive detection of warfarin SNP genotype - The LoD is 10 ng/test - Detectable range is 10 ~ 200 ng/test No interference observed in the presence of the interfering substances such as albumin, cholesterol, bilirubin, etc. Table 1. Comparison test results of AccuPower Warfarin genotyping Kit *Thrombosis Research Volume 130, Issue 1, Pages , July 2012 Diagnostic Evaluation and Correlation with Reference Method The clinical evaluation of the AccuPower Warfarin genotyping Kit was performed on 82 clinical samples. AccuPower Warfarin genotyping assay determined that 82 specimen results were 100% agreement with direct-sequencing method (Table 1). Automatic Analysis of VKORC1/CYP2C9 SNPs ExiGenotyper software automatically interprets warfarin SNP results in real-time. Warfarin SNP genotypes are analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure 1). Figure1. Example of AccuPower Warfarin genotyping Kit result Cat. no. Kit name Tests K-4411 ExiPrep Dx Blood Genomic DNA Kit 96 BIONEER 32

33 B-10. Human Genotyping AccuPower HLA-B27 Real-Time PCR Kit The function of the human leukocyte antigen (HLA) system is to present antigen molecules to a variety of cell types including most immune cells. The HLA system plays a large role in infectious diseases, graft rejection and autoimmunity. HLA-B27 serotype is found in more than 90% of ankylosing spondylitis patients. HLA genes have been extensively investigated in the clinic and are screened for organ transplant fitness screening or DNA fingerprinting. AccuPower HLA-B27 Real-Time PCR Kit is designed to detect HLA-B27 gene and configured for use with Exicycler 96 (ExiGenotyper software). HLB-1111 PCR premix (96rxn), PC, NC, NTC, DEPC D.W., Optical sealing film Target - Human HLA-B27 gene Sample type - Human whole blood, Human buccal swab Instrument - Exicycler 96 (ExiGenotyper software) The AccuPower HLA-B27 Real-Time PCR Kit provides; Specific detection of HLA-B27 gene Table 1. Comparison test results of AccuPower HLA-B27 Real-Time PCR Kit and A/B Univ. hospitals on clinical samples. Highly sensitive detection of HLA-B27 gene - The LoD is 0.26 ng/test (Cut-off is 10 ng/ul) - Detectable range is 10 ~ 200 ng/test No interference observed in the presence of the interfering substances such as EDTA, hemoglobin, albumin, cholesterol, etc. Diagnostic Evaluation and Correlation with Reference Method The clinical evaluation of the AccuPower HLA-B27 Real-Time PCR Kit was performed on 166 clinical samples. AccuPower HLA-B27 Real- Time PCR kit was showed sensitivity of 98%, specificity of 100 % (Table 1). Automatic Analysis of HLA-B27 Detection Results ExiGenotyper software automatically analyzes HLA-B27 gene detection results in real-time. The results are analyzed based on the Ct value calculated from each sample amplification result (Figure 1). Figure1. Example of AccuPower HLA-B27 Real-Time PCR Kit result Green signal; HLA-B27, Black signal; IPC Cat. no. Kit name Tests K-4411 ExiPrep Dx Blood Genomic DNA Kit

34 B-10. Human Genotyping AccuPower CYP2C19 Real-Time PCR Kit The CYP2C19 gene is a subtype of cytocrome p450 which is known to be involved in drug metabolism like a plavix. If CYP2C19 SNP genotype is a varient type, the drug metabolism is poor (PM; poor metabolism). If CYP2C19 SNP genotype is a heterozygous type, the drug metabolism is intermediate (IM; Intermediate metabolism). AccuPower CYP2C19 Real-Time PCR Kit is designed to determine the genotype of CYP2C19 SNPs and configured for use with Exicycler 96 (ExiGenotyper software). Target - Human CYP2C19 gene SNPs (*2, *3) C PCR premix (24rxn), PCs (W/M), DEPC D.W., Optical sealing film Sample type - Human whole blood, Human buccal swab Instrument - Exicycler 96 (ExiGenotyper software) The AccuPower CYP2C19 Real-Time PCR Kit provides; Distinct and direct detection of CYP2C19 SNP genotype through allele- specific PCR method Table 1. Comparison test results of AccuPower CYP2C19 Real-Time PCR Kit and direct-sequencing. Highly sensitive detection of CYP2C19 SNP - The LoD is 1 ng/test - Detectable range is 1 ~ 200 ng/test No interference observed in the presence of the interfering substances such as EDTA, hemoglobin, albumin, cholesterol, etc. Diagnostic Evaluation and Correlation with Reference Method The clinical evaluation of the AccuPower CYP2C19 Real-Time PCR Kit was performed on 59 clinical samples for comparison test with reference method, CE IVD certified kit, and 26 clinical samples for comparison test with direct-sequencing method. AccuPower CYP2C19 Real-Time PCR kit was showed 100% agreement with CE IVD certified kit and direct-sequencing method (Table 1). Automatic Analysis of CYP2C19 *2, *3 SNPs ExiGenotyper software automatically interprets CYP2C19 SNP results in real-time. CYP2C19 SNP genotypes are analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure 1). Figure1. Example of AccuPower CYP2C19 Real-Time PCR Kit result. Cat. no. Kit name Tests K-4411 ExiPrep Dx Blood Genomic DNA Kit 96 BIONEER 34

35 B-10. Human Genotyping AccuPower TPMT genotyping Real-Time PCR Kit The TPMT (Thiopurine S-methyltransferase) gene encodes a protein that catalyses S-methylation of aromatic & heterocyclic sulfhydryl compounds. If a normal dose is prescribed to patients with a reduced TPMT activity, a side effect like a pancytopenia may occur. TPMT activity can be estimated through the SNP genotyping of the TPMT gene (238 G>C, 460 G>A, 719 A>G). AccuPower TPMT genotyping Real-Time PCR Kit is designed to determine the genotype of TPMT SNPs and configured for use with Exicycler 96 (ExiGenotyper software). Target - Human TPMT gene SNPs (*2, *3A, *3C) Sample type - Human whole blood, Human buccal swab Instrument - Exicycler 96 (ExiGenotyper software) TPM-1111 PCR premix (12rxn), PCs (T1/T2/T3/T4/T5/T6), DEPC D.W., Optical sealing film The AccuPower TPMT genotyping Real-Time PCR Kit provides; Distinct and direct detection of TPMT SNP genotype through allelespecific PCR method Highly sensitive detection of TPMT SNP - The LoD is 1 ng/test - Detectable range is 1 ~ 200 ng/test No interference observed in the presence of the interfering substances such as albumin, cholesterol, billirubin, etc. Table 1. Comparison test results of AccuPower TPMT genotyping Real-Time PCR Kit and direct-sequencing. *BioMed Research International Vol. 2013, Pages 4, Jan 2013 SNPs Concordance(%) Sequencingvs. Real-Time PCR GG (n=11) GC (n=0) CC (n=0) GG (n=10) GA (n=0) AA (n=4) AA (n=4) GA (n=7) GG (n=0) 11 (100) (100) 1(100) 0 4(100) 7(100) 0 Diagnostic Evaluation and Correlation with Reference Method The clinical evaluation of the AccuPower TPMT genotyping Real-Time PCR Kit was performed on 246 clinical samples. AccuPower TPMT genotyping Real-Time PCR assay determined that 246 specimen results were 100% agreement with direct-sequencing method (Table 1). Automatic Analysis of TPMT *2, *3A, *3C SNPs ExiGenotyper software automatically interprets TPMT SNP results in real-time. TPMT SNP genotypes are analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure 1). Figure1. Example of AccuPower TPMT genotyping Real-Time PCR Kit result. Cat. no. Kit name Tests K-4411 ExiPrep Dx Blood Genomic DNA Kit

36 B-10. Human Genotyping AccuPower MTHFR Real-Time PCR Kit AccuPower MTHFR (C677T, A1298C) Real-Time PCR Kit MTHFR is an enzyme that converts 5, 10-methylenetetrahydrofolate to 5-methyltetrahydrofolate, a substrate for homocysteine remethylation to methionine. If MTHFR enzyme activity is reduced, methionine synthesis metabolism is inhibited and homocysteine concentration is increased (hyperhomocysteinemia), which may result in vascular disease and venous thromboembolism. MTHFR enzyme activity is reported to be related to SNPs of the MTHFR gene (677C>T, 1298A>C). AccuPower MTHFR Real-Time PCR Kit is designed to determine the genotype of MTHFR SNPs and configured for use with Exicycler 96 (ExiGenotyper software). MHR-1111 PCR premix (24rxn) MTH-1111 PCR premix (48rxn) Common components: PCs (W/M), DEPC D.W., Optical sealing film Target - Human MTHFR gene SNPs Sample type - Human whole blood, Human buccal swab Instrument - Exicycler 96 (ExiGenotyper software) The AccuPower MTHFR/ MTHFR (C677T, A1298C) Real- Time PCR Kit provides; Distinct and direct detection of MTHFR SNP genotype through allele-specific PCR method Highly sensitive detection of MTHFR SNP - The LoD is 10 ng/test - Detectable range is 10 ~ 200 ng/test No interference observed in the presence of the interfering substances such as EDTA, hemoglobin, albumin, cholesterol, etc. Table1. Comparison test results of AccuPower MTHFR Real-Time PCR Kit and direct-sequencing on clinical samples. SNPs 677 C>T Concordance (%) Sequencing ExiGenotyper CC (n=5) CT (n=6) TT (n=1) 5 (100) 6 (100) 1 (100) SNPs 1298 A>C Concordance (%) Sequencing ExiGenotyper AA (n=8) AC (n=3) CC (n=1) 8 (100) 3 (100) 1 (100) Diagnostic Evaluation and Correlation with Reference Method The clinical evaluation of the AccuPower MTHFR/MTHFR (C677T, A1298C) Real-Time PCR Kit was performed on 12 clinical samples. AccuPower MTHFR /MTHFR (C677T, A1298C) Real-Time PCR Kit determined that 12 specimen results were 100% agreement with directsequencing method. MTHFR 677/1298 conventional PCR kit of A company showed few false-genotyping results compared with directsequencing (Table 1). Automatic Analysis of MTHFR gene SNPs ExiGenotyper software automatically interprets MTHFR SNP results in real-time. MTHFR SNP genotype(s) are analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure 1). Figure 1. Example of AccuPower MTHFR (C677T, A1298C) Real-Time PCR Kit result BIONEER Cat. no. Kit name Tests K-4411 ExiPrep Dx Blood Genomic DNA Kit 96 36

37 B-10. Human Genotyping AccuPower JAK2 V617F Quantitative PCR Kit The JAK2 (Janus Kinase 2) gene has been reported to be related to MPD (Myeloproliferative Disorder). Studies has revealed that 90% mutation ratio of JAK2 V617F is found in PV (Polycythemia Vera) patients, 35%-70% mutation ratio in ET (Essential Thrombocythemia) patients, and 50% mutation ratio in Myelofibrisis patients. AccuPower JAK2 V617F Quantitative PCR Kit is designed for the quantification of each JAK2 wild type and mutant type to determine the mutant ratio. The kit is configured for use with Exicycler 96 (ExiGenotyper software). Target - Human JAK2 gene V617F SNP Sample type - Human whole blood, Human buccal swab Instrument - Exicycler 96 (ExiGenotyper software) JAK-1111 PCR premix (48rxn), SPCs (Wild type/mutant) DEPC D.W., Optical sealing film The AccuPower JAK2 V617F Quantitative PCR Kit provides; Reliable quantification of JAK2 SNP through allele-specific PCR method Highly sensitive detection of JAK2 SNP - The LoD is 1 ng/test (mutation ratio 0.01%) - Detectable range is 1 ~ 200 ng/test No interference observed in the presence of the interfering substances such as EDTA, hemoglobin, albumin, cholesterol, etc. Figure 1. Comparison test results of AccuPower JAK2 V617F Quantitative PCR Kit and direct-sequencing on clinical samples. Diagnostic Evaluation and Correlation with Reference Method The clinical evaluation of the AccuPower JAK2 V617F Quantitative PCR Kit was performed on 10 clinical samples. AccuPower JAK2 V617F quantification determined that 10 specimen results were 95% agreement with direct-sequencing method (Figure 1). Automatic Analysis of JAK2 V617F Mutation Ratio ExiGenotyper software automatically analyzes JAK2 V617F mutation ratio in real-time. The mutation ratio is analyzed based on the quantified each allele specific amplification result(figure 2). The detectable limit of JAK2 mutation ratio is 0.01%. Figure 2. Example of AccuPower JAK2 V617F Quantitative PCR Kit result Cat. no. Kit name Tests K-4411 ExiPrep Dx Blood Genomic DNA Kit

38 B-10. Human Genotyping AccuPower Factor V Leiden Real-Time PCR Kit Factor V Leiden thrombophilia is characterized by a poor anticoagulant response to activated protein C (APC). The term Factor V Leiden refers to the specific G-to-A substitution at nucleotide 1691 of the gene for Factor V to result in a single amino acid replacement (R506Q) at one of three APC cleavage sites in the factor V molecule. AccuPower Factor V Leiden Real-Time PCR Kit is designed to determine the genotype of Factor V SNP and configured for use with Exicycler 96 (ExiGenotyper software). Target - Human Factor V gene SNP (1691 G>A) Sample type - Human whole blood, Human buccal swab Instrument - Exicycler 96 (ExiGenotyper software) FVL-1111 PCR premix (48rxn), PCs (W/M), DEPC D.W., Optical sealing film The AccuPower Factor V Leiden Real-Time PCR Kit provides; Distinct and direct detection of Factor V SNP genotype through allele-specific PCR method Highly sensitive detection of Factor V SNP - The LoD is 1 ng/test - Detectable range is 1 ~ 200 ng/test No interference observed in the presence of the interfering substances such as EDTA, hemoglobin, albumin, cholesterol, etc. Table 1. Comparison test results of AccuPower Factor V Leiden Real-Time PCR Kit and direct-sequencing on clinical samples. Bioneer Factor V Leiden Direct-sequencing Method Wild type Heterozygous Mutant Total Wild type Heterozygous Mutant Total Diagnostic Evaluation and Correlation with Reference Method The clinical evaluation of the AccuPower Factor V Leiden Real-Time PCR Kit was performed on 12 clinical samples. AccuPower Factor V Leiden Real-Time PCR kit determined that 12 specimen results were 100% agreement with direct-sequencing method (Table 1). Automatic Analysis of Factor V SNP ExiGenotyper software automatically analyzes Factor V SNP results in real-time. Factor V SNP genotype is analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure 1). Figure 1. Example of AccuPower Factor V Leiden Real-Time PCR Kit result Cat. no. Kit name Tests K-4411 ExiPrep Dx Blood Genomic DNA Kit 96 BIONEER 38

39 B-11. Chronic Myelogenous Leukemia AccuPower BCR-ABL Quantitative RT-PCR Kit Philadelphia chromosome or Philadelphia translocation is a specific chromosomal abnormality that is associated with chronic myelogenous leukemia (CML). It is the result of a reciprocal translocation between chromosome 9 (region q34: ABL) and 22 (region q11: BCR). ABL gene expresses a membrane-associated protein, a tyrosine kinase, the BCR-ABL transcript is also translated into a tyrosine kinase, adding a phosphate group to tyrosine. In turn, BCR-ABL activates a number of cell cyclecontrolling proteins and enzymes, speeding up cell division. Moreover, it inhibits DNA repair, causing genomic instability and potentially causing the feared blast crisis in CML. The AccuPower BCR-ABL Quantitative RT-PCR Kit is an in vitro diagnostic kit designed for the quantification of BCR-ABL mutation in human whole blood samples through Real-Time polymerase chain reaction (PCR) using Exicycler 96 MDx System. CML-1111 BCR-ABL PCR premix (48 rxn), ABL PCR premix (48 rxn), SPCs (S1~S5), Optical sealing film Target - ABL (reference gene), BCR-ABL(M-bcr) -b3a2, b2a2 Sample type - Human whole blood Instrument - Exicycler 96 The AccuPower BCR-ABL Quantitative RT-PCR Kit provides; Highly sensitive detection of M-bcr (b3a2, b2a2) mutation ratio (Figure 2) - 5 log detection One-Step Real-Time RT-PCR reaction using Dual-HotStart technology Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower BCR- ABL Quantitative RT-PCR Kit Left figure: ABL, Right figure : M-bcr Figure 2. Analytical sensitivity of AccuPower BCR-ABL Quantitative RT-PCR Kit 39

40 B-12. Mosquito-borne Diseases AccuPower ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit Infection of Zika(ZIKV), Dengue(DENV) and Chikungunya(CHIKV) viruses are referred to as mosquito-borne diseases since they are transmitted by mosquitoes. Over one million people die from these diseases every year. ZIKV, DENV and CHIKV have similar symptoms and a common vector, Aedes aegypti. Especially, the risk of microcephaly is increased in newborn baby borned from mother who had ZIKV infection. Therefore simultaneous diagnosis of these viruses is important. The AccuPower ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for qualification of ZIKV, DENV and CHIKV RNA simultaneously in human samples, such as serum and plasma samples, through Real-Time polymerase chain reaction (RT-PCR). ZIK-1111 PCR premix(96rxn), PC, IPC, NTC, DEPC D.W., Optical sealing film Target - Zika, Dengue and Chikungunya virus RNA Sample type - Serum, Plasma (for ZIKV,DENV and CHIKV), Urine (for ZIKV only) Instrument - Exicycler 96, ExiStation The AccuPower ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit provides; Multiplex detection of ZIKV, DENV and CHIKV in a tube Highly sensitive detection of each viruses - LoD of ZIKV : copies/ml - LoD of DENV : copies/ml - LoD of CHIKV : copies/ml Specific one-step Real-Time RT-PCR reaction using Dual-HotStart technology No interference observed in the presence of the interfering substances Figure 1. Detection of ZIKV,DENV and CHIKV Positive Control using Exicycler 96 Green signal: ZIKV, Black signal : DENV, Red signal : CHIKV, Yellow signal IPC Cat. no. Kit name Instrument Tests ZIK-1111 AccuPower ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit Exicycler ZIK-1112 AccuPower ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit ABI7500, CFX K-4471 ExiPrep Dx Viral DNA/RNA kit 96 K-4473 ExiPrep Dx Viral RNA kit 96 BIONEER 40

41 References Category Reference Journal HBV Comparison of MagNA Pure 96, Chemagic MSM1, and QIAamp MinElute for Hepatitis B Virus Nucleic Acid Extraction Annals of Clinical & Laboratory Science HBV Performance evaluation of ExiStation HBV diagnostic system forhepatitis B virus DNA quantitation Journal Of Virological Methods BCI Blood Screening An evaluation of the Bioneer s multiplex AccuPower BCI blood screening kit Vox Sanguinis HLA Evaluation of Two Commercial HLA-B27 Real-Time PCR Kits Korean Journal of Laboratory Medicine IFA Clinical Characteristics and Comparison of the Various Methods Used for the Diagnosis of the New Influenza A Pandemic in Korea Laboratory Medicine Online IFA Evaluation of Direct Immunofluorescence Test with PCR for Detection of Novel Influenza A (H1N1) Virus during 2009 Pandemic Yonsei Medical Journal cal Journal IFA Characteristics of Hospitalized Children with 2009 Pandemic Influenza A (H1N1): A Multicenter Study in Korea Journal Of Korean Medical Science IFA Positive Rates of 2009 Novel Influenza A (H1N1) was High in School-Aged Individuals: Significance in Pandemic Control Journal Of Korean Medical Science MAL A novel real-time PCR assay for the detection of Plasmodium falciparum and Plasmodium vivax malaria in low parasitized individuals Acta Tropica MAL A Case of Plasmodium ovale Malaria Imported from West Africa Korean Journal Of Parasitology MP Macrolide Resistance of Mycoplasma pneumoniae and Its Detection Rate by Real-Time PCR in Primary and Tertiary Care Hospitals Ann Lab Med MP Two Cases of Mycoplasma pneumoniae Pneumonia with A2063G Mutation in the 23S rrna Gene in Siblings Ann Lab Med MTB Proportion of Multidrug-Resistant Tuberculosis in Human Immunodeficiency Virus/Mycobacterium tuberculosis Co-Infected Patients in Korea Journal Of Korean Medical Science MTB Comparison of 14 Molecular Assays for Detection of Mycobacterium tuberculosis Complex in Bronchoalveolar Lavage Fluid Journal of Clinical Microbiology NOR Evaluation of a New Immunochromatographic Assay Kit for the Rapid Detection of Norovirus in Fecal Specimens Ann Lab Med NOR Updates on the genetic variations of Norovirus in sporadic gastroenteritis in Chungnam Korea, Virology Journal NOR STI Evaluation of a new real-time reverse transcription polymerase chain reaction assay for detection of norovirus in fecal specimens Prevalence and Associated Factors for Four Sexually Transmissible Microorganisms in Middle-Aged Men Receiving General Prostate Health Checkups: A Polymerase Chain Reaction-Based Study in Korea Diagnostic Microbiology and Infectious Disease Korean Journal of Urology TPMT Validation of New Allele-Specific Real-Time PCR System for Thiopurine Methyltransferase Genotyping in Korean Population BioMed Research International WAF New allele-specific real-time PCR system for warfarin dose genotyping equipped with an automatic interpretative function that allows rapid, accurate, and userfriendly reporting in clinical laboratories Thrombosis Research 41

42 BIONEER 42

43 ExiPrep Dx Nucleic Acid Extraction Kits 44 C-1. Viral DNA/RNA Kit 46 C-2. Blood Viral DNA Kit 46 C-3. Bacteria Genomic DNA Kit 47 C-4. Mycobacteria Genomic DNA Kit 47 C-5. Blood Genomic DNA Kit 48

44 ExiPrep Dx Nucleic Acid Extraction Kits ExiPrep Dx Nucleic Acid Extraction Kits Success in molecular diagnostic detection and analysis requires effective method in the nucleic acid extraction from various sample types. For that, ExiPrep Dx Nucleic Acid Extraction Kit series provide a convenient and efficient method for the isolation and purification of nucleic acids from a variety of samples including blood, urine, sputum, BAL and respiratory swabs so on. Based on this, Bioneer s kits offer various isolation systems for special testing purpose, assuring highquality nucleic acid purification. Features Using the automated clinical nucleic acid extraction instrument ExiPrep 16 Dx Target nucleic acids can be extracted from 1 to 16 samples simultaneously Optimized protocols for nucleic acid extraction according to sample types are pre-installed for reproducible results ExiPrep 16 Dx system use silica magnetic beads developed and produced with Bioneer s technology Workflow BIONEER 44

45 ExiPrep Dx Nucleic Acid Extraction Kits Kit Components Buffer cartridge 1 6ea Buffer cartridge 2 6ea Disposable filter tip (32 ea) 3 packs Elution tube (12ea) 1 pack & Contamination shield filter paper (12ea) 1 pack Protection cover (3ea) 4 packs Waste tray (3ea) 1 pack Sample loading tube 6 packs EZ Solution EZ Solution is easy sputum liquefying solution containing strong reducing agent. The sputum pretreatment process using EZ Solution doesn t require time consuming centrifuging and washing steps. This innovation make the sputum treatment simpler, faster and even more effective compared to the method using NaOH. Selection Guide Diagnostic Kits Related nucleic acid prep kits ExiPrep Dx Viral DNA/RNA ExiPrep Dx Viral DNA ExiPrep Dx Viral RNA ExiPrep Dx Blood Viral DNA ExiPrep Dx Bacterial Genomic DNA ExiPrep Dx Mycobacteria Genomic DNA ExiPrep Dx Blood Genomic DNA AccuPower HIV-1 Quantitative RT-PCR Kit AccuPower HBV Quantitative PCR Kit AccuPower HCV Quantitative RT-PCR Kit AccuPower BCI Blood screening Kit AccuPower TB related Real-Time PCR Kits AccuPower STI related Real-Time PCR Kits AccuPower HSV type1 & type2 Real-Time PCR Kit AccuPower HPV 16&18 Real-Time PCR Kit AccuPower Influenza A Real-Time RT-PCR Kits AccuPower CP Real-Time PCR Kit AccuPower MP Real-Time PCR Kit AccuPower MERS-CoV Real-Time RT-PCR Kit AccuPower MERS-CoV (upe&orf1a) Real-Time RT-PCR Kit AccuPower Gastrointestinal Pathogen Real-Time RT-PCR Kit AccuPower CMV Quantitative PCR Kit AccuPower EBV Quantitative PCR Kit AccuPower BKV Quantitative PCR Kit AccuPower ZIKV(DENV,CHIKV) Multiplex Real-Time RT-PCR Kit AccuPower Genotyping Real-Time PCR Kits 45

46 C-1. ExiPrep Dx Viral DNA/RNA Kit ExiPrep Dx Nucleic Acid Extraction Kits ExiPrep Dx Viral DNA/RNA Kit ExiPrep Dx Viral DNA/RNA Kit is designed for the high-yield extraction of viral DNA or RNA in clinical samples using the ExiPrep 16 Dx. Experimental Data Figure 1. Quantification of HBV viral load was performed to evaluate ExiPrep Dx Viral DNA Kit. Viral DNA was extracted from serum using the kit, and Real-Time PCR was performed with the AccuPower HBV Quantitative PCR Kit on Exicycler 96 (Black signal; HBV, Blue signal; IPC). Figure 2. Quantification of HIV type 1 viral load was performed to evaluate ExiPrep Dx Viral RNA Kit. Viral RNA was extracted from serum using the kit, and Real- Time PCR was performed with the AccuPower HIV-1 Quantitative RT-PCR Kit on Exicycler 96 (Black signal; HIV-1, Blue signal; IPC). Specifications Cat. no. Kit name Sample types Initial vol. Elution vol. K-4471 ExiPrep Dx Viral DNA/RNA Kit K-4472 ExiPrep Dx Viral DNA Kit K-4473 ExiPrep Dx Viral RNA Kit Serum, Plasma, Swab, Urine, Stool, CSF 400 ul 50 ul C-2. ExiPrep Dx Blood Viral DNA Kit ExiPrep Dx Blood Viral DNA Kit ExiPrep Dx Blood Viral DNA Kit is for the extraction of viral DNA from whole blood using the automated clinical nucleic acid extraction instrument ExiPrep 16 Dx. Specifications Nominal concentration N Bioneer Measured Concentration SD (Log IU/ml) A company Positive sample IU/ml IU/ml 5000 IU/ml IU/ml IU/ml 500 IU/ml IU/ml IU/ml 250 IU/ml IU/ml IU/ml 100 IU/ml IU/ml IU/ml BIONEER 46 Table 1. Quantification of EBV was performed to compare the efficiency of ExiPrep Dx Blood Viral DNA Kit with competitor kit. Specifications Figure 1. Serial dilutions of blood samples (5x10 3 ~ 5x10 7 copies/ml) containing EBV was processed according to the kit protocol. Cat. no. Sample types Initial vol. Elution vol. K-4474 Human whole blood 200 ul 50 ul

47 C-3. ExiPrep Dx Bacteria Genomic DNA Kit ExiPrep Dx Nucleic Acid Extraction Kits ExiPrep Dx Bacteria Genomic DNA Kit ExiPrep Dx Bacteria Genomic DNA Kit is designed for the high-yield extraction of bacteria DNA in clinical samples using the ExiPrep 16 Dx. Experimental Data ExiPrep Dx Bacteria Genomic DNA Kit Boiling Method Figure1. Detection of Ureaplasma urealyticum was performed to to compare the efficiency of ExiPrep Dx Bacteria Genomic DNA Kit with reference method, boiling preparation and Real-Time PCR was performed with the AccuPower UU Real-Time PCR Kit on Exicycler 96 (Black signal; UU, Blue signal; IPC). Specifications Cat. no. Sample types Initial vol. Elution vol. K-4414 Sputum, Urine, Swab 400 ul 50 ul C-4. ExiPrep Dx Mycobacteria Genomic DNA Kit ExiPrep Dx Mycobacteria Genomic DNA Kit ExiPrep Dx Mycobacteria Genomic DNA Kit is designed for the high-yield extraction of mycobacteria genomic DNA in clinical samples using the ExiPrep 16 Dx. EZ Solution, sputum liquefying solution, makes the DNA extraction easier and faster. EZ Solution vs NaOH: Sputum Pretreatment Figure 1. Sputum pretreatment procedure using EZ Solution and 1N NaOH. The process using EZ Solution is simpler, faster and even effective. No centrifuge, no washing steps are required. Specifications Cat. no. Sample types Initial vol. Elution vol. K-4418 Sputum, Urine, BAL 400 ul 50 ul 47

48 C-5. ExiPrep Dx Blood Genomic DNA Kit ExiPrep Dx Nucleic Acid Extraction Kits ExiPrep Dx Blood Genomic DNA Kit ExiPrep Dx Blood Genomic DNA Kit is for the extraction of human DNA from whole blood using the automated clinical nucleic acid extraction instrument ExiPrep 16 Dx. Experimental Data Figure 1. Results of gel electrophoresis run on Agaro-Power System (A-7020, Bioneer) and DNA concentration or purity estimation of genomic DNA extracted from human blood 200ul (A1, A2; A company, 1, 2, 3, 4, 5, 6; BIONEER). Figure 2. Genotyping of ApoE SNP was performed to compare the efficiency of ExiPrep Dx Blood Genomic DNA Kit with competitor kit. Genomic DNA was extracted from whole blood using the ExiPrep Dx Blood Genomic DNA Kit, and Real-Time PCR was performed with the AccuPower ApoE Real-Time PCR Kit on Exicycler 96. Specifications Cat. no. Sample types Initial vol. Elution vol. K-4411 Human whole blood 200 ul 70 ul BIONEER 48

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