"Faster, Easier and more Reliable"

Transcription

1 "Faster, Easier and more Reliable" Infopia, having developed biosensors for blood diagnosis since its establishment in 1996, is now exporting state-of-the-art biosensors for monitoring blood glucose and measuring HbA1c and cholesterol to about 110 countries around the world. We not only have the goal to be the best company in diagnostic bio distribution through developing sensors for diagnosing heart disease and cancers and remote diagnosing systems, etc., but also plan to drive business through maintaining human health more directly through healthcare services. 1

2 SelexOn TM Product List Class Items Description Blood Volume Measurement Time Measurement Range Certification Page METER CARDIAC SelexOn Meter SelexOn Myoglobin Cardiovascular diseases SelexOn D-dimer Thrombosis SelexOn CK-MB Cardiovascular diseases SelexOn Troponin I Cardiovascular diseases SelexOn hs-crp Cardiovascular diseases 10 ul SelexOn BNP Cardiovascular diseases 6 10 Min 50.00~ ng/ml < 100 ng/ml kfda, CE 7 10 Min ~3, ng/ml < 500 ng/ml kfda, CE 8 10 Min 3.00~40.00 ng/ml < 7 ng/ml kfda, CE 9 10 Min 0.30~10.00 ng/ml < 0.5 ng/ml kfda, CE Min 0.50~10.00 mg/l < 3 mg/l kfda, CE Min 0.05~2.00 ng/ml < 0.1 ng/ml kfda, CE 12 SelexOn Triple (CK-MB, Myoglobin, Troponin I) Cardiovascular diseases 250 ul 10 Min Same with Myoglobin, Troponin I and CK-MB kfda, CE 13 CANCER THYROID SelexOn AFP Liver cancer SelexOn CEA Colorectal cancer SelexOn PSA Prostate cancer SelexOn Free PSA Prostate cancer SelexOn TSH Thyroid disease SelexOn T3 Thyroid disease SelexOn T4 Thyroid disease 10 Min 5.00~50.00 ng/ml < 10 ng/ml kfda, CE Min 1.00~30.00 ng/ml < 7 ng/ml kfda, CE Min 2.00~30.00 ng/ml < 4 ng/ml kfda, CE Min 0.50~10.00 ng/ml < 1 ng/ml CE Min 0.20~50.00 miu/l < 0.5 miu/l : hyperthyroidism 0.5 ~ 5 miu/l : normal > 5 miu/l : hypothyroidism kfda, CE Min 0.50~5.00 ng/ml 0.8 ~ 1.7 ng/ml To be launched soon Min 3.00~20.00 ug/dl 4.5 ~ 12 ug/dl kfda, CE 20 SelexOn Ag P.f disease 5 ul 20 Min 21 SelexOn Ag P.v disease 5 ul SelexOn Ag P.f / P.v disease 5 ul 20 Min CE Min 23 SelexOn disease 5 ul 20 Min 24 INFECTION SelexOn HBsAg Hepatitis B virus SelexOn Anti-HBs Hepatitis B virus (only plasma, serum) SelexOn HCV Hepatitis C virus 50 ul SelexOn Dengue NS1 Ag Dengue fever SelexOn HIV 1/2 Human immunodeficiency virus 20 ul 20 Min or Min Min Min Min To be launched soon 29 SelexOn CRP Inflammation 5 ul 10 Min 5.00~ mg/l < 10 mg/l 30 Diabetes SelexOn C-peptide Diabetes mellitus SelexOn Insulin Diabetes mellitus 10 Min 0.20~15.00 ng/ml Normal fasting blood : 0.5~2.2 ng/ml 10 Min 10.00~ miu/l < 30 miu/l Other SelexOn Vitamin D 10 Min 10.00~70.00 ng/ml Deficient : <20 ng/ml Insufficient : 20~29 ng/ml Sufficient : 30 ng/ml 33 3

3 The introduction of SelexOn System SelexOn is a POCT diagnostic system utilizing chromatographic immunoassay between antigen and antibody to quantitatively determine the concentration of various bio-markers in human blood. It optimized for the screening of major Life-style related diseases including, but not limited to, cardiac disease, cancer, thyroid disease and infection disease. s (Selection) Patient Test(=Normal Test) Mode - Directly apply the specimen on the strip - One strip test within 10 minutes Quick Test Mode - Apply specimen to strips outside of Meter - Insert each strip into the device after reaction time Patient s Symptom Generated biomarker Each marker moves through the patient s blood SelexOn TM Diagnose by immune reaction in collecting patient s blood Touch the screen of Patient test mode 1 1 Apply the sample to various strip outside the meter Myglobin D-dimer CK-MB HBsAg By the immunoassay 2 Insert the strip 2 Touch the screen of Quick test mode and wait during the detection time Principle The lateral flow immunoassay is known as a sandwich assay. In this quantitative or qualitative measurement method, by using an antigen, a gold nanoparticle-labelled detection antibody is combined with an antibody specific to disease markers. The antigen concentration within blood appears as the thickness of the red band on the test line. 3 Apply the sample and touch the OK 3 Insert the strip after detection time Sample migrates from the sample pad through the conjugate pad where any target analyte present will bind to the conjugate. The sample continues to migrate across the membrane until it reaches the capture zone where the target/ conjugate complex will bind to the immobilized antibodies producing a visible line on the nitrocellulose membrane. The optical system of the SelexOn meter detects the two lines and measures the intensity of the signal line. The integrated software converts the signal intensity to a quantitative result and shows it on the display. 4 Obtain test result () 4 Obtain test result and press "Continue" 5 Insert the next strip Features Repeat Simple & Small Convenient Usability Fully portable device Minimizing buttons by applying touch screen Available to store test strips at room temperature Testing numerous markers simultaneously trough Quick test 6 Obtain test result and press "Continue" Accurate & Fast Easy Recognition 4 Quantitative result in 10 minutes Available to add markers only RFID tagging Automatic update of strip information 5

4 SelexOn System Description Cardiovascular Diseases SelexOn Myoglobin Meter Strip Insertion Port Touch Screen LCD Single Strip Strip Code Blood inlet area Measuring Window Strip Handle Myoglobin is a tightly folded, globular heme-protein located in the cytoplasm of both skeletal and cardiac muscle cells. Blood concentrations of myoglobin increase above the reference range within the first two hours following injury, reaching a peak between six and eight hours after the onset of symptoms. Myoglobin returns to baseline or normal concentrations within hours after tissue damage. Blood myoglobin concentrations may be elevated as a result of a variety of conditions that produce muscle damage. These include trauma, ischemia, surgery, exercise and a variety of degenerative muscular diseases. The SelexOn Myoglobin test strip quantitatively measures myoglobin concentration in human blood. Triple Strip Blood Inlet RFID Reader Power Button Power LED (Top) Charging LED (Bottom) Fan Filter Cover ng/ml ~ ng/ml 100 ng/ml General Information Sample Type / Volume test mode Multi-measurement Add markers Memory Power Source Battery(Option) Dimensions / Weight -treated (EDTA-treated) venous whole blood Normal test - / 1test, Quick test - Maximum 100 tests / hour Simultaneous measurement of various item using Quick Test Mode Only RFID register without modifying program 1000 results DC 9V / 3A Measured during the 5 hours of battery power only Meter 168 x 190 x 95 (mm) / 0.8 kg, Strip 30 x 98 x 6 (mm) / 8.7 g Mean ng/ml ng/ml SD (Standard Deviation) 3.03 ng/ml ng/ml CV (Coefficient Variation) 5.5% 5.5% Temperature Operational Temperature Meter 10 ~ 35 C (50 ~ 95 F), Strip 2 ~ 30 C (36 ~ 86 F) 18 ~ 32 C (64 ~ 90 F) 1 Insert strip and inject whole blood Humidity 10 ~ 85% Peripheral Device Easy to input patient and operator ID Thermal Printer, Barcode Scanner, Battery (8.4V / 4400mAh), Data Cable by touch key pad, barcode reader a Easy to use graphical user interface(gui) and touch 6 Cat. No. INFI01A Item SelexOn Meter Cat. No. Item Pack size INFIM01A SelexOn Myoglobin Whole blood (venous) 20 test/box 7

5 Cardiovascular Diseases SelexOn D-dimer Cardiovascular Diseases SelexOn CK-MB The process of blood coagulation results in the conversion of fibrinogen into fibrin by thrombin and subsequent fibrin polymerization. The fibrin clot is then digested by plasmin and fibrin degradation products with different molecular weights are released into the blood stream. D-dimer is a soluble fibrin degradation product released when cross-linked fibrin is degraded by plasmin. D-dimer is a coagulation marker that is elevated in several clinical conditions. D-dimer has gained widespread clinical use as a parameter for detection of breakdown of in-vivo fibrin formation. D-dimer testing is of clinical use when there is a suspicion of deep venous thrombosis (DVT), pulmonary embolism (PE) or disseminated intravascular coagulation (DIC). The SelexOn D-dimer test strip quantitatively measures D-dimer concentration in human blood. Creatine kinase MB (CK-MB) is an 82,000 Dalton cytosolic enzyme that is present in high concentrations in the myocardium. Typically, CK-MB increases above normal within the first four to eight hours following Acute Myocardial Infarction(AMI), reaching maximum concentrations between 12 and 24 hours and returning to normal in approximately three days. Blood concentrations of CK- MB can be elevated as a result of acute or chronic muscle damage, including strenuous exercise and trauma. Nonetheless, measurements of blood CK-MB concentrations are widely relied on for the management of patients having an AMI. The SelexOn CK-MB test strip quantitatively measures CK-MB concentration in human blood ng/ml ~ ng/ml 3.00 ng/ml ~ ng/ml 500 ng/ml 7 ng/ml Mean ng/ml ng/ml SD (Standard Deviation) ng/ml ng/ml CV (Coefficient Variation) 8.2% 8.7 % Mean 5.73 ng/ml ng/ml SD (Standard Deviation) 0.33 ng/ml 1.35 ng/ml CV (Coefficient Variation) 5.8% 5.7% 1 Insert strip and inject whole blood 1 Insert strip and inject whole blood 8 Cat. No. Item Pack size INFID01A SelexOn D-dimer Whole blood (venous) 20 test/box Cat. No. Item Pack size INFIC01A SelexOn CK-MB Whole blood (venous) 20 test/box 9

6 Cardiovascular Diseases SelexOn Troponin I Cardiovascular Diseases SelexOn hs-crp Troponin I is a regulatory subunit of the protein complex associated with the actin thin filament within muscle cells. Cardiac troponin I is currently the most sensitive and specific biochemical markers of acute myocardial infarctions (AMI). Elevated levels of cardiac troponin I are detectable in serum within 4 to 6 hours after the onset of chest pain, reach peak concentrations in approximately 8 to 28 hours, and remain elevated for 3 to 10 days following AMI. Since troponin I is well known to be an important prognostic indicator of heart disease, its most definitive role is on monitoring posttreatment clinical status and the post therapeutic evaluation of patients. The SelexOn Troponin I test strip quantitatively measures troponin I concentration in human blood. C-reactive protein (CRP) is an acute-phase protein synthesized by the liver in response to cytokine production (IL-6, IL-1, tumor necrosis factor) during tissue injury, rheumatic and other inflammation, or infection. According to the CRP properties, they used to bio-marker for physiological inflammation reaction. Recent studies have shown that CRP, especially high sensitive CRP (hs-crp), can be an indicator of risk of cardiovascular disease in apparently healthy people. That is elevations of CRP within the normal reference range are associated with an increased risk for cardiovascular disease. The SelexOn hs-crp test strip quantitatively measures CRP concentration in human whole blood ng/ml ~ ng/ml 0.5 ng/ml Mean 0.38 ng/ml 3.42 ng/ml SD (Standard Deviation) 0.03 ng/ml 0.33 ng/ml CV (Coefficient Variation) 7.2% 9.7% 0.50 mg/l ~ mg/l 3 mg/l 10 ul sample from dilution mixture Dilution tube Mean 2.21 mg/l 6.60 mg/l SD (Standard Deviation) 0.15 mg/l 0.41 mg/l CV (Coefficient Variation) 7.0% 6.2% 1 Apply the 10ul venous whole blood to the dilution tube and then mix well. 2 Insert strip and inject 100ul sample from the dilution tube 3 Touch <OK> button. 4 After 10 min, 1 Insert strip and inject whole blood 10 Cat. No. Item Pack size INFIO01A SelexOn Troponin I Whole blood (venous) 20 test/box Cat. No. Item Pack size INFIH01A SelexOn hs-crp Whole blood (venous) 20 test/box 11

7 Cardiovascular Diseases SelexOn BNP Cardiovascular Diseases SelexOn Triple Brain natriuretic peptide (BNP) is a peptide hormone and belongs to a family of structurally similar peptide hormones. BNP and N-terminal part of the probnp (NT-proBNP) are the product of proteolytic processing of the precursor molecule preprobnp. Elevated level of BNP and NT-proBNP is described for patients with different cardiovascular pathologies such as heart failure (HF), left ventricular dysfunction, unstable angina and myocardial infarction. Cardiac patients with symptoms of severe HF and myocardial dysfunction show significantly increased values of BNP. Therefore BNP and NT-proBNP measurements in human blood are used for evaluation of patients with suspected HF and assessment of severity of the disease. The SelexOn BNP test strip quantitatively measures BNP concentration in human blood. The SelexOn Triple test strip measure 3 items (Myoglobin, CK-MB and Troponin I) as the cardiac markers, at a time. Blood concentrations of Myoglobin may be elevated as a result of a variety of conditions that produce muscle damage. Blood concentrations of CK-MB can be elevated as a result of acute or chronic muscle damage, including strenuous exercise and trauma. The concentration of Troponin I increases in several malignant diseases, mostly primary coronary syndrome, myocardial injury and infarction. Troponin I is a more powerful prognostic marker in people with ischemic chest pain than CK-MB and significant increases in serum. The SelexOn Triple test strip quantitatively measures Myoglobin, CK-MB and Troponin I concentration in human blood. Myoglobin (50.0 ng/ml ~ ng/ml) CK-MB (3.0 ng/ml ~ 40.0 ng/ml) 250 ul 0.05 ng/ml ~ 2.00 ng/ml 0.1 ng/ml Troponin I (0.3 ng/ml ~ 10.0 ng/ml) Myoglobin (100.0 ng/ml) CK-MB (7 ng/ml) Troponin I (0.5 ng/ml) Mean 0.07 ng/ml 1.61 ng/ml SD (Standard Deviation) 0.01 ng/ml 0.15 ng/ml CV (Coefficient Variation) 13.2% 9.3% 1 Insert strip and inject whole blood Myoglobin CK-MB Troponin I 1 Insert strip and inject 250 ul whole blood Mean ng/ml ng/ml SD (Standard Deviation) 3.63 ng/ml ng/ml CV (Coefficient Variation) 6.5% 6.7% Mean 6.64 ng/ml ng/ml SD (Standard Deviation) 0.64 ng/ml 1.87 ng/ml CV (Coefficient Variation) 9.7% 7.0% Mean 0.47 ng/ml 4.42 ng/ml SD (Standard Deviation) 0.05 ng/ml 0.32 ng/ml CV (Coefficient Variation) 9.6% 7.3% 12 Cat. No. Item Pack size INFIQ01A SelexOn BNP Whole blood (venous) 20 test/box Cat. No. Item Pack size INFIR01A SelexOn Triple Whole blood (venous) 20 test/box 13

8 Liver Cancer SelexOn AFP Colorectal Cancer SelexOn CEA Alpha Fetoprotein (AFP) is a single-chain glycoprotein with a molecular weight of approximately 70 kda. AFP is synthesized primarily in the liver and yolk sac of the fetus. The human fetus has the highest amount AFP levels found in human. AFP is measured in pregnant women through the analysis of maternal blood or amniotic fluid, as a screening test for a subset of developmental abnormalities. It can also be used as a biomarker to detect a subset of tumors in non-pregnant women, men, and children. Elevation of AFP is used as one factor in the diagnosis of ataxia telangiectasia. The SelexOn AFP test strip quantitatively measures AFP concentration in human blood. Carcinoembryonic antigen(cea) is an oncofetal glycoprotein, which is found at high levels in the fetal colon and at lower levels in the normal adult colonic epithelium. CEA occurs at abnormally high levels in several benign disorders and in some malignant tumors, including those of the stomach, small intestine, colon, rectum, pancreas, liver, breast, ovary, cervix and lung. Levels of CEA are significantly lower in colon tissue of adults, but can become elevated when inflammation or tumors arise in any endodermal tissue, including in the gastrointestinal tract, respiratory tract, pancreas and breast. The SelexOn CEA test strip quantitatively measures CEA concentration in human blood ng/ml ~ ng/ml 1.00 ng/ml ~ ng/ml 10 ng/ml 7 ng/ml Mean 9.87 ng/ml ng/ml SD (Standard Deviation) 0.55 ng/ml 1.29 ng/ml CV (Coefficient Variation) 5.6% 5.9% Mean 2.41 ng/ml ng/ml SD (Standard Deviation) 0.27 ng/ml 1.63 ng/ml CV (Coefficient Variation) 11.1% 10.1% 1 Insert strip and inject whole blood 1 Insert strip and inject whole blood 14 Cat. No. Item Pack size INFIA01A SelexOn AFP Whole blood (venous) 20 test/box Cat. No. Item Pack size INFIE01A SelexOn CEA Whole blood (venous) 20 test/box 15

9 Prostate Cancer SelexOn PSA Prostate Cancer SelexOn Free PSA Prostate specific antigen (PSA) is a neutral serine protease with chymotrypsin-like activity. PSA is synthesized by the glandular epithelium of the prostate and is benign. Hyperplasic and malignant prostate tissue, in metastatic prostate carcinoma, in prostate fluid, and seminal plasma. Low levels of PSA are found in the blood of normal males as a result of antigen leakage from the prostate gland into blood circulation. The elevated levels of PSA in the blood are associated with prostate pathology, including prostatitis, benign prostatic hyperplasia (BPH), and prostate cancer. The SelexOn PSA test strip quantitatively measures PSA concentration in human blood. PSA is synthesized by the glandular epithelium of the prostate and is benign. Hyperplasic and malignant prostate tissue, in metastatic prostate carcinoma, in prostate fluid, and seminal plasma. Low levels of PSA are found in the blood of normal males as a result of antigen leakage from the prostate gland into blood circulation. The elevated levels of PSA in the blood are associated with prostate pathology, including prostatitis, benign prostatic hyperplasia (BPH), and prostate cancer. Most PSA in the blood is bound to serum proteins. A small amount is not protein bound and is called 'free PSA'. In men with prostate cancer the ratio of free (unbound) PSA to total PSA is decreased. The risk of cancer increases if the free to total ratio is less than 25%. The lower the ratio is, the greater the probability of prostate cancer. The SelexOn Free PSA test strip quantitatively measures free PSA concentration in human blood ng/ml ~ ng/ml 0.50 ng/ml ~ ng/ml 4 ng/ml 1 ng/ml Mean 2.46 ng/ml ng/ml SD (Standard Deviation) 0.17 ng/ml 1.11 ng/ml CV (Coefficient Variation) 6.9% 7.4% Mean 0.66 ng/ml 8.11 ng/ml SD (Standard Deviation) 0.09 ng/ml 0.75 ng/ml CV (Coefficient Variation) 13.1% 9.2% 1 Insert strip and inject whole blood 1 Insert strip and inject whole blood 16 Cat. No. Item Pack size INFIP01A SelexOn PSA Whole blood (venous) 20 test/box Cat. No. Item Pack size INFIU01A SelexOn Free PSA Whole blood (venous) 20 test/box 17

10 Thyroid diseases SelexOn TSH Thyroid diseases SelexOn T3 Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone. Iodine deficiency is often cited as the most common cause of hypothyroidism worldwide but it can be caused by many other factors. Hyperthyroidism often referred to as an 'overactive thyroid' is when the thyroid gland produces and secretes excessive amounts of the thyroid hormones triiodothyronine (T3) and/or free thyroxine (T4). This is the opposite of hypothyroidism ('sluggish thyroid'), which is the reduced production and secretion of T3 and/or T4. The SelexOn TSH test strip quantitatively measures TSH concentration in human blood. The thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are tyrosine-based hormones produced by the thyroid gland primarily responsible for regulation of metabolism. This pathway is regulated via a closed-loop feedback process: Elevated concentrations of T3, and T4 in the blood plasma inhibit the production of TSH in the pituitary gland. As concentrations of these hormones decrease, the pituitary gland increases production of TSH, and by these processes, a feedback control system is set up to regulate the amount of thyroid hormones that are in the bloodstream. T3 is bound to thyroxine binding globulin (TBG), pre-albumin, and albumin. The actual distribution of T3 among these binding proteins is controversial as estimates range from 38-80% for TBG, 9-27% for pre-albumin, and 11-35% for albumin. The binding of these proteins is such that only % of the total T3 is present in solution as unbound or free T3. This free fraction represents the physiologically active thyroid hormone. When the level of TBG increases, the level of total T3 will increase to maintain the same level of unbound or free T3 in the bloodstream of an euthyroid individual. T3 is generally elevated in hyperthyroidism and decreased in hypothyroidism. The levels of T3 decreases in hypothyroidism, myxedema and chronic thyroiditis (Hashimoto s disease). Increased levels of T3 have been found in hyperthyroidism due to Grave s disease and Plummer s disease. The concentration of T3 is much less than that of T4, but its metabolic potency is much greater. The SelexOn T3 test strip quantitatively measures total T3 concentration in human blood miu/l ~ miu/l 0.5 ~ 5 miu/l 0.50 ng/ml ~ 5.00 ng/ml 0.8 ~ 1.7 ng/ml (Hyper) Abnormal (Hypo) Mean 4.34 miu/l 0.40 miu/l 30.4 miu/l SD (Standard Deviation) 0.38 miu/l 0.04 miu/l 2.69 miu/l CV (Coefficient Variation) 8.9% 10.2% 8.8% Mean 1.3 ng/ml 3.2 ng/ml SD (Standard Deviation) 0.12 ng/ml 0.28 ng/ml CV (Coefficient Variation) 9.2% 8.8% 1 Insert strip and inject whole blood 1 Insert strip and inject whole blood 18 Cat. No. Item Pack size INFIT01A SelexOn TSH Whole blood (venous) 20 test/box Cat. No. Item Pack size INFIX01A SelexOn T3 Whole blood (venous) 20 test/box 19

11 Thyroid diseases SelexOn T4 disease SelexOn Ag P.f The thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are tyrosine-based hormones produced by the thyroid gland primarily responsible for regulation of metabolism. This pathway is regulated via a closed-loop feedback process: Elevated concentrations of T3, and T4 in the blood plasma inhibit the production of TSH in the pituitary gland. As concentrations of these hormones decrease, the pituitary gland increases production of TSH, and by these processes, a feedback control system is set up to regulate the amount of thyroid hormones that are in the bloodstream. T4 is 99.9% bound to serum thyroxine binding proteins (TBP). The hormone is transported bound primarily to thyroxine binding globulin (TBG) and secondarily by thyroxine binding pre-albumin (TBPA) and albumin. Less than 0.05% of the total circulating T4 is unbound and therefore biologically active. When the level of TBG increases, the level of total T4 will increase to maintain the same level of unbound or free T4 in the bloodstream of an euthyroid individual. T4 is generally elevated in hyperthyroidism and decreased in hypothyroidism. The levels of T4 decreases in hypothyroidism, myxedema and chronic thyroiditis (Hashimoto s disease). Increased levels of T4 have been found in hyperthyroidism due to Grave s disease and Plummer s disease. The major form of thyroid hormone in the blood is T4, which has a longer half life than T3. The SelexOn T4 test strip quantitatively measures total T4 concentration in human blood. is a serious, sometimes fatal, parasitic disease characterized by fever, chills, and anemia and is caused by a parasite that is transmitted from one human to another by the bite of infected Anopheles mosquitoes. There are four kinds of malaria that can infect humans: Plasmodium falciparum, P.vivax, P.ovale, and P.malariae. The SelexOn Ag P.f test strip is a rapid, qualitative test for the detection of histidine-rich protein II (HRP-II) antigen of Plasmodium falciparum in human blood ug/dl ~ ug/dl 4.5 ~ 12.0 ug/dl EDTA-treated whole blood / capillary blood 5 ul Dilution buffer, Disposable sample applicator Mean 8.4 ug/dl 16.8 ug/dl SD (Standard Deviation) 0.78 ug/dl 1.18 ug/dl CV (Coefficient Variation) 9.3% 7.0% 96.0 % 99.0 % 1 Insert strip and inject whole blood 2 Touch <OK> button. 3 After 10 min, 1 Inject 5ul sample with disposable sample applicator into the blood injection hole. Ag P.f C P.f 2 Add 4 drops of dilution buffer into the buffer injection hole. Ag P.f C P.f 3 After 20 min, Ag P.f Ag P.f Ag P.f C P.f C P.f C P.f blood injection hole buffer injection hole Ag P.f C P.f 20 Cat. No. Item Pack size INFIY01A SelexOn T4 Whole blood (venous) 20 test/box Cat. No. Item Pack size INFIF01A SelexOn Ag P.f EDTA-treated whole blood / capillary blood 20 test/box 21

12 disease SelexOn Ag P.v disease SelexOn Ag P.f/P.v is a serious, sometimes fatal, parasitic disease characterized by fever, chills, and anemia and is caused by a parasite that is transmitted from one human to another by the bite of infected Anopheles mosquitoes. There are four kinds of malaria that can infect humans: Plasmodium falciparum, P.vivax, P.ovale, and P.malariae. The SelexOn Ag P.v test strip is a rapid, qualitative test for the detection of lactate dehydrogenase(ldh) antigen of Plasmodium vivax in human blood. is a serious, sometimes fatal, parasitic disease characterized by fever, chills, and anemia and is caused by a parasite that is transmitted from one human to another by the bite of infected Anopheles mosquitoes. There are four kinds of malaria that can infect humans: Plasmodium falciparum, P.vivax, P.ovale, and P.malariae. The SelexOn Ag P.f/P.v test strip is a rapid, qualitative test for the detection of HRP- II (Histidine-rich protein II) specific to Plasmodium falciparum and LDH (Lactate dehydrogenase) specific to Plasmodium vivax in human blood. EDTA-treated whole blood / Dilution buffer, EDTA-treated whole blood / Dilution buffer, capillary blood 5 ul Disposable sample applicator capillary blood Disposable sample applicator 5 ul P.f 98.0 % P.v 97.0 % 98.0 % 96.0 % 99.0 % 1 Inject 5ul sample with disposable sample applicator into the blood injection hole. 2 Add 4 drops of dilution buffer into the buffer injection hole. 3 After 20 min, P.f Ag P.f/P.v C P.v P.f 1 Inject 5ul sample with disposable sample applicator into the blood injection hole. Ag P.v C P.v 2 Add 4 drops of dilution buffer into the buffer injection hole. Ag P.v C P.v 3 After 20 min, Ag P.v Ag P.v Ag P.v C P.v C P.v C P.v Ag P.f/P.v C P.v P.f C P.v P.f Ag P.f/P.v blood injection hole buffer injection hole P.v Mixed Infection Ag P.f/P.v Ag P.f/P.v Ag P.f/P.v Ag P.f/P.v C P.v P.f C P.v P.f C P.v P.f C P.v P.f blood injection hole buffer injection hole Ag P.v C P.v Ag P.f/P.v C P.v P.f 22 Cat. No. Item Pack size INFIG01A SelexOn Ag P.v EDTA-treated whole blood / capillary blood 20 test/box Cat. No. Item Pack size INFII01A SelexOn Ag P.f/P.v EDTA-treated whole blood / capillary blood 20 test/box 23

13 disease SelexOn Hepatitis B infection SelexOn HBsAg P.f 97.0% Pan 96.0% 1 Inject 5ul sample with disposable sample applicator into the blood injection hole. blood injection hole is a mosquito-borne, hemolytic, febrile illness that infects over 200 million people and kills more than 1 million people per year. It is caused by four species of Plasmodium: P. falciparum, P. vivax, P. ovale, and P. malariae. These plasmodia all infect and destroy human erythrocytes, producing chills, fever, anemia, and splenomegaly. P. falciparum causes more sever disease than the other plasmodial species and accounts for most malaria deaths. P. falciparum and P. vivax are the most common pathogens, however, there is considerable geographic variation in species distribution. The SelexOn TM test strip is a rapid qualitative and differential test for the detection of HRP II (Histidine-rich protein II) specific to P. falciparum and pldh (Plasmodium lactate dehydrogenase) Pan specific to P. species in human blood. EDTA-treated whole blood /Capillary blood 5 ul 98.0 % 2 Add 4 drops of dilution buffer into the buffer injection hole. buffer injection hole Dilution buffer, Disposable sample applicator 3 After 20 min, P.f Pan Mixed Infection Hepatitis B is a widespread and serious liver disease. Hundreds of millions of people, most of them in regions with poor medical care, are chronically infected with the virus and face an elevated risk of acquiring liver cancer. The Hepatitis B virus (HBV) is made up of an inner core surrounded by an outer capsule. The outer capsule contains the HBsAg (Hepatitis B surface antigen). HBsAg will be detected 2 to 4 weeks before the transaminase level becomes abnormal and 3 to 5 weeks before the patient develops symptoms or becomes jaundiced. SelexOn HBsAg Test is a rapid chromatographic immunoassay for qualitative detection of Hepatitis B surface antigen in human blood. /Serum/Plasma sample from dilution mixture 99.0 % 99.0 % For using SelexOn meter (Quick Test Mode) 1 Apply the 100ul specimen sample to the dilution tube and then mix well. For using visual reading 1 Apply the 100ul specimen sample to the dilution tube and then mix well. 2 Inject 100ul sample from the dilution tube into the blood inlet. HBsAg 1C01 2 Inject 100ul sample from the dilution tube HBsAg 1C01 Detection Limit 3 After 20 min, insert the strip. Dilution tube 2 ng/ml 4 3 After 20 min, HBsAg 1C01 HBsAg 1C01 HBsAg 1C01 HBsAg 1C01 24 Cat. No. Item Pack size INFIPP01A SelexOn EDTA-treated whole blood / Capillary blood 20 test/box Cat. No. Item Pack size INFIB01A SelexOn HBsAg /Serum/Plasma 20 test/box 25

14 Hepatitis B infection SelexOn Anti-HBs Hepatitis C infection SelexOn HCV Hepatitis B is a widespread and serious liver disease. Hundreds of millions of people, most of them in regions with poor medical care, are chronically infected with the virus and face an elevated risk of acquiring liver cancer. The Hepatitis B virus (HBV) is made up of an inner core surrounded by an outer capsule. The outer capsule contains the HBsAg (Hepatitis B surface antigen). The detection of anti-hbs has become important in the follow up of patients with the Hepatitis B virus (HBV). It is also important when monitoring the recipients of vaccination with recombinant and natural anti-hbs. SelexOn Anti-HBs Test is a rapid chromatographic immunoassay for qualitative detection of Anti- HBs in human blood. Hepatitis C is an infectious disease affecting primarily the liver, caused by the hepatitis C virus (HCV). It is estimated that approximately 180 million people have been infected with the HCV and approximately 130 million people are chronic HCV carriers. HCV can be transmitted through intravenous drug abuse, sexual, and household contact. The infection is often asymptomatic, but ultimately, chronic infection are at risk for progressive liver disease leading to cirrhosis and/or liver cancer. When a person is infected with HCV, the immune system produces antibodies against the virus. The SelexOn HCV test strip qualitative measures HCV antibodies in human blood. EDTA-treated venous whole blood/ Dilution tube Serum/Plasma 50 ul sample from dilution mixture Serum/Plasma Detection Limit 30mIU/mL 97.5 % 99.5 % 94.5 % 99.0 % For using SelexOn meter (Quick Test Mode) 1 Apply the 50ul specimen sample to the dilution tube and then mix well. 2 Inject 100ul sample from the dilution tube into the blood inlet. 3 After 20 min, insert the strip. 4 1 Inject 100ul specimen sample(plasma or serum) into the sample inlet. 2 After 20 min, HCV 2001 Anti-HBs C T Anti-HBs Anti-HBs Anti-HBs Anti-HBs C C C C T T T T For using visual reading 1 Apply the 50ul specimen sample to the dilution tube and then mix well. 2 Inject 100ul sample from the dilution tube HCV After 20 min, HCV 2001 HCV 2001 HCV 2001 HCV Cat. No. Item Pack size INFIN01A SelexOn Anti-HBs Serum/Plasma 20 test/box Cat. No. Item Pack size INFIV01A SelexOn HCV EDTA-treated venous whole blood/serum/plasma 20 test/box 27

15 Dengue fever SelexOn Dengue NS1 Ag AIDS SelexOn HIV 1/2 The mosquito-borne dengue viruses cause dengue fever, a severe flu-like illness. Primary infection with dengue virus results in a self-limiting disease characterized by mild to high fever lasting 3 to 7 days, severe headache with pain behind the eyes, muscle and joint pain, rash and vomiting. Secondary infection is the more common form of the disease in many parts of Southeast Asia and South America. This form of the disease is more serious and can result in DHF and DSS. The SelexOn Dengue NS1 Ag test strip qualitatively measures dengue virus NS1 antigen in human blood. Human immunodeficiency virus (HIV) is a lentivirus that causes acquired immunodeficiency syndrome (AIDS), a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. Infection with HIV occurs by the transfer of blood, semen, vaginal fluid, pre-ejaculate, or breast milk. Within these bodily fluids, HIV is present as both free virus particles and virus within infected immune cells. HIV-1 is more virulent, more infective, and is the cause of the majority of HIV infections globally. The lower infectivity of HIV-2 compared to HIV-1 implies that fewer of those exposed to HIV-2 will be infected per exposure. The SelexOn HIV 1/2 test strip qualitatively measures HIV-1 and HIV-2 concentration in human blood. Whole blood/serum/plasma Dilution buffer, 20 ul Disposable sample applicator EDTA-treated venous whole blood/ Serum/Plasma 99.7 % 99.6 % 91.5 % 97.5 % 1 Inject 20ul specimen into the sample inlet. 2 Add 4 drops of dilution buffer into the diluent buffer inlet. 3 After 20 min, HIV-1 HIV 1/2 C Inject 100ul specimen sample into the blood inlet. NS1 Ag C T 2 After 20 min, NS1 Ag NS1 Ag NS1 Ag HIV 1/2 C 2 1 C 2 1 HIV 1/2 HIV-2 HIV Mixed Infection HIV 1/2 HIV 1/2 HIV 1/2 HIV 1/2 C 2 1 C 2 1 C 2 1 C 2 1 NS1 Ag C T HIV 1/2 C Cat. No. Item Pack size INFIW01A SelexOn Dengue NS1 Ag EDTA-treated venous whole blood/serum/plasma 20 test/box Cat. No. Item Pack size INFIZ01A SelexOn HIV 1/2 Whole blood/serum/plasma 20 test/box 29

16 Inflammation SelexOn CRP Diabetes mellitus SelexOn C-peptide The C-Reactive Protein (CRP) is synthesized by the liver in response to interleukin-6 and well known as one of the classical acute-phase reactants and as a marker of inflammation. CRP is the first acute-phase protein to be described and is an exquisitely sensitive systemic marker of inflammation and tissue damage. In response to infection, the serum CRP concentration can increase by up to 1000 fold. Elevated CRP levels have been reported in patients with infection, chronic inflammatory disorders, myocardial infarction, pulmonary disorders, atherosclerosis, cancer, metabolic syndrome, and depression. The SelexOn TM CRP test strip quantitatively measures CRP concentration in human blood. C-Peptide is devoid of any biological activity but appears to be necessary to maintain the structural integrity of insulin. Although insulin and C-Peptide are secreted into portal circulation in equimolar concentrations, fasting levels of C-Peptide are 5-10 fold higher than those of insulin owing to the longer half-life of C-Peptide. The liver does not extract C-Peptide however; it is removed from the circulation by degradation in the kidneys with a fraction passing out unchanged in urine. Hence urine C-Peptide levels correlate well with fasting C-Peptide levels in serum. The glucagon stimulated C-Peptide determination is often used for differential diagnosis of insulin-dependent from noninsulin-dependent diabetic patients. The SelexOn TM C-peptide test strip quantitatively measures C-peptide concentration in human blood. 5.00~ mg/l 10 mg/l 5 ul sample from dilution mixture Dilution tube Mean 3.18 mg/l mg/l SD (Standard Deviation) 0.29 mg/l 5.13 mg/l CV (Coefficient Variation) 9.4% 5.9% 0.20~15.00 ng/ml 0.5~2.2 ng/ml /Capillary blood Mean 6.08 ng/ml 0.41 ng/ml SD (Standard Deviation) 0.45 ng/ml 0.03 ng/ml CV (Coefficient Variation) 7.4% 7.0% 1 Apply the 5ul whole blood to the dilution tube and then mix well. 2 Insert strip and inject 100ul sample from the dilution tube 3 Touch <OK> button. 4 After 10 min, 1 Insert strip and inject specimen (venous whole blood/capillary blood) CRP 2E mg/l CRP 2E01 C-peptide ng/ml C-peptide Cat. No. Item Pack size INFIK01A SelexOn CRP Whole blood (venous) 20 test/box Cat. No. Item Pack size INFICP01A SelexOn C-peptide Whole blood (venous) / Capillary blood 20 test/box 31

17 Diabetes mellitus SelexOn Insulin Secretion of insulin is mainly controlled by plasma glucose concentration, and the hormone has a number of important metabolic actions. Its principal function is to control the uptake and utilisation of glucose in peripheral tissues via the glucose transporter. This and other hypoglycaemic activities, such as the inhibition of hepatic gluconeogenesis and glycogenolysis are counteracted by the hyperglycaemic hormones including glucagon, epinephrine (adrenaline), growth hormone and cortisol. Insulin concentrations are severely reduced in insulin-dependent diabetes mellitus (IDDM) and some other conditions such as hypopituitarism. Insulin levels are raised in non-insulin-dependent diabetes mellitus (NIDDM), obesity, insulinoma and some endocrine dysfunctions such as Cushing s syndrome and acromegaly. The SelexOn TM Insulin test strip quantitatively measures insulin concentration in human blood. SelexOn Vitamin D Vitamin D is a steroid hormone involved in the active intestinal absorption of calcium and in the regulation of its homeostasis. It plays a vital role in the formation and maintenance of strong, healthy bones. Vitamin D deficiency has long been associated with rickets in children and osteomalacia in adults; and long-term insufficiency of calcium and vitamin D leads to osteoporosis. Additionally, in recent years, vitamin D has become an assay of general health status, and there have been multiple publications linking vitamin D deficiency to several disease states, such as cancer, cardiovascular disease, diabetes, and autoimmune diseases. The SelexOn TM Vitamin D test strip quantitatively measures Vitamin D (total 25-OH Vitamin D) concentration in human blood ~ miu/l 10.00~70.00 ng/ml 30 miu/l 30 ng/ml /Capillary blood Mean miu/l miu/l SD (Standard Deviation) 1.48 miu/l miu/l CV (Coefficient Variation) 7.3% 8.2% (Deficient) Abnormal(Insufficient) Mean ng/ml ng/ml ng/ml SD (Standard Deviation) 4.61 ng/ml 1.09 ng/ml 1.66 ng/ml CV (Coefficient Variation) 5.6% 7.9% 6.2% 1 Insert strip and inject specimen (venous whole blood/capillary blood) 1 Insert strip and inject whole blood Insulin miu/l Insulin 3801 Vitamin D 2C ng/ml Vitamin D 2C01 32 Cat. No. Item Pack size INFIIS01A SelexOn Insulin Whole blood (venous) / Capillary blood 20 test/box Cat. No. Item Pack size INFIVD01A SelexOn Vitamin D Whole blood (venous) 20 test/box 33