AFIAS 6 (Automatic Fluorescence Immuno-Assay)

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Leonard Ramsey
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AFIAS 6 (Automatic Fluorescence Immuno-Assay) Each SMART kit contains ten (10)

Fluorescence Immuno-Assay) is a next-generation, full-automatic, desktop

target analytes in human blood, urine and other specimens in various specially

1 AFIAS 6 (Automatic Fluorescence Immuno-Assay) Each SMART kit contains ten (10) cartridges, one (1) ID Chip, and one (1) instruction for use AFIAS 6 (Automatic Fluorescence Immuno-Assay) is a next-generation, full-automatic, desktop fluorescence processing and scanning instrument for measuring the concentration of target analytes in human blood, urine and other specimens in various specially designed cartridges, which will be properly processed and tested in accordance with ichroma SMART Immunoassay.

2 Company At a Glance Boditech Med, Inc. was founded by Dr. Eui Yul Choi, an entrepreneur scientist whose mission is to make diagnostics affordable and accessible to everyone and help them to lead a happy and healthy life. Since the inception of the company in 1998, it has expanded its business in over 80 different countries with two main products; ichroma and Hemochroma plus. With our innovative technology, we have achieved No. 1 position in China on a single reagent basis since We have also formed a partnership with a top healthcare company in India and will continue its fast growth over the next decades. Boditech Med, Inc. aims to become a world s top 10 in vitro diagnostic company in To do so, we will make incessant efforts to offer innovative and affordable products including the ichroma SMART, a semi-automatic analyzer in 2013 and more disease markers to the global market. HQs, Boditech Med, Inc. South Korea Technology ichroma is a portable diagnostic system using a fluorescence immunoassay that quantifies analytes by measuring laser-induced epifluorescence of test strips. ichroma technology utilizes a lateral flow-type assay method in which the labeled antibody bound in analytes is captured while migrating through the nitrocellulose membrane. The system consists of a fluorescence reader and test cartridges. It can be used to screen a variety of diseases, such as cardiovascula diseases, cancers, diabetes, infectious diseases and hormonal disorder. Our continuous efforts with product innovation enabled us to introduce the world s first TSH and hcg diagnostic tests using whole blood in All of ichroma tests are CE-certified, while ichroma reader and CRP are FDA approved.

Multi Single Specification Specification Dimensions 697 mm (W) x 553 mm (L) x 528 mm (H) Dimensions 210 mm (W) x 308 mm (L) x 398 mm (H) Weight 42 kg Weight 6.

RS232, LAN, USB, touch screen, Built-in printer Interface RS232, LAN, USB, touch screen, Built-in printer (optional; Barcode scanner, keyboard) (optional; Barcode scanner, keyboard) Test available

3 Multi Single Specification Specification Dimensions 697 mm (W) x 553 mm (L) x 528 mm (H) Dimensions 210 mm (W) x 308 mm (L) x 398 mm (H) Weight 42 kg Weight 6.78 kg Data storage 1,000 Test Data storage 1,000 Test Data output LCD/Thermal Printer Data output LCD/Thermal Printer Display LCD (800 x 480 graphic LCD) Display LCD (800 x 480 graphic LCD) Interface RS232, LAN, USB, touch screen, Built-in printer Interface RS232, LAN, USB, touch screen, Built-in printer (optional; Barcode scanner, keyboard) (optional; Barcode scanner, keyboard) Test available Product class Test item Diseases Sample type Reaction time Measurement ranges Cardiac D-Dimer hscrp Blood clotting Cardiovascular Inflammation Plasma, 50-10,000 ng/ml mg/l Tumor PSA Prostate Cancer, ng/ml Hormone FSH Infertility / Menopause, mlu/ml LH Infertility / Ovulation, mlu/ml PRL Sexual Disorder, ng/ml Total βhcg Fertility, 5-50,000 mlu/ml TSH Thyroid Function μiu/ml Infection CRP Inflammation Sepsis,, mg/l ng/ml Comming Soon All tests give quantitative results and are CE-marked. Tn-I, CK-MB, Myoglobin, AFP, CEA, ifob, HbA1c, Microalbumin, T4, hcg, Testosterone, Cortisol, RF IgM, Ferritin

New HbA1c Test Enhanced Reliability & Reproducibility with is a thermostatic attachment to -CHRO MATM designed

Description: New HbA1c test Immunological assay Sample volume: 5 µl Pre-incubation time: 5-30 min.

certified Tosoh G7 HPLC HbA1c(%) 16.0 14.0 12.0 10.0 8.0 6.0 4.0 2.0 y = 0.9939x + 0.0038 R 2 = 0.

4 New HbA1c Test Enhanced Reliability & Reproducibility with is a thermostatic attachment to -CHRO MATM designed for HbA1c test. pre-conditions HbA1c test strips for accurate and reproducible results. Description: New HbA1c test Immunological assay Sample volume: 5 µl Pre-incubation time: 5-30 min. Reaction time: 12 minutes Measurement range: 4-15% Display: % of HbA1c & Hemoglobin concentration NGSP certified Tosoh G7 HPLC HbA1c(%) y = x R 2 = N = 150 HbA1c vs Tosoh G HbA1c(%) Go to for more information. Contact us: sales@boditech.co.kr

Quantitative Assay: Fast & Accurate Description Principle: Fluorescence immunoassay Detection range: 0.1-100 ng/ml Cut-off: 0.

5 Quantitative Assay: Fast & Accurate Description Principle: Fluorescence immunoassay Detection range: ng/ml Cut-off: 0.5 ng/ml Samples: Whole Blood, Serum, plasma Test time: 12 minutes Analyzer: ichroma Reader, ichroma SMART ichroma is a fluorescence immunoassay for quantitative determination of procalcitonin () in human serum and plasma. is known as a useful marker in the diagnosis of bacterial infection and sepsis. Sepsis is a life-threatening condition that arises when the body's immune response to an infection damages its own tissues and organs. Sepsis is the leading cause of death from infection around the world, which lead millions of people around the world to death every year. is a better biomarker for sepsis than others. The value obtained by ichroma is comparable to that of high-end machine. Sensitivity Specificity 1.00 TM ichroma SMART [ng/ml] y = x R = N = 74 Comparability Roche Cobas e411 [ng/ml] levels accurately differentiate sepsis from noninfectious inflammation. has been demonstrated to be the best marker for differentiating patients with sepsis from those with systemic inflammatory reaction not related to infectious cause. Intra-assay Con. (ng/ml) Avg. SD CV% Inter-assay Avg. SD CV% Ref. Simon L. et al. Clin Infect Dis. 2004; 39: Boditech Med Inc. 43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do, , KOREA Tel Fax sales@boditech. co.kr Website : REV. 28_2015_04_13

6 Test Markers All tests are quantitative and CE-marked Product class Test item Diseases Sample type Reaction time Measurement ranges Tn-I Myocardial infarction ng/ml CK-MB Myocardial infarction ng/ml Cardiac D-Dimer Thrombosis Plasma 50-10,000 ng/ml Myoglobin hscrp Myocardial infarction Cardiovascular inflammation ng/ml mg/l Cancer PSA AFP CEA Prostate cancer Liver cancer Cancers ng/ml ng/ml ng/ml ng/ml ifob Coloerctal cancer Feces (stool) 25-1,000 ng/ml HbA1c Diabetes mellitus 4-15 % Diabetes Microalbumin Diabetes mellitus Urine mg/l Cystatin C Renal disease mg/l TSH μiu/ml TSH WB μiu/ml TSH Plus T3 16 min μiu/ml μiu/ml ng/ml ( nmol/l) T nmol/l Hormone FSH Progesterone Menopause/infertility Fertility mlu/ml ng/ml ( nmol/l) hcg Pregnancy 2-3,000 mlu/ml βhcg Fertility 5-50,000 mlu/ml LH Ovulation mlu/ml PRL Sexual disorder & infertility ng/ml Testosterone Sexual disorder 1-10 ng/ml Cortisol Metabolism nmol/l Infection CRP Inflammation Sepsis mg/l ng/ml Rheumatoid Arthritis RF IgM Rheumatoid Arthritis 5 min lu/ml Others Ferritin Anemia 10-1,000 ng/ml ASO Rheumatic fever lu/ml Markers coming soon: Vitamin D, NT-pro BNP, HbsAg, Total IgE and more Boditech Med Inc. 43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do, , KOREA Tel Fax sales@boditech. co.kr Website : Local Distributor

The next generation portable diagnostics system: Over 20 parameters available!

www.boditech.co.kr Immunofluorescence Assay System The next generation portable diagnostics system: Over 20 parameters available! Quantitative test results on the spot is an immunofluorescencebased diagnostics