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'one cassette device'

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immunoassayReagents

INTENDED USE The Finecare™ Testosterone Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative measurement of Testosterone in human whole blood, serum or plasma. The test is to be used as an aid in the diagnosis of diseases related to abnormal testosterone levels. STORAGE AND STABILITY 1. Store the test kit at 4~30ºC up to the expiration date printed on the package. 2. If removed from refrigerator, allow the test to return to room temperature for 30 minutes before testing. 3. Do not remove the cassette from the pouch until ready to use. The test cassette should be used within 1 hour once opened.

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Rapid Test

The OnSite HSV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. Unique test that utilizes glycoprotein G2 to differentiate between HSV-1. and HSV-2 that allows for an early start of treatment action. Immediate determination of either acute or chronic infection by detecting and differentiating IgG and IgM anti-HSV-2. High confidence as test is in agreement with market leading European ELISA: 95.3% IgG; 100% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0213, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

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Rapid Test

The OnSite HSV-1 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) in human serum, plasma or whole blood. Type-specific detection by utilizing glycoprotein G1. Single test that detects and differentiates IgG and IgM anti-HSV-1. High confidence as test is in agreement with market leading ELISA test: 90.7% IgG; 85.0% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during the patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0203, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

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Rapid Test

The OnSite Troponin I Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma or whole blood at a level equal to or higher than 1 ng/mL. It can be performed within 15 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite Troponin I Combo Rapid Test is intended to be used by healthcare professionals as an aid in the diagnosis of acute myocardial infarction (AMI). Any use or interpretation of this preliminary test result must also rely on patient’s symptoms and the professional judgment of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device. Normally the level of cTnI in the blood is very low. cTnI is released into the blood stream in forms of free cTnI and cTnI-C-T complex at 4-6 hours after myocardial cell damage. The elevated level of cTnI could be as high as 50 ng/mL during 60-80 hours after AMI and remains detectable for up to 10-14 days post AMI. Therefore, circulating cTnI is a specific and sensitive marker for AMI. Clinical performance: Relative Sensitivity: 95.8% (95% CI: 91.5-97.9%) compared to a reference CLIA Relative Specificity: 99.7% (95% CI: 98.8-99.9%) Analytical sensitivity: The detection limit of cTnI is 1.0 ng/mL or greater in serum, plasma or whole blood specimen Cross-reactivity: No cross reactivity with 10 µg/mL skeletal muscle TnI, 2,000 ng/mL cardiac muscle TnT, 20 µg/mL cardiac muscle Myosin Dose hook effect: No hook effect was observed for cTnI at concentrations up to 3,521 µg/mL Interference: No interference was seen with 20 mg/dl Acetaminophen, 20 mg/dl Acetylsalicylic acid, 10.5 g/dl Albumin, 20 mg/dl Ascorbic acid, 1,000 mg/dl Bilirubin, 20 mg/dl Caffeine, 800 mg/dl Cholesterol, 200 mg/dl Creatinine, 20 mg/dl Gentistic acid, 1,000 mg/dl Hemoglobin, 600 mg/dl Oxilic acid, 1,600 mg/dl Triglycerides Shelf life: 24 months Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample diluent (REF SB-R3002, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Insert MedlinePlus: Troponin Test Poster

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Rapid Test

The OnSite H. pylori Ab Combo Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG, IgM and IgA) against Helicobacter pylori (H. pylori) in human serum, plasma or whole blood. Uses serum, plasma or whole blood specimen No need to avoid certain medications Non-invasive, easy to perform procedure Time to result is 15 minutes Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample diluent (REF SB-R0191, 5 mL) Package insert (instruction for use) CTK Products at a Glance Flyer H. pylori Rapid Tests Training Presentation Inserts Poster U.S. CDC-H. pylori: HP Facts

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Rapid Test

The OnSite Typhoid IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the detection and differentiation of IgG and IgM anti-Salmonella typhi (S. typhi) and paratyphi in human serum, plasma or whole blood. Utilizes O antigen and H antigen from both typhi and paratyphi serovars to maximize sensitivity Differentiates between IgG and IgM to determine stage of infection One step procedure minimizes operator error due to sample preparation Test result within 15 minutes allows medical professionals to take immediate action High level of reproducibility Test kits can be used and stored in a wide range of temperatures Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample Diluent (REF SB-R0161, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance Flyer Inserts U.S. CDC Typhoid Homepage: About Typhoid WHO: Health Topic for Typhoid

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Rapid Test

The OnSite TB IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM anti-Mycobacterium tuberculosis (anti-M. TB) and IgG anti-M. TB in human serum, plasma or whole blood. A lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM and IgG anti-Mycobacterium tuberculosis (anti-M. TB) in human serum, plasma or whole blood. Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample diluent (REF SB-R0053, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Flyer Inserts TB-HIV Rapid Test Presentation U.S. CDC Tuberculosis Homepage: About Tuberculosis WHO-Tuberculosis Fact sheets The World TB Day newsletter

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Rapid Test

The OnSite Chikungunya IgM Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM anti-chikungunya (CHIK) virus in human serum, plasma or whole blood. Uses serum, plasma or whole blood specimen Utilizes recombinant antigen derived from the CHIK structure protein IgM immunoassay is the most practical lab method Distinguish from dengue infection which presents with similar symptoms Clinical performance: Sensitivity: 90.4% Specificity: 98.0% comparing to a commercial ELISA Cross-Reactivity: no cross-reactivity found on 10-40 specimens from the 14 disease states and special conditions, such as dengue, Zika, malaria, HIV, TB, HAV, pregnant woman and others No interference with some common substances, such as Acetominophen (20 mg/dL), Heparin (3000 U/L), Ascorbic acid (20 mg/dL), Human IgG (1000 mg/dL), Bilirubin (20 mg/dL), Glucose (55 mmol/L), Creatinine (442 μmol/L), Salicylic acid (4.34 mmol/L), EDTA (3.4 μmol/L), Sodium citrate (3.8%) Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (5 μL) Sample diluent (REF SB-R0066, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Inserts U.S. CDC Chikungunya Virus Homepage: (Transmission, Prevention, etc.) WHO: Chikungunya Virus Fact Sheets

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