The OnSite Malaria Pf/Pv Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of antibodies including IgG, IgM and IgA to Plasmodium falciparum (Pf) and Plasmodium vivax (Pv) in human serum, plasma or whole blood. Uses serum, plasma or whole blood specimens Utilizes highly purified antigen to ensure test sensitivity and specificity Detects total antibodies to Pf and Pv Ease of use, requires minimal training of personnel Quick turnaround time to results Individually sealed foil pouches containing: One cassette device One desiccant Two-mark capillary tubes (10/20 µL) Sample diluent (REF SB-R0111, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Flyer Inserts Malaria Pf/Pv Ag Rapid Test Presentation Malaria Pf/Pan Ag Rapid Test Presentation Poster U.S. CDC Malaria Homepage: About Malaria WHO: Malaria Fact Sheets

CRP (C-reactive protein) Rapid Quantitative Test The Finecare™ CRP Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of C-reactive protein (CRP) in human whole blood,serum or plasma. The test is used as an aid to predict future cardiovascular diseases (CVD) as well as to see infection and inflammation. STORAGE AND STABILITY 1. Store the detector buffer at 4～30°C. The buffer is stable up to 24 months. 2. Store Finecare™ CRP Rapid Quantitative Test Cartridge at 4～30°C, shelf life is up to 24 months. 3. Test Cartridge should be used within 1 hour after opening the pack.

INTENDED USE The Finecare™ Myo Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Myoglobin in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of acute myocardial infarction (AMI). STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

INTENDED USE The Finecare™ CK-MB Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Creatine Kinase-MB (CK-MB) in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of acute myocardial infarction (AMI). STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

H-FABP Rapid Quantitative Test Finecare™ H-FABP Rapid Quantitative Test is a fluorescence immunoassay for quantitative measurement of Heart-type Fatty Acid Binding Protein (H-FABP) in human whole blood, serum or plasma. It is used for diagnosis of myocardial infarction.With original qualify control. STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

INTENDED USE The Finecare™ One Step cTn I/CK-MB/Myo Rapid Quantitative Test a fluorescence immunoassay to be used along with Finecare™ FIA System for quantitative determination of cardiac Troponin I (cTn I), MB Isoenzyme of Creatine Kinase (CK-MB) and Myoglobin (Myo) in human whole blood, serum or plasma. The test is used as an aid to the diagnosis of myocardial infarction. STORAGE AND STABILITY 1. Store Finecare™ One Step cTn I/CK-MB/Myo Rapid Quantitative Test at 4 ℃~30 ℃. Do not freeze. Shelf life is up to 24 months, refer to label for expiration date 2. If removed from refrigeration, allow the Test Cartridge for 30 minutes to reach room temperature (25±2℃) before testing. 3. Once opened, commence to use the Test Cartridge within an hour. 4. Do not remove the device from the pouch until ready to use. Keep the Test Cartridges away from light.

INTENDED USE The Finecare™ cTn I/NT-proBNP Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of cardiac Troponin I (cTn I) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of myocardial infarction and suspected congestive heart failure. STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

INTENDED USE The Finecare™ One Step cTnT Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay for quantitative determination of cTnT concentration in human venous whole blood, serum or plasma specimen. It is mainly used as an aid to the diagnosis of myocardial infarction. STORAGE AND STABILITY 1.Store at 4~30 °C up to the expiration date printed on the package. 2. Do not remove the Test Cartridges from the pouch until ready to use. The Test Cartridges should be used within 1 hour once opened.

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