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

Infinite Liquid a-Amylase 12 ml Diagnostic Reagent from Accurex (Pack Size : 6 x 2 ml). a-Amylase reagent is used for determination of amylase activity based on kinetic method using Gal G2 – a CNP. Amylase is a ready-to-use reagent. Normal amylase level is 40 to 140 units per liter (U/L) or 0.38 to 1.42 microkat/L (µkat/L). Infinite a-Amylase can be used on any Spectrophotometer, Discrete semiautomated & Automated analyzers. Reaction type is Kinetic. Accurex Biomedical is the first biochemical reagents manufacturing company in India About Infinite a-Amylase ‘is a reagent set for determination of amylase activity based on kinetic method using Gal G2 – a CNP. Infinite a-Amylase is a ready-to-use reagent. Infinite a-Amylase can be determined in just 21/2 minutes at 37°C. Infinite a-Amylase is linear upto 2000 IU/1. Infinite a-Amylase is a High Stability Reagent. Infinite a-Amylase can be used on any Spectrophotometer, Discrete semiautomated and Automated analyzers. Programme can be designed for any specific analyzer upon request. Pack Size : 6 x 2 ml Principle Amylase test involves use of a chromogenic substrate Gal G, – a CNP (2-chloro-4-nitrophenyl linked with galactosyl maltoside). The direct action of amylase with this substrate results in the release of more than 90% of 2-chloro-4-nitrophenol, which can be monitored by kinetic assay at 405 nm. The increase in absorbance is directly proportional to the amylase activity in the sample. Quality Control To ensure adequate quality control, it is recommended that each batch should include a normal and abnormal commercial reference control serum. It should be realized that the use of quality control material checks both instrument and reagent functions together. Factors which might affect the performance of this test include proper instrument function, temperature control, cleanliness of glassware and accuracy of pipetting. Other Details Mix thoroughly and transfer the assay mixture immediately to the thermostated cuvette and start the stopwatch simultaneously. Record the first reading at 60 second and subsequently three more readings with 30 seconds interval at 405 nm.

INTENDED USE The Finecare™ Estradiol (E2) Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters is for quantitative measurement of Estradiol (E2) in human whole blood, serum or plasma. The test is used as an aid to the evaluation of ovarian diseases. STORAGE AND STABILITY 1. Store the test kit at 4～30℃ up to the expiration date. 2. If removed from refrigerator, allow the test for 30 minutes to return to room temperature 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.

INTENDED USE The Finecare™ β2-MG Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of β2-MG (Beta-2-Microglobulin) concentration in human plasma, serum or whole blood. The test is used as an aid for the diagnosis of renal disease. 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™ Lp-PLA2 Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Lp-PLA2 in human serum, plasma or whole blood. The test is used as an aid to the assessment of the coronary heart disease (CHD) and ischemic stroke. 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.

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

The OnSite HIV 1/2 Ab Plus Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of HIV-1 and HIV-2 antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood. 3rd Generation, double-antigen based test to increase the sensitivity in early detection Requires only 20 µL of specimen Use serum, plasma or whole blood Results available within 15 minutes to allow prompt action to be taken at the point of care Performance validated with BBI low titre panel and Chinese FDA HIV Ab panel Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (20 uL) Sample diluent (REF SB-R0011, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance Flyer Inserts TB-HIV Rapid Test Presentation U.S. CDC HIV Homepage: About HIV WHO: Health Topic for HIV U.S. CDC HIV Testing 101

The OnSite Duo HSV-1/2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. This test can be performed in 10 minutes by minimally skilled personnel without the use of laboratory equipment. This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with HSV-1 and/or HSV-2. The OnSite Duo HSV-1/2 IgG/IgM Rapid Test uses HSV-1 glycoprotein G1 and HSV-2 glycoprotein G2 for the specific detection and differentiation of IgG and IgM antibodies to HSV-1 and HSV-2 in serum, plasma and whole blood. An HSV-1 and/or HSV-2 IgM positive result indicates an active infection, which may be primary or recurrent. An HSV-1 and/or HSV-2 IgG positive result indicates a recent or past infection. However, a negative test result does not preclude the possibility of infection with HSV-1 and/or HSV-2. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device. Clinical accuracy: 90.6% sensitivity and 91.4% specificity for anti-HSV-1 IgG detection 93.8% sensitivity and 96.0% specificity for anti-HSV-2 IgG detection 85.0% overall agreement for anti-HSV-1 IgM detection comparing to commercial ELISA 100% overall agreement for anti-HSV-2 IgM detection comparing to BBI Panel (PTH202) Positive rate on random clinical specimens:8% for IgG anti-HSV-1 and 4.9% for IgM anti-HSV-1 (n=10,000); 4.6% for anti-HSV-2 IgG and 1.7% for anti-HSV-2 IgM Cross reactivity: no cross reactivity with the following disease states or special conditions, respectively: palladium, H. pylori, Dengue, Malaria, Typhoid, Toxoplasma, Rubella, CMV, hCG, TB, HAV, HBV, HCV, HEV, HIV, ANA, HAMA, RF (up to 1,000 IU/mL) Interference: No interference was seen with Albumin 60 g/L , Hemoglobin 2 g/L, Bilirubin 20 mg/dL, Heparin 3,000 U/L, Creatinine 442 µmol/L, Salicylic acid 4.24 mmol/L, EDTA 3.4 µmol/L, Sodium citrate 8%, Glucose 55 mmol/L Shelf life: 24 months 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) 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)

CLIAlyzer is an intuitive bench-top chemiluminescent analyzer allowing for quick operation and use. CLIAlyzer delivers results when paired with our RapidLight tests. Laboratories can run multiple specimen options and six tests simultaneously, providing up to 24 test results per hour. The CLIAlyzer is an in vitro diagnostic device used for the quantitative determination of concentrations of various analytes found in serum, whole blood, or plasma specimens. Compact size Automated walkaway system Easy operation with 7-inch touchscreen Barcode reader reduces manual entry errors Results on screen, on a printout, or uploaded to database Storage capacity of 100,000 test results Laboratory Information System (LIS) connectivity High accuracy and precision with highly sensitive PMT for signal detection Assay results as quick as 15 minutes (test-specific) Compatibility with whole blood, serum, plasma (test-specific) Six cartridge positions Automatic detection of test parameter through barcode on test strip, thus reducing any user-related errors Low maintenance analyzer due to no storage of buffer System: Automated chemiluminescence system Interface: 7-inch color touch screen Methodology: Magnetic particle-based assay with chemiluminescence detection Reaction mode: Batch mode Sample type: Serum, plasma, whole blood (test specific) Sample positions: 6 Volume: 420mm x 610mm x 321mm Weight: 35kg Connectivity: USB, RS232, LIS connection Barcode Scanner: 1-D & 2-D barcode