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Rapid Test

Intended Use Hepacard is visual, rapid, sensitive and accurate one step immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) in Human serum or plasma.The assay is intended to be used as an aid in the recognition and diagnosis of acute infections and chronic infectious carriers of the Hepatitis B Virus(HBV). Salient Features Detects all the 11 subtype of HBsAg. Antigen Sensitivity- 0.5 ng/ml. No sample preparation required. See through Device for easy result interpretation. Shelf life-30 months at 2-30°C. WHO Evaluated with 100% Sensitivity.

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Rapid Test

The OnSite HBV-5 Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B e-antigen (HBeAg), hepatitis B e-antibody (HBeAb), and hepatitis B core antibody (HBcAb) in human serum or plasma. It is intended to be used by healthcare professionals to aid in the diagnosis of infection with hepatitis B virus (HBV). Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of healthcare providers. Alternative test method(s) should be considered to confirm the test results obtained by this device. Panel format cassette to conveniently test for five targets at once Utilize all markers to help distinguish between acute and chronic infections Result in 15 minutes Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Package insert (instruction for use) CTK Products at a Glance Inserts Poster U.S. CDC: hepatitis B Virus FAQs for Health Professionals WHO: Health Topic for Hepatitis

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Rapid Test

Buy AccuTest HBsAg Rapid Card Test (50 Tests) Online from Accurex. HBsAg means Hepatitis B surface antigen which is a protein on the surface of hepatitis B virus. It can be detected in high levels in serum during acute or chronic hepatitis B virus infection. HBsAg positive indicates that the person is infectious. The hbsag test kit is a one-step immunochromatographic assay based on the antigen capture, or Sandwich principle. HBsAg positive treatment may include Antiviral medications. AccuTest HBsAg Card Test Hepatitis BHepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. An estimated 240 million people are chronically infected with hepatitis B (defined as hepatitis B surface antigen positive for at least 6 months). Laboratory diagnosis of hepatitis B infection focuses on the detection of the hepatitis B surface antigen HBsAg. Hepatitis B surface antigen (HBsAg) consists of lipid carbohydrate and protein elements; the protein moiety provides a marker for identification of chronic, infectious BBV infections. Hepatitis B is transmitted sexually or intravenously and has an incubation period of six months. If not diagnosed properly and in time, it can develop into acute or chronic infection, liver cirrhosis and fulminant hepatitis. This test is very useful for screening blood donors, to find out whether they are HBsAg positive before collection of blood. Principle: AccuTest HBsAg is a qualitative test based on immunochromatography sandwich principle. The test card includes a combination of monoclonal anti-body gold conjugate (colloidal gold) and polyclonal solid phase antibodies which selectively binds Hepatitis B surface antigen with high degree of sensitivity. The HBsAg test is a one-step immunochromatographic assay based on the antigen capture, or Sandwich principle. The method uses monoclonal antibodies conjugated to colloidal gold and polyclonal antibodies immobilized on a nitrocellulose strip in a thin line. The test sample is introduced into well and flows laterally through an absorbent pad where it mixes with the signal reagent. If sample contains HBsAg, the colloidal gold-antibody (mouse) conjugate binds to the antigen, forming an antigen-antibody-colloidal gold complex. The complexes then migrate through the nitrocellulose strip by capillary action, which are stopped by an immobilized antibody zone forming a purple band. The formation of the first purple band (T zone) is indicative of hepatitis positive. To serve as a procedural control, an additional line of antibody antimouse IgG has been immobilized on the card. If the test is performed correctly, this will result in the formation of purple and upon contact with the conjugate as a control line. Safety Information AccuTest HBsAg test kit is designed lor detection of Hepalitis B Surface Antigenin the specimen. As with all diagnostic tests, il is recommended to interpret all the results in line wilh clinical manifestations, other lest resulls & clinicians’s view colleclively. If the lest device is showing stagnancy in flow on chromalography, it is most likely due lo problem in the sample. In this case, relest with a fresh sample or diluted sample. Direction for Use Test Procedure: 1. Allow the test, specimen and or control to room temperature prior to the testing 2. Remove one test card from the pouch and place it on a clean flat surface 3. Using the dropper provided one drop of serum/plasma or W. blood sample (25 ul), wait for few seconds till the Whole blood absorbed by sample pad (approx. 30 second), 4. Add 2-3 drops of buffer (60 ul) into the sample well. (If needed add one more drop of assay buffer). 5. Let reaction proceed until the appearance of positive line and control line or up to 20 minutes. 6. Read results after 20 minutes, strong positive reaction may visible within 5 minutes. 7. If negative or questionable results are obtained, the HBV infection is suspected, the test should be repeated ona fresh serum specimen. Storage: AccuTest HBsAg should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch.

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immunoassayReagents

INTENDED USE The Finecare™ CRP/PCT Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of C-Reactive Protein (CRP) and Procalcitonin (PCT) in human whole blood, serum or plasma. This test is used as an aid to see infection and inflammation and used to aid in the early detection of clinically relevant bacterial infections. 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.

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immunoassayReagents

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.

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immunoassayReagents

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.

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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 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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