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'relative specificity'

Items tagged with 'relative specificity'

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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

Malaria Pan/ Pf Antigen Test is an in vitro diagnostic rapid test based on the principle of immunochromatography on a membrane for simultaneous and differential detection of Pan (LDH antigens of Plasmodium vivax, Plasmodium falciparum, Plasmodium ovale and Plasmodium malariae) and Plasmodium falciparum HRP-Il, in human whole blood. For professional use only. Relative Sensitivity for pHRP II: 98.5% Relative Sensitivity for pan LDH: 100% Relative Specificity for pHRP II: 99% Relative Specificity for pan LDH: 99% Pack Size: 10 Tests

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Rapid Test

Malaria Pan/ Pf Antigen Test is an in vitro diagnostic rapid test based on the principle of immunochromatography on a membrane, for simultaneous and differential detection of Pan LDH antigens of Plasmodium vivax, Plasmodium falciparum, Plasmodium ovale and Plasmodium malariae and Plasmodium falciparum HRP-II, in human whole blood. For professional use only. Relative Sensitivity for pHRP II: 98.5% Relative Sensitivity for pan LDH: 100% Relative Specificity for pHRP II: 99% Relative Specificity for pan LDH: 99% Pack Size: 50 Tests

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Intended Use The 4th Generation HCV TRI-DOT is a rapid, visual, sensitive and qualitative in vitro diagnostic test for the detection of (IgM,IgG & IgA) antibodies to Hepatitis C virus in human serum or plasma. It has been developed and designed with increased sensitivity for core and NS3 antibodies using a unique combination of modified HCV antigen. Salient Features Based on “Flow Through Technology”, which is similar to Elisa technology because of involvement of washing steps at various levels to enhance the specificity. Use of highly purified HCV antigens for Core, NS3, NS4, NS5 immobilized on the device. Detection of all the subtypes of HCV. Results within 3 minutes. In built quality control dot which validates the test. 100% Sensitivity & 98.9% Specificity as per WHO evaluation. Shelf life : 24 months at 2-8°C

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Rapid Test

Intended Use Diagnos Dengue card is a rapid solid phase Immuno-chromatographic test for the qualitative differential detection of IgM and IgG antibodies to dengue virus in Human serum /Plasma. This test is for in vitro diagnostic use only and is intended as an aid in for presumptive diagnosis between primary and secondary dengue infection. Salient Features Rapid, visual and qualitative Immunoassay. Differential detection of IgM & IgG Antibodies. Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4). See through device for easy interpretation of results. Unique sample processing method ensures highest accuracy in results. Results with in 20 minutes. Longer shelf life : 30 months at 2-30°C. Convenient pack size : 10 tests Sensitivity-95% and Specificity- 97%. Principle

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