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'99 relative specificity'

Items tagged with '99 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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Rapid Test

Intended Use Dengue NS1 Antigen FP is a rapid solid phase immuno- chromatographic test for the qualitative detection of Dengue NS1 Antigen in human Whole Blood/ Serum/ Plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of dengue infection. Salient Features Rapid ,visual test for the qualitative detection of Dengue NS1 Antigen in whole blood/serum/Plasma. Sample can be taken from Finger prick and sample required is 4µl. Based on Sandwich principle. Detection of Dengue in Seronegative stage i.e From Day 1 of fever. Detection of all 4 serotypes of dengue virus. Reliable diagnosis of both primary and secondary infection. 100% Sensitivity & 99.96 % Specificity. Shelf life: 24 month at 2-30 °C Convenient pack Size: 10 Test. Evaluated By Referral Medical college / Hospitals /Research institutes / Labs.

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Rapid Test

Intended Use Diagnos Celiac Card is a visual, rapid, sensitive and accurate one step immunoassay for the qualitative detection of anti tTG IgA, IgG & IgM antibodies in Human Serum or Plasma. The assay is intended to be used as an aid in the recognition and diagnosis of Celiac disease. Salient Features Rapid, Visual and Qualitative Antibody Test. Excellent Sensitivity: 99.26% & Specificity: 99.50%. Results within 20 minutes. Long Shelf life 24 months at 2-8°C. Bio-hazard free, fully covered, see-through Device. No instrument required.

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Rapid Test

ntended Use The 4th Generation DIAGNOS HCV BI-DOT is a visual, rapid, sensitive and qualitative in vitro diagnostic test for the detection of (IgM,IgG & IgA) antibodies to Hepatitis C Virus in human serum or plasma. The 4th Generation DIAGNOS HCV BI-DOT has been developed and designed with increased sensitivity for core and NS3 antibodies using a unique combination of modified HCV antigens. Salient Features Rapid ,visual 4th generation test. Based on Flow Through Technology. Use of unique combination of Core, NS3, NS4, NS5 antigen. Detects all the subtypes of HCV. Result with in 3 min. Shelf life : 24 months at 2-8°C. Sensitivity- 100 %. Specificity- 99.8 %.

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Rapid Test

Intended Use Advantage Leptospira IgM & IgG card is visual, rapid, sensitive and qualitative immunoassay for the detection of Leptospira specific IgM & IgG antibodies in human serum or plasma. Salient Features Rapid qualitative test for differential detection of Leptospira specific IgM and IgG Antibodies in Human serum/plasma. One step test procedure, add sample & read results Infection free see through device. Results with in 20 minutes. Shelf life of 30 months at 2-30°C. Excellent Sensitivity- 99 % and Excellent Specificity- 99.5%

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