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'igm immunoassay'

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Immunoassay Reagents

INTENDED USE The Finecare™ 2019-nCoV lgM/lgG Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of IgG and IgM antibodies of novel coronaviruses (2019-nCoV) in human whole blood, serum and plasma specimen. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV. The test provides preliminary test results. Negative results cannot exclude the possibility of 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision. STORAGE AND STABILITY 1. Store at 4-30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

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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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Rapid Test

Intended Use Scrub Typhus (Tsutsugamushi) IgM & IgG Card is a rapid solid phase immuno-chromatographic assay for the qualitative and differential detection of IgM and IgG antibodies to Scrub Typhus antibodies in human serum / plasma. This test is for in vitro diagnostic use only and is intended as an aid to early diagnosis of Scrub Typhus infection in patient with clinical symptoms. Salient Features Rapid ,visual and qualitative Immunoassay. Differential detection of IgM & IgG antiobodies to Scrub Typhus (Tsutsugamushi) in Human Serum / Plasma. Based on Immunochromatography Technique. See through device for easy interpretation of results. Results with in 20 minutes Shelf life 30 months at 2-30°C Convenient pack size: 20T & 50T. Sensitivity & Specificity: 100% (In house Evaluation)

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Rapid Test

Intended Use Scrub Typhus IgM/IgG/IgA Card is a rapid solid phase immuno-chromatographic assay for the qualitative detection of IgM, IgG& IgA antibodies to Scrub Typhus in human serum / plasma / whole blood. This test is for in vitro diagnostic use only and is intended as an aid to early diagnosis of Scrub Typhus infection in patient with clinical symptoms. Salient Features Finger prick, rapid, visual and qualitative Immunoassay. Detection of all antibodies (IgM, IgG, IgA) to Scrub Typhus (Tsutsugamushi) in Whole blood/serum / plasma. Based on Immunochromatography Technique. See through device for easy interpretation of results. Results within 20 minutes Shelf life 30 months at 2-30°C Convenient pack size: 25 T. Sensitivity & Specificity: 100%

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Rapid Test

STANDARD F Chikungunya IgM/IgG FIA qualitatively analyzes Chikungunya virus specific IgM and IgG antibodies in serum, plasma and whole blood using fluorescent immunoassay. Screening test results can be obtained within 15 minutes with high sensitivity and specificity. Intented Use This product performs qualitative analysis on Chikungunya virus specific IgM and IgG antibodies in serum, plasma and whole blood. Advantage Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance Objective result - Eliminates the subjectivity of a visual result Automatic strip recognition by reading the information stored in 2D barcode

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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 HSV-1 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 1 (HSV-1) in human serum, plasma or whole blood. Type-specific detection by utilizing glycoprotein G1. Single test that detects and differentiates IgG and IgM anti-HSV-1. High confidence as test is in agreement with market leading ELISA test: 90.7% IgG; 85.0% 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 the 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-R0203, 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 Typhoid IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the detection and differentiation of IgG and IgM anti-Salmonella typhi (S. typhi) and paratyphi in human serum, plasma or whole blood. Utilizes O antigen and H antigen from both typhi and paratyphi serovars to maximize sensitivity Differentiates between IgG and IgM to determine stage of infection One step procedure minimizes operator error due to sample preparation Test result within 15 minutes allows medical professionals to take immediate action High level of reproducibility Test kits can be used and stored in a wide range of temperatures Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample Diluent (REF SB-R0161, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance Flyer Inserts U.S. CDC Typhoid Homepage: About Typhoid WHO: Health Topic for Typhoid

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