COVID-19 IgG/IgM Rapid Test Cassette

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COVID-19 IgG/IgM Rapid Test Cassette

46000 in stock

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood (Li+ heparin, K2EDTA and sodium citrate), or serum. For Emergency Authorization Use (EUA) only.  Please contact us for detailed product information, availability, and pricing.

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SKU: DTK-COV402a Categories: ,

Description

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.

Kit Includes
25 sealed pouches each containing a test cassette, a dropper and a desiccant
1 Buffer
1 Package insert

Features and Benefits

• Rapid results in 10 minutes (Positive results as soon as 2 minutes)
• Emergency Use Authorized for both Moderately Complex and Highly Complex Labs
• Small sample volume: only 5 µL of serum/plasma or 10 µL of whole blood
• Visual test; no analyzer needed.
• High sensitivity and specificity (summary data below )

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) product insert, authorized Fact Sheet for Healthcare Providers, authorized Fact Sheet for Recipients and additional studies are provided below:

Letter of Authorization

IDCOV402a Package Insert

Authorized Fact Sheet for HCP

Authorized Fact Sheet for Recipients

(Study) Clinical Sensitivity and Specificity of three rapid SARS-CoV-2 Antibody Tests

(Study) Evaluation of a COVID 19 IgM and IgG rapid test an efficient tool for assessment of past exposure to SARS CoV 2

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