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COVID-19 IgM Rapid Test Cassette (25/Test) (NON CLIA-WAIVED; FDA EUA)
COVID-19 IgM Rapid Test Cassette (25/Test) (NON CLIA-WAIVED; FDA EUA)


 
Our Price: $350.00




Product Code: IDCOV02A

Details
 
Note: This product can only ship to a medical or educational facility. This product requires a certificate of high complexity.

Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, serum and plasma. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2.

Features and Benefits
  • Emergency Use Authorized for CLIA Moderately Complex and Highly Complex labs Time to Result: 10 minutes
  • Specimen Volume: 5µL (Serum/Plasma) 10 µL (Venous Whole Blood)
  • IgG and IgM isotypes reported separately
  • Storage: 2-30°C (36-86°F)
  • Stability: 24 months
  • Comes in a package of 25

Sample Results



Interpretation of Results
  • Negative: The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.
  • IgM Positive: The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.
  • IgG Positive: The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies
  • IgM and IgG Positive: The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.
  • Invalid: Control line is partially red, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette.

Technical Specifications

Performance


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