Product Information
Product Code: COV-13C25
Sample: Whole Blood / Serum / Plasma
Format: Cassette
Quantity: 25 Tests/Kit
Specificity: COVID-19 virus IgG and IgM antibody
Time to result: 15 minutes
Storage Condition: 2-30°C/36-86°F
Test Principle: Lateral Flow Immunoassay
Contents
25 Test Cassettes
Disposable Pipettes
Buffer
Product Insert

Product Description

The Rapid Response COVID-19 IgG/IgM Test Cassette is a rapid, qualitative test for the detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG antibodies in human whole blood, serum, or plasma samples, as an aid in the diagnosis of COVID-19 disease. Interpretation of test results are positive (two lines or three lines) and negative (one line). Available for sale to healthcare professionals in United States and Europe (CE marked). Health Canada approval pending for diagnostic use.

French version/version fran├žaise

Notes for Clinical use in the United States:

On May 11, 2020 the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. The updated policy can be viewed by clicking here. Pursuant to Section IV.D of this policy, BTNX Inc. continues to distribute this test for use in CLIA high complexity laboratory settings, until the EUA application for COV-13C25 is approved for use in other settings.

This test is for professional in vitro diagnostic use only. Read the product insert prior to use. Directions should be read and followed carefully.

Laboratories and healthcare providers must include this information in their patient test report as specified in FDA guidance:

  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • Not for the screening of donated blood.

For more information, please contact covid19@btnx.com.

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