COVID-19 Rapid Antibody Testing Strips:

Measuring the presence of antibodies against the virus

Product Information

  • Part Number: 70-TS2019-200
  • Sample Types: Whole Blood, Serum, Plasma.
  • Each kit contains 4 canisters of 50 test strips each.
  • Results ready in 10 minutes.

Not for home use. This is a medical device for prescription use only.

For more information, please call 1.800.445.9853 or

Intended Use Statement

The 2019-nCoV IgG/IgM Rapid Test Cassette is an in vitro diagnostic test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood (venipuncture or fingerstick), serum or plasma specimen collected in CLIA certified laboratory and/or healthcare workers at the point-of-care. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity tests.

MedTest Dx Information Statement:

On March 16, 2020, the U.S. Food and Drug Administration issued a policy update entitled “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff.”

MedTest Dx is offering the AllTest 2019-nCoV IgG/IgM Rapid Test Cassette in accordance with Section C and D, as the manufacturer’s PEUA200087 is pending review.

Subsection C of the Guidance provides that commercial manufacturers of diagnostic test kits may develop and distribute their products prior to Emergency Use Authorization submission. Significantly, the FDA Guidance provides “In light of the increasing numbers of COVID-19 cases throughout the country and the urgent need to expand the nation’s capacity for COVID-19 testing during the public health emergency, FDA does not intend to object to a commercial manufacturer’s development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time after the manufacturer’s validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website.” You may visit the Carolina Liquid Chemistries website for a copy of the package insert which contains the performance characteristics and instructions for use.

Subsection D considers that serology tests are less complex than molecular, but still regards them as high complexity and are solely used to identify antibodies to the virus. FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to the FDA, and information along the lines of the following is included in test reports:

  • This test has not been reviewed by the FDA
  • Negative results do no 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.

Following the FDA recommendation, since the manufacturer’s EUA is pending, the same statements above that are included per Subsection D should appear on test reports until the EUA is authorized.

This is a class II medical device. This device is for prescription use only and is not for home use or home specimen collection.

FDA Emergency Use Authorization

During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.

Before the FDA can issue an EUA, the Secretary of Health and Human Services must make a declaration of emergency or threat justifying authorization of emergency use for a product. This chart summarizes the process for EUA issuance.

When the emergency is over, the EUA declaration is terminated, and all EUAs issued based on that declaration will no longer remain in effect.

FAQ’s

1. Is it a Covid-19 test or a Sars-CoV-2 test?

The disease is called Covid-19 and the virus is Sars-CoV-2. The test can only measure the presence of antibodies against the virus (commonly called the Covid-19 virus) and is not a diagnostic for the Covid-19 disease.

2. If antibody tests are not used for diagnosis or exclusion of COVID-19 infection, what is their purpose?

Serology or antibody tests can play a critical role by helping healthcare professionals identify individuals who have been exposed to SARS-CoV-2 virus and have developed an immune response. this can potentially be used to help determine, together with other clinical data, whether these individuals may be less susceptible to infection.

3. Is this test CLIA waived?

No, it must be used in a Highly Complex setting.

4. Can blood from a fingerstick be used?

Yes, fingerstick blood can be used.

5. Can the test be run with saliva or a nasal swab?
No

 

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