- AllTest™ 2019-nCoV IgG/IgM Rapid Test Cassette Package Insert
- INCP-402 AllTest Clinical Study Report (cassettes)
- Press Release: CLC Now Offers COVID-19 Rapid Screen Antibody Test
- MSDS-2019-nCoV IgG/IgM Rapid Test cassette
- MSDS-2019-nCoV IgG/IgM Rapid Test buffer
- FDA Guidance – Policy for Diagnostic Tests for COVID-19 during the Public Health Emergency
- Emergency Use Test Purchase Agreement
- Part Number: INCP-402
- Sample Types: Whole Blood, Serum, Plasma.
- 25 cassettes per kit.
- Results ready in 10 minutes.
- Not for home use. This is a medical device for prescription use only.
MSP 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.”
MSP 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.