COVID-19 “Coronavirus” IgG/IgM Rapid Test Kit
What is Coronavirus?
Coronaviruses are a large family of viruses that are common in many different species of animals, including camels, cattle, cats, and bats.
The two highly pathogenic viruses, SARS-CoV and MERS-CoV, cause a severe respiratory syndrome in humans, and the other four human coronaviruses (HCoV-NL63, HCoV-229E, HCoV-OC43, and HKU1) induce only mild upper respiratory diseases in immunocompetent hosts, although some of them can cause severe infections in infants, young children, and elderly individuals.
What Does the COVID-19 IgG/IgM Rapid Test Device Detect?
The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-s IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma as an aid in the diagnosis of primary and second SARS-COV-2 infections.
Relative sensitivity: 93.7%
Relative specificity: 99.1%
Overall agreement: 97.7%
*95% Confidence Interval
Relative sensitivity: 98.8%
Relative specificity: 98.7%
Overall agreement: 98.7%
*95% Confidence Interval
04/09/2020: Lab Update: FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations
Level: Laboratory Update
FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations
The U.S. Food and Drug Administration (FDA) recently clarified that, when it grants an Emergency Use Authorization (EUA) for a point-of-care test, that test is deemed to be CLIA-waived. For the duration of the national emergency declaration for COVID-19, such tests can be performed in any patient care setting that operates under a CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation.
In addition, FDA clarified that tests for SARS-CoV-2 that are offered prior to or without an EUA have not been reviewed by FDA, are not FDA authorized, and have not received a CLIA categorizationexternal icon. Thus, those tests are considered high complexity by default until they receive an EUA or other FDA approval that indicates they may be performed as moderate complexity or waived tests.
For more information, visit this FDA Web pageexternal icon, navigate to the section titled “General FAQs,” and view the first two questions and their corresponding answers.
- Clinical Laboratory Improvement Amendments (CLIA)
- Clinical Laboratory COVID-19 Response Weekly Calls
- CDC COVID-19 Information for Laboratories
- CDC COVID-19 Website
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address to sign up.
Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)
Covid-19 IgG/IgM Rapid Test Instructions for Use
- Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
- Place the test device on a clean and level surface.
- (For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.(For Serum or Plasma Specimens): With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
- Wait for the colored line(s) to appear. After 2 minutes, if the red color has not moved across the test window or if blood is still present in the specimen well (S), add 1 additional drop of the sample buffer to the buffer well (B).
- The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.
For IgM detection:
|COVID-19 IgG/IgM Rapid Test||IgM+||74||2||76|
For IgG detection:
|COVID-19 IgG/IgM Rapid Test||IgG+||82||3||85|