HEALGEN Covid-19 Rapid Test
Healgen COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood / Serum / Plasma) The Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) received the Emergency Use Authorization from the FDA last Friday, May 29th, 2020. It is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood (Li+ heparin, K2EDTA and sodium citrate), or serum. At this time is the only FDA EUA serology rapid test kit available in Puerto Rico. |
➤ The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes.
➤ Independent Clinical Agreement Validation.
➤ Independent Clinical Agreement Validation.
Measure
IgM Sensitivity IgG Sensitivity (IgM+ or IgG+; Total) Sensitivity (PPA) (IgM-/IgG-; Total) Specificity (NPA) |
Estimate
100% (30/30) 96.7% (29/30) 100% (30/30) 97.5% (78/80) |
Confidence Interval
(88.7%; 100%) (83.3%; 99.4%) (88.7%; 100%) (91.3%; 99.3%) |
Notes: The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.
Warning
➤ This test has been authorized by FDA under an EUA for use by authorized laboratories.
➤ This test has not been FDA cleared or approved.
➤ This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
➤ This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
➤ 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.
➤ This product is intended for professional use and not for home use.
➤ Not for the screening of donated blood.
Warning
➤ This test has been authorized by FDA under an EUA for use by authorized laboratories.
➤ This test has not been FDA cleared or approved.
➤ This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
➤ This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
➤ 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.
➤ This product is intended for professional use and not for home use.
➤ Not for the screening of donated blood.