Description
*This product is only available to purchase by licensed physicians, clinics and other authorized professionals and institutions. This product is not for home use.
**CLIA verification required for all purchases
Please email our Sales Team at [email protected] for pricing and order requirements
>99% and >97% accuracy for COVID IgM and IgG antibody detection.
10-minute fingerprick test.
The FaStep COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test is a rapid lateral flow chromatography 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 or serum. The FaStep COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Each box contains 20 tests.
Performance Data
| Antibody | Performance Measure | Estimate of Performance | 95% Confidence Interval |
|---|---|---|---|
| lgM | Sensitivity | 93.7% (74/79) | (86.0%; 97.3%) |
| lgM | Specificity | 99.1% (225/227) | (98.6%; 99.8%) |
| lgG | Sensitivity | 98.8% (82/83) | (93.5%; 98.8%) |
| lgG | Specificity | 98.7% (224/227) | (96.2%; 99.5%) |
Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.
This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Warning
▪ This test has not been FDA cleared or approved;
▪ This test has been authorized by FDA under an EUA for use by authorized laboratories;
▪ 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.
Reviews
There are no reviews yet.