Products listed on our website may require specific CLIA certifications (waived or moderate to high complexity) which we will need to verify prior to shipping products that fall in these categories.
>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.
|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%)|
Authorized for use only in-patient care settings operating under a CLIA Certificates of Waiver, Compliance, or Accreditation. This product can only be sold to healthcare facilities, practitioners, institutions, or qualified research or screening organizations. Testing is not for home use and is intended to be administered by a trained healthcare professional.
We will contact you to verify your healthcare provider credentials prior to shipping. Please do not order this product if you are not a licensed healthcare provider or laboratory as we will have to cancel your order.