For US Only – Assure Fastep COVID-19 IgG/IgM Test Kit

Performance Data*
Antibody Performance Measure Estimate of Performance 95% Confidence Interval
lgM Sensitivity 100% (30/30) (88.7%; 100%)
lgM Specificity 98.8% (79/80) (93.3%; 99.8%)
lgG Sensitivity 90.0% (27/30) (74.4%; 96.5%)
lgG Specificity 100% (80/80) (95.4%; 100%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 98.8% (79/80) (93.3%; 99.8%)
Combined PPV per prevalence = 5% 80.8% (40.9%; 96.0%)
Combined NPV per prevalence = 5% 100% (99.4%; 100%)

*NCI's Frederick National Laboratory for Cancer Research Evaluation Report ( view report )

 


Kit Details
Part Number 741593
Quantity 20 tests
Method Lateral flow chromatographic immunoassay
Type Qualitative test
Isotypes lgG and lgM
Proteins Recombinant nucleocapsid and spike (S1)
Incubation time 15 minutes
Sample type Venous whole blood, serum, and plasma; and fingerstick whole blood
Shelf life 24 months from the date of preparation
Storage 2-30℃
External Controls
Part Number 741549
Quantity 2 negative, 1 positive
Format Lyophilized IgG/IgM against SARS-CoV-2 and lyophilized negative human serum samples
Storage Once reconstituted 2-8℃

This information is intended for physicians and healthcare professionals only.

Product registration and availability vary by country. For more information on product availability, please contact us here.

 

The Assure Fastep test kit 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
 
Use of the Assure Fastep test kit 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.