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COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test

utilizing lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.

  • Clinical Evaluation
    • Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%
    • Negative  Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%
  • Clinical Agreement with Characterized Samples
    • Sensitivity: IgG 96.7%; IgM 100%; Combined 100%​
    • Specificity: IgG 97.5%; IgM 100%; Combined 97.5%​
  • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 10 minutes
  • Shelf Life: 24 months from the date of manufacture


Can I freeze the device for long-term storage?

The device should never be frozen. If refrigerated, allow the buffer, specimen and device to reach room temperature before use.

What is the significance of the various test results?

IgM negative, IgG negative: 

Patient not exposed or too early. A medical professional should observe symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.

IgM positive, IgG positive/negative: 

Acute or recent infection.

IgM negative, IgG positive:

Previous, distant infection.

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.

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

Performance Data*

AntibodyPerformance Measure Estimate of Performance 95% Confidence Interval
lgMSensitivity100% (30/30) (88.7%; 100%)
lgM Specificity 98.8% (79/80) (93.3%; 99.8%)
lgGSensitivity90.0% (27/30) (74.4%; 96.5%)
lgGSpecificity 100% (80/80) (95.4%; 100%)
CombinedSensitivity100% (30/30) (88.7%; 100%)
CombinedSpecificity98.8% (79/80) (93.3%; 99.8%)
CombinedPPV per prevalence = 5% 80.8% (40.9%; 96.0%)
CombinedNPV per prevalence = 5% 100% (99.4%; 100%)