Antibody Identification and Differentiation

Identify and differentiate IgG and IgM antibodies to confirm past or current exposure to SARS-CoV-2 and provide qualitative information to complement molecular studies.

  • Identify SARS-CoV-2 IgG – IgG is produced in later stages of the infection and can indicate recent or prior infection
  • Identify SARS-CoV-2 IgM – IgM is an acute phase marker and is the first antibody produced by the immune system in response to an infection
  • Differentiate – Monitor seroconversion and immunological status of patients by providing IgG and IgM specific results

Rapid Results

Rapid test technology enables health care systems to meet the increase in testing demands to aid in the diagnosis of COVID-19

  • Quck Results – Results can be read in 15 minutes
  • Simple procedure – A simple 3-step procedure requires addition of the patient sample, buffer, and then read results after 15 minutes
  • Versatile sample type – Sample types includes venous whole blood (one drop), serum (5 µL), and plasma (5 µL)

The time kinetics of antibodies isotypes produced against SARS-CoV-2 compared with PCR

Adapted from different publications on the trend of SARS-CoV-2 positives in relation to the antibody titer IgG, and IgM with PCR of molecular tests.1,7

Related Documents

Assure Fastep COVID-19
Rapid Test Kit

Instruction for Use
(IFU – US Only)

 Download >
Assure Fastep COVID-19
Rapid Test Kit

Fact Sheet for Healthcare Providers
(US Only) Download >
Assure Fastep COVID-19
Rapid Test Kit

Fact Sheet for Healthcare Receipts
(US Only) Download >
Assure Fastep COVID-19
Rapid Test Kit

Emergency Use Authorization
(EUA – US Only)


Download >
Assure Fastep COVID-19
Rapid Test Kit

NCI's Frederick National Laboratory for Cancer Research Evaluation Report
(US Only) Download >
Assure Fastep COVID-19
Rapid Test Kit

Point-of-Care (POC) Quick Reference Card
(US Only)


 Download >

References:

  1. Guo L, et al. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Mar 21. [Epub ahead of print]
  2. Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff [Internet]. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Devices and Radiological Health. [Cited 2020 April 23]. Available from: https://www.fda.gov/media/135659/ download
  3. Zhao J, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. 2020 Mar 28. [Epub ahead of print]
  4. Long Q-X, et al. Antibody responses to SARS-CoV-2 in COVID-19 patients: the perspective application of serological tests in clinical practice. Clin Infect Dis. 2020 Mar 28. [Epub ahead of print]
  5. IDSA COVID-19 Antibody Testing Primer. [Internet]. Infectious Disease Society of America. [Cited 2020 April 22]. Available from: https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody-testing-primer.pdf
  6. Padoan A, et al. IgA-Ab response to spike glycoprotein of SARS-CoV-2 in patients with COVID-19: A longitudinal study. Clin Chim Acta. 2020 Apr 25. [Epub ahead of print]


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.