ACCESS BIO

CareStart™ COVID-19 IgM/IgG

Rapid test for antibodies to the SARS-CoV-2 Virus

The CareStart™ COVID-19 IgM/IgG is a CE-approved, lateral flow immuno-chromatographic assay for the detection of SARS-CoV-2 IgM/IgG antibodies in human blood specimens. This test differentiates IgM and IgG specific to SARS-CoV-2 in a single test within 10 minutes.

CareStart™ COVID-19 IgM/IgG is manufactured by Access-bio Inc, an industry leading diagnostics business.

CareStart Antibody Test
  • Detect and differentiate IgM/IgG antibody specific to SARS-CoV-2
  • Fast and easy to use in CLIA certified laboratories
  • Requires a small sample volume (10 uL of whole blood, serum, or plasma)
  • No special equipment or training required. Results in 10 minutes
  • Overall clinical performance: 100% sensitivity and 97.5% specificity
  • Manufactured Entirely in the U.S. by a U.S. Headquartered Company

The CareStart™ COVID-19 IgM/IgG antibody test has not been FDA cleared or approved. This test has been authorized by the FDA under a 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 the 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.

(1) Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. (2) Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.(3) 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. (4) Not for the screening of donated blood.

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