Infectious Disease | COVID-19

QIAreach Anti-SARS-CoV-2 Total Test

Detect SARS-CoV-2 antibodies in 10 minutes or less

The QIAreach Anti-SARS-CoV-2 Total Test is a digital assay to detect total SARS-CoV-2 antibodies (IgA, IgG, IgM), helping you identify possible past infection.

Built on state·of-the-art nanoparticle fluorescence technology, it lets you test up to eight patients simultaneously with true walk-away capability.

Trust your test results

The QIAreach Anti-SARS-CoV-2 Total Test delivers 93.85% test sensitivity and 97.83% test specificity for reliable results you can report with confidence.

Positive Percent Agreement/Sensitivity by days post-symptom onset
Number of days after symptom onset Number of samples tested Number of QIAreach Anti-SARS-CoV-2 Total Test positive results Positive percent agreement 95% confidence interval
0-7 days 3 2 66.67% 9.43 - 99.16%
8-14 days 13 12 92.31% 63.97 - 99.81%
≥15 days
49 47 95.92% 86.02 - 99.50%
All 65 61 93.85% 84.99 - 98.30%

Negative Percent Agreement/Specificity
Number of samples tested Number of QIAreach Anti-SARS-CoV-2 Total Test negative results Negative percent agreement 95% confidence interval
230 225 97.83% 95.00 - 99.29%

Accessible SARS-CoV-2 antibody testing in action

Find out how easy it is to get started. We've provided a complete introduction to COVID-19 serology testing with the QIAreach Anti-SARS-CoV-2 Total Test – from unboxing the Kit to processing Test results.

QIAreach Anti-SARS-CoV-2 Total testing 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 has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
  • This test has been authorized only for detecting the presence of total antibodies to SARS-CoV-2, not for any other viruses or pathogens; and
  • The emergency use of 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 declaration is terminated or authorization is revoked sooner.

Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.