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Infectious Disease | COVID-19

QIAreach SARS-CoV-2 Antigen Test

Detect SARS-CoV-2 infection in 15 minutes or less

The QIAreach SARS-CoV-2 Antigen Test (CoV2 Ag) is a scalable, digital assay for the in vitro detection of the SARS-CoV-2 nucleocapsid protein antigen.

THe QIAreach SARS-CoV-2 antigen test lets you test up to eight patients at once for SARS-CoV-2 infection – with results in just 2–15 minutes.

QIAreach in use

Trustworthy, reproducible results

QIAreach SARS-CoV-2 Antigen Test delivers high test sensitivity and specificity, for reliable results you can report with confidence. Test results are determined by objective measurement using proprietary nanoparticle fluorescence technology. 
Negative Percent Agreement (NPA) vs. high-sensitivity RT-PCR assay
Sample type Samples tested Negative results Negative percent agreement 95% confidence interval
Anterior nasal swab 210 208 99.05% 96.60 - 99.88%
Nasopharyngeal swab 178 175 98.31% 95.13 - 99.65%
Positive Percent Agreement (PPA) vs. high-sensitivity RT-PCR assay
Sample type Samples tested Positive results Positive percent agreement 95% confidence interval
Anterior nasal swab 60 51 85.00% 73.43–92.90%
Nasopharyngeal swab 62 50 80.65% 68.63–89.58%

Digital and connected

QIAreach SARS-CoV-2 Antigen Test provides fast testing on a digital portable device for ease of use, reliability and integrated data management without the need for centralized laboratory infrastructure. Test results are stored on the eStick and displayed on the QIAreach eHub, and the assay can be used with or without connection to a computer for optional data export to LIS.
Software, user manual and ordering information

QIAreach SARS-CoV-2 Antigen 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 product 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 product has been authorized only for the detection of proteins from 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.
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