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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% |
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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.