QIAreach SARS-CoV-2 Antigen Test
- Results in 2–15 minutes
- Test up to 8 patients simultaneously on each eHub
- Walkaway and random access
- Digital and connected
- 90% test sensitivity, 100% test specificity
The QIAreach SARS-CoV-2 Antigen Test (CoV2 Ag) is a rapid, digital lateral flow diagnostic assay, using nanoparticle fluorescence, intended for qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal specimens collected in selected transport media from individuals who are suspected of COVID-19 by their healthcare provider.
The QIAreach SARS-CoV-2 Antigen Test has been validated but FDA’s independent review of this validation is pending.
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, to perform high complexity tests.
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Cat No./ID:646533 QIAreach SARS-CoV-2 Antigen Test Log in to see pricing 60 CoV2 Ag eSticks / Processing Tubes; 2 x 10 ml CoV2 Ag Diluent Buffer |
Cat No./ID:9003092 QIAreach eHub Device $1,199.00 QIAreach eHub, power adaptor, USB connector cable and service agreement |
Product Details
Test sensitivity
Sensitivity was estimated by evaluating health care professional-collected nasopharyngeal swab samples in BD Universal Viral Transport (UVT) (cat. no. 220527) and Remel M4RT (cat. no. R12552) transport media from study subjects with RT-PCR-confirmed symptomatic SARS-CoV-2 infection at the time of sampling. A total of 30 previously collected samples from 30 subjects were tested using the CoV2 Ag system.
Table 1 describes the clinical sensitivity at initial CoV2 Ag testing and after the discordant sample testing (testing with a second RT-PCR test) and removal of 1 false negative sample that did not agree with the reference method result.
Table 1. Clinical sensitivity by time of sampling
| Number of samples tested | Number of CoV2 Ag positive results | Positive percent agreement | 95% confidence interval | |
| After initial testing | 30 | 27 | 90.00% | 73.47‑97.89% |
| After discordant sample testing | 29 | 27 | 93.10% | 77.23‑99.15% |
The post discordant sample testing sensitivity was 93.10% (95% confidence interval: 77.23–99.15%).
For detailed clinical performance information, consult the QIAreach SARS-CoV-2 Antigen Test Instructions for Use.
Test sensitivity by Ct value range
For all reference method positive samples, the clinical sensitivity of the CoV2 Ag was stratified below by cycle threshold (Ct) value range for the SARS-CoV-2 N1 and N2 genes (across both Ct values for each subject).
Table 2. Clinical sensitivity by reference method Ct value range
| Number of positive results | |||
| Ct value range | Reference method | CoV2 Ag | Sensitivity |
| ˂11 | 1 | 1 | 100.00% |
| 11 ≤ Ct ˂ 21 | 13 | 13 | 100.00% |
| 21 ≤ Ct ˂ 31 | 9 | 9 | 100.00% |
| ≥31 | 6* | 4* | 66.67% |
* Before the exclusion of the 1 false negative sample, the sensitivity of CoV2 Ag is 57.14% (4 CoV2 Ag positive samples agree with the 7 reference method positive samples whose Ct values are ≥31).
Test specificity
Specificity was estimated by evaluating health care professional-collected nasopharyngeal swab samples in BD Universal Viral Transport (UVT) (cat. no. 220527) and Remel M4RT (cat. no. R12552) transport media from RT-PCR-confirmed negative study subjects collected after and prior to the start of the SARS-CoV-2 pandemic (on or after December 1, 2019 and before December 1, 2019, respectively). A total of 30 previously collected (banked) samples from 30 subjects were tested using the CoV2 Ag system. The following table shows the clinical specificity.
Table 3. Clinical specificity
| Number of samples tested | Number of CoV2 Ag negative results | Negative percent agreement | 95% confidence interval |
| 30 | 30 | 100% | 88.43-100.00% |
The QIAreach SARS-CoV-2 Antigen Test is a rapid, digital lateral flow diagnostic assay that detects nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab (NPS) specimens in selected transport media, from individuals who are suspected of COVID-19 or who are at high risk of SARS-CoV-2 infection.
Viral antigen detection is measured on a single-use, lateral flow, digital detection cartridge (eStick) via nanoparticle fluorescence. The eStick contains state-of-the-art optoelectronic technology and a microprocessor that converts a fluorescent signal into a qualitative readout for the presence of SARS-CoV-2 specific antigen in patient test samples.
The CoV2 Ag test is performed by inserting the CoV2 Ag eStick into a QIAreach eHub (sold separately). The QIAreach eHub is a connection hub that provides power to perform multiple CoV2 Ag tests simultaneously. The eHub acts as a power source and features a rechargeable lithium battery to allow CoV2 Ag tests to be performed when a continuous power supply is not available.
CoV2 Ag test results are determined as Positive or Negative according to the assay result algorithm on the eStick firmware.
Optional use software is available to backup test results, generate test reports, and support data transfer.
For detailed instructions for use, refer to the QIAreach SARS-CoV-2 Antigen Test Instructions for Use.
