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QIAreach Anti-SARS-CoV-2 Total

For the rapid, qualitative detection of total antibodies to SARS-CoV-2
  • Total Ig detection (IgA, IgM, IgG)
  • Results in 10 minutes from plasma or serum
  • First positive results in 3 minutes
  • Test up to 8 patients simultaneously on each eHub
  • Walkaway and random access

The QIAreach Anti-SARS-CoV-2 Total Test is a rapid, digital lateral flow serological test, using nanoparticle fluorescence, intended for qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma (heparin, EDTA). The QIAreach Anti-SARS-CoV-2 Total Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

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, to perform high complexity tests.

  • This test has not been reviewed by the FDA.
  • 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.
  • 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.
  • 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.

 

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

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Cat No./ID: 645033
QIAreach Anti-SARS-CoV-2 Total Test Kit
$1,500.00
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60 Anti-CoV2 eSticks / Processing Tubes; 3 x 10 ml Anti-CoV2 Diluent Buffer

Cat No./ID: 9003092
QIAreach eHub Device
$1,000.00
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QIAreach eHub, power adaptor, USB connector cable and service agreement

Product Details

Performance

Test sensitivity was estimated by evaluating samples from study subjects with PCR-confirmed symptomatic SARS-CoV-2 infection. A total of 30 previously collected samples from 30 subjects were tested singly using the QIAreach Anti-SARS-CoV-2 Total (Anti-CoV2) system.

The following table describes the clinical sensitivity by time of sampling after onset of symptoms.

Note: No samples were tested before ≥14 days after onset of symptoms.

Table 1. Clinical sensitivity by time of sampling

Number of days after symptom onset Number of samples tested Number of Anti-CoV2 positive results Positive percent agreement 95% confidence interval
≤ 14 days 30 30 100.00% 88.43–100.00%

Test specificity was estimated by evaluating samples collected before the start of the SARS-CoV-2 pandemic (before November, 2019). A total of 75 previously collected samples from 75 subjects were tested singly using the Anti-CoV2 system. The following table shows the clinical specificity.

Table 2. Clinical specificity

Number of samples tested Number of Anti-CoV2 negative results Negative percent agreement 95% confidence interval
75 75 100.00% 95.20–100.00%
Principle

The QIAreach Anti-SARS-CoV-2 Total Test is a rapid serological test that detects total antibody responses (IgM, IgG, and IgA) to expressed SARS-CoV-2 viral antigens, in serum or plasma.

Antibody responses are 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 antibodies in patient test samples.

The Anti-CoV2 test is performed by inserting the Anti-CoV2 eStick into an QIAreach eHub (sold separately). The QIAreach eHub is a connection hub that provides power to perform multiple Anti-CoV2 tests simultaneously. The eHub acts as a power source and features a rechargeable lithium battery to allow Anti-CoV2 tests to be performed when a continuous power supply is not available. 

Anti-CoV2 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 online data transfer.

Product Resources

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Software User Guides (1)
For installation, setup, and use of Access Software version 1.01.12

Note: Access Anti-SARS-CoV-2 Total Test has been rebranded to QIAreach Anti-SARS-CoV-2 Total Test. The software manual and the software will be updated in the near future to reflect the new name.
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Kit Handbooks (1)
For in vitro diagnostic use
This test has not been reviewed by FDA.
Rx only
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Brochures & Guides (1)
This test has not been reviewed by FDA.
Not intended as an exhaustive instructional document.


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Instrument User Manuals (1)
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