Description
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 (sodium heparin, lithium heparin, dipotassium EDTA and tripotassium 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, 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.
Positive Percent Agreement/Sensitivity was estimated by evaluating serum and plasma samples from study subjects with PCR-confirmed symptomatic SARS-CoV-2 infection. A total of 65 previously collected samples from 65 subjects, collected from April 2020 to July 2020 in the United States (43 samples) and Peru (22 samples), were tested using the QIAreach Anti-SARS-CoV-2 Total Test. The following table describes the positive percent agreement by time of sampling after onset of symptoms. Table 1. Clinical 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 was estimated by evaluating samples collected before the start of the SARS-CoV-2 pandemic (before December 2019). A total of 230 previously collected serum and plasma samples from 230 subjects in the United States were tested using the QIAreach Anti-SARS-CoV-2 Total Test. The following table shows the negative percent agreement. Table 2. Negative Percent Agreement 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%
The QIAreach Anti-SARS-CoV-2 Total Test is a rapid, qualitative serological test that detects total antibody responses (IgM, IgG, and IgA) to expressed SARS-CoV-2 viral antigens in serum or plasma (sodium heparin, lithium heparin, dipotassium EDTA and tripotassium EDTA). Antibodies are detected 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 QIAreach Anti-SARS-CoV-2 Total Test is performed by inserting the eStick into an QIAreach eHub (sold separately). The QIAreach eHub is a connection hub that provides power to perform multiple QIAreach Anti-SARS-CoV-2 Total Tests simultaneously. The eHub acts as a power source and features a rechargeable lithium battery to allow QIAreach Anti-SARS-CoV-2 Total Tests to be performed when a continuous power supply is not available. QIAreach Anti-SARS-CoV-2 Total 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.
