Access Anti-SARS-CoV-2 Total
For the rapid, qualitative detection of total antibodies to SARS-CoV-2
The Access 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 Access 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.
Access 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.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
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 Access CoV2T 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
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
The Access Anti-SARS-CoV-2 Total Test (Anti-CoV2) 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 Access eHub (sold separately). The Access 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.
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