Latest external validation of SARS-CoV-2 rapid tests Acro Biotech
The urgent need for reliable diagnostic tests in response to COVID-19 requires laboratories to have independent external validations to facilitate the choice of the best available rapid tests. Independent and robust post-market evaluations of COVID-19 tests provide confirmation of manufacturers performance claims. The basic measures for quantifying diagnostic test performance are sensitivity and specificity.
Therefore, we share the following studies performed, in relation to validations performed by external laboratories with Acro Biotech rapid tests where the agreement between stated technical specifications and those observed in real situations can be checked. The objective of the studies performed is to measure the reliability and performance of rapid antigen tests on random clinical samples for the diagnosis of SARS-CoV2.
SARS-CoV-2 Antigen Rapid Test Validations
GERMANY
At the Biomex laboratory in Germany, they tested the specificity of the SARS-CoV-2 antigen rapid test calculated from the results of all samples, the result was 100 %, the sensitivity calculated from the results of samples with a Ct value below 32 (103 samples) was 96 % (95 % CI: 90-99 %).
FRANCE
At the University of Burgundy, four types of rapid antigen tests were used, with negative and positive VTM nasopharyngeal samples. And the sensitivity was 97.01% with Ct<26 with Acro Biotec one of the highest sensitivities of the 4 tests compared.
UK AND CANADA
In a systematic study, published in Diagnostics conducted by researchers from UK and Canada, with a review of independent studies evaluating the performance of 42 rapid tests for SARS-CoV-2 serological testing. We are proud to report that Acro Biotech, Inc. COVID-19 Rapid POC Test is among the best performing of the 42 rapid tests evaluated, with a sensitivity and specificity of 100%.
IgG-IgM Rapid Antibody Test Validations
UNITED STATES
For antibody testing we have this study from Acro Biotech. A prospective study conducted by the CDC in the United States. Each test was evaluated against frozen serum samples with antibodies against SARS-CoV-2 and negative frozen plasma samples. Of note in this study, the presence of antibodies was confirmed using ELISA developed by CDC (Pan-Ig, IgG and IgM), as well as an IgG receptor binding domain (RBD) ELISA, and the concordance of the rapid test “2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)” for the detection of <strong>anti-Spike and anti-RBD antibodies could be confirmed.
Therefore, the results indicate that Acro Biotech’s rapid tests for the diagnosis of COVID-19 are the ideal tool for when time or laboratory environment is lacking.
Acro Biotech is a California-based rapid test manufacturer offering state-of-the-art products that comply with the ISO 13485:2016 CMDCAS standard. They have a wide range of rapid tests such as drug abuse tests, cardiac markers or infectious diseases. Innovation and marketing, with the aim of introducing new products on the market that make a difference, including the combination of digitalization and the ease of rapid tests.
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