Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
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Comparative Study
Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detection.
COVID-19 pandemic has spread worldwide since December 2019. Serological tests for SARS-CoV-2 antibody testing are needed for detection of current or past infections. A wide range of commercial tests is available. However, most of them need to be validated. ⋯ Commercial serological tests are useful for detection of antibodies in patients with COVID-19. ELISA presented better results than LFI. The results allowed to incorporate the most sensitive LFI to the daily workflow, combining with ELISA. Careful validation is encouraged before clinical laboratories start using these tests.
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Serological SARS-CoV-2 assays are urgently needed for diagnosis, contact tracing and for epidemiological studies. So far, there is limited data on how recently commercially available, high-throughput immunoassays, using different recombinant SARS-CoV-2 antigens, perform with clinical samples. Focusing on IgG and total antibodies, we demonstrate the performance of four automated immunoassays (Abbott Architect™ i2000 (N protein-based)), Roche cobas™ e 411 analyzer (N protein-based, not differentiating between IgA, IgM or IgG antibodies), LIAISON®XL platform (S1 and S2 protein-based), VIRCLIA® automation system (S1 and N protein-based) in comparison to two ELISA assays (Euroimmun SARS-CoV-2 IgG (S1 protein-based) and Virotech SARS-CoV-2 IgG ELISA (N protein-based)) and an in-house developed plaque reduction neutralization test (PRNT). ⋯ This should be further analysed. The specificity of the examined assays was ≥ 97%. However, because of the low or unknown prevalence of SARS-CoV-2, the examined assays in this study are currently primarily eligible for epidemiological investigations, as they have limited information in individual testing.
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The recent outbreak of coronavirus disease 2019 (COVID-19) has spread worldwide, with especially severe epidemics occurring in cities across China. ⋯ The COVID-19 infection was of clustering onset and can cause severe respiratory disease and even death. The mortality of ICU patients with COVID-19 was considerably high.
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Comparative Study
Comparison of a laboratory-developed test targeting the envelope gene with three nucleic acid amplification tests for detection of SARS-CoV-2.
Numerous nucleic acid amplification tests, including real-time, reverse transcription PCR (rRT-PCR) and isothermal amplification methods, have been developed to detect SARS-CoV-2 RNA, including many that have received emergency use authorization (EUA). There is a need to assess their test performance relative to one another. ⋯ Performance was comparable among the SARS-CoV-2 nucleic acid amplification methods tested, with a limited number of discrepancies observed in specimens with low viral loads.