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10.1016/j.jcv.2021.104914

http://scihub22266oqcxt.onion/10.1016/j.jcv.2021.104914
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suck abstract from ncbi


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pmid34304088      J+Clin+Virol 2021 ; 142 (ä): 104914
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  • SARS-CoV-2 serology: Validation of high-throughput chemiluminescent immunoassay (CLIA) platforms and a field study in British Columbia #MMPMID34304088
  • Sekirov I; Barakauskas VE; Simons J; Cook D; Bates B; Burns L; Masud S; Charles M; McLennan M; Mak A; Chahil N; Vijh R; Hayden A; Goldfarb D; Levett PN; Krajden M; Morshed M
  • J Clin Virol 2021[Sep]; 142 (ä): 104914 PMID34304088show ga
  • BACKGROUND: SARS-CoV-2 antibody testing is required for estimating population seroprevalence and vaccine response studies. It may also increase case identification when used as an adjunct to routine molecular testing. We performed a validation study and evaluated the use of automated high-throughput assays in a field study of COVID-19-affected care facilities. METHODS: Six automated assays were assessed: 1) DiaSorin LIAISON(TM) SARS-CoV-2 S1/S2 IgG; 2) Abbott ARCHITECT(TM) SARS-CoV-2 IgG; 3) Ortho VITROS(TM) Anti-SARS-CoV-2 Total; 4) VITROS(TM) Anti-SARS-CoV-2 IgG; 5) Siemens SARS-CoV-2 Total Assay; and 6) Roche Elecsys(TM) Anti-SARS-CoV-2. The validation study included 107 samples (42 known positive; 65 presumed negative). The field study included 296 samples (92 PCR positive; 204 PCR negative or not PCR tested). All samples were tested by the six assays. RESULTS: All assays had sensitivities >90% in the field study, while in the validation study, 5/6 assays were >90% sensitive and DiaSorin was 79% sensitive. Specificities and negative predictive values were >95% for all assays. Field study estimated positive predictive values at 1-10% disease prevalence were 100% for Siemens, Abbott and Roche, while DiaSorin and Ortho assays had lower PPVs at 1% prevalence, but PPVs increased at 5-10% prevalence. In the field study, addition of serology increased diagnoses by 16% compared to PCR testing alone. CONCLUSIONS: All assays evaluated in this study demonstrated high sensitivity and specificity for samples collected at least 14 days post-symptom onset, while sensitivity was variable 0-14 days after infection. The addition of serology to the outbreak investigations increased case detection by 16%.
  • |*COVID-19[MESH]
  • |*SARS-CoV-2[MESH]
  • |Antibodies, Viral[MESH]
  • |British Columbia[MESH]
  • |Humans[MESH]
  • |Immunoassay[MESH]
  • |Sensitivity and Specificity[MESH]


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