Inna Sekirov1, Vilte E Barakauskas2, Janet Simons3, Darrel Cook4, Brandon Bates2, Laura Burns2, Shazia Masud5, Marthe Charles6, Meghan McLennan7, Annie Mak4, Navdeep Chahil4, Rohit Vijh8, Althea Hayden8, David Goldfarb2, Paul N Levett1, Mel Krajden1, Muhammad Morshed9. 1. BCCDC Public Health Laboratory, BC Centre for Disease Control, Vancouver BC, Canada; Pathology and Laboratory Medicine, University of British Columbia, Vancouver BC, Canada. 2. Pathology and Laboratory Medicine, University of British Columbia, Vancouver BC, Canada; BC Children's and Women's Hospital, Vancouver BC, Canada. 3. BC Children's and Women's Hospital, Vancouver BC, Canada; Department of Laboratory Medicine, Providence Health Care, Vancouver BC, Canada. 4. BCCDC Public Health Laboratory, BC Centre for Disease Control, Vancouver BC, Canada. 5. Pathology and Laboratory Medicine, University of British Columbia, Vancouver BC, Canada; Surrey Memorial Hospital, Surrey BC, Canada. 6. Pathology and Laboratory Medicine, University of British Columbia, Vancouver BC, Canada; Vancouver General Hospital, Vancouver BC, Canada. 7. Provincial Health Services Authority, Vancouver BC, Canada. 8. Vancouver Coastal Health, Vancouver BC, Canada. 9. BCCDC Public Health Laboratory, BC Centre for Disease Control, Vancouver BC, Canada; Pathology and Laboratory Medicine, University of British Columbia, Vancouver BC, Canada. Electronic address: Muhammad.Morshed@bccdc.ca.
Abstract
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 LIAISONTM SARS-CoV-2 S1/S2 IgG; 2) Abbott ARCHITECTTM SARS-CoV-2 IgG; 3) Ortho VITROSTM Anti-SARS-CoV-2 Total; 4) VITROSTM Anti-SARS-CoV-2 IgG; 5) Siemens SARS-CoV-2 Total Assay; and 6) Roche ElecsysTM 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%.
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 LIAISONTM SARS-CoV-2 S1/S2 IgG; 2) Abbott ARCHITECTTM SARS-CoV-2 IgG; 3) Ortho VITROSTM Anti-SARS-CoV-2 Total; 4) VITROSTM Anti-SARS-CoV-2 IgG; 5) Siemens SARS-CoV-2 Total Assay; and 6) Roche ElecsysTM 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%.
Authors: Alison A Lopez; Mona Patel; Jonathan H Rayment; Herman Tam; Ashley Roberts; Samara Laskin; Lori Tucker; Catherine M Biggs Journal: Paediatr Child Health Date: 2022-09-08 Impact factor: 2.600
Authors: Halie M Rando; Christian Brueffer; Ronan Lordan; Anna Ada Dattoli; David Manheim; Jesse G Meyer; Ariel I Mundo; Dimitri Perrin; David Mai; Nils Wellhausen; Covid-Review Consortium; Anthony Gitter; Casey S Greene Journal: ArXiv Date: 2022-04-26
Authors: Alison A Lopez; Mona Patel; Jonathan H Rayment; Herman Tam; Ashley Roberts; Samara Laskin; Lori Tucker; Catherine M Biggs Journal: Paediatr Child Health Date: 2022-04-28 Impact factor: 2.600