{"id":38435,"date":"2020-07-22T07:19:11","date_gmt":"2020-07-22T07:19:11","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=38435"},"modified":"2020-07-23T18:05:01","modified_gmt":"2020-07-23T18:05:01","slug":"leading-sars-cov-2-antibody-tests-meet-specificity-but-fail-current-sensitivity-guidelines","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/38435","title":{"rendered":"Leading SARS-CoV-2 antibody tests meet specificity but fail current sensitivity guidelines"},"content":{"rendered":"

<\/span><\/b>Simon Collins, HIV i-Base<\/strong><\/p>\n

A 30-page report from Public Health England (PHE) found that four leading SARS-CoV-2 antibody tests \u2013 from Abbott, DiaSorin, Roche, and Siemens \u2013 met criteria for specificity, but that only the Siemens test also met requirements for sensitivity.<\/strong><\/p>\n

The study by independent researchers at the University of Oxford and Oxford University Hospitals NHS Foundation Trust was commissioned by the Department of Health and Social Care (DHSC).<\/p>\n

Sensitivity was tested on 536 positive samples from adults with laboratory-confirmed SARS-CoV-2 infection at >20 days post-symptom onset. Specificity was tested on 994 pre-pandemic (2015-2018) specimens from unique, healthy adults.<\/p>\n

Primary results are shown in Table 1.<\/p>\n

In order for all four tests to meet sensitivity criteria, specificity thresholds needed to be optimized to >98% and the sample timeframe extended to >30 days post-symptom onset.<\/p>\n

Table 1: Sensitivity and specificity of four commercial SARS-CoV-2 antibody tests<\/strong><\/p>\n\n\n\n\n\n\n\n
Assay <\/strong><\/td>\nSensitivity
\n<\/strong>[95% CI] <\/strong><\/td>\n		Specificity
\n[95% CI] <\/strong><\/td>\n		Appraisal against MHRA target product profile (TPP) <\/strong><\/td>\n<\/tr>\n
\u00a0Abbott<\/td>\n\u00a092.7 (90.2, 94.8)<\/td>\n\u00a099.9 (99.4, 100)<\/td>\n\u00a0Meets specificity criterion<\/td>\n<\/tr>\n
\u00a0DiaSorin<\/td>\n\u00a095.0 (92.8, 96.7)<\/td>\n\u00a098.6 (97.6, 99.2)<\/td>\n\u00a0Meets specificity criterion<\/td>\n<\/tr>\n
\u00a0Roche<\/td>\n\u00a097.2 (95.4, 98.4)<\/td>\n\u00a099.8 (99.3, 100)<\/td>\n\u00a0Meets specificity criterion<\/td>\n<\/tr>\n
\u00a0Siemens<\/td>\n\u00a098.1 (96.6, 99.1)<\/td>\n\u00a099.9 (99.4, 100)<\/td>\n\u00a0Meets sensitivity and specificity criteria<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Reference<\/p>\n

PHE. Evaluation of sensitivity and specificity of four commercially available SARS-CoV-2 antibody immunoassays. (July 2020).
\nhttps:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/898437\/Evaluation__of_sensitivity_and_specificity_of_4_commercially_available_SARS-CoV-2_antibody_immunoassays.pdf<\/a> (PDF)<\/p>\n

This report was first published on 10 July 2020.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

Simon Collins, HIV i-Base A 30-page report from Public Health England (PHE) found that four leading SARS-CoV-2 antibody tests \u2013 from Abbott, DiaSorin, Roche, and Siemens \u2013 met criteria for specificity, but that only the Siemens test also met requirements …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[296,278],"tags":[],"class_list":["post-38435","post","type-post","status-publish","format-standard","hentry","category-coid-19-diagnostics","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38435","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=38435"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38435\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=38435"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=38435"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=38435"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}