About: Point-of-care serological assays for delayed SARS-CoV-2 case identification among health-care workers in the UK: a prospective multicentre cohort study

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About: Point-of-care serological assays for delayed SARS-CoV-2 case identification among health-care workers in the UK: a prospective multicentre cohort study Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Point-of-care serological assays for delayed SARS-CoV-2 case identification among health-care workers in the UK: a prospective multicentre cohort study
Creator	Gilmour, Kimberly Jones, Rachael Scott, Christopher Charani, Esmita Mai, Annabelle Moore, Luke Mughal, Nabeela Pallett, Scott Randell, Paul Rayment, Michael Davies, Gary Denny, Sarah Fitzgerald-Smith, Sophia Hatcher, James Patel, Aatish
Source	Elsevier; Medline; PMC
abstract	BACKGROUND: Health-care workers constitute a high-risk population for acquisition of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Capacity for acute diagnosis via PCR testing was limited for individuals with mild to moderate SARS-CoV-2 infection in the early phase of the COVID-19 pandemic and a substantial proportion of health-care workers with suspected infection were not tested. We aimed to investigate the performance of point-of-care and laboratory serology assays and their utility in late case identification, and to estimate SARS-CoV-2 seroprevalence. METHODS: We did a prospective multicentre cohort study between April 8 and June 12, 2020, in two phases. Symptomatic health-care workers with mild to moderate symptoms were eligible to participate 14 days after onset of COVID-19 symptoms, as per the Public Health England (PHE) case definition. Health-care workers were recruited to the asymptomatic cohort if they had not developed PHE-defined COVID-19 symptoms since Dec 1, 2019. In phase 1, two point-of-care lateral flow serological assays, the Onsite CTK Biotech COVID-19 split IgG/IgM Rapid Test (CTK Bitotech, Poway, CA, USA) and the Encode SARS-CoV-2 split IgM/IgG One Step Rapid Test Device (Zhuhai Encode Medical Engineering, Zhuhai, China), were evaluated for performance against a laboratory immunoassay (EDI Novel Coronavirus COVID-19 IgG ELISA kit [Epitope Diagnostics, San Diego, CA, USA]) in 300 samples from health-care workers and 100 pre-COVID-19 negative control samples. In phase 2 (n=6440), serosurveillance was done among 1299 (93·4%) of 1391 health-care workers reporting symptoms, and in a subset of asymptomatic health-care workers (405 [8·0%] of 5049). FINDINGS: There was variation in test performance between the lateral flow serological assays; however, the Encode assay displayed reasonable IgG sensitivity (127 of 136; 93·4% [95% CI 87·8–96·9]) and specificity (99 of 100; 99·0% [94·6–100·0]) among PCR-proven cases and good agreement (282 of 300; 94·0% [91·3–96·7]) with the laboratory immunoassay. By contrast, the Onsite assay had reduced sensitivity (120 of 136; 88·2% [95% CI 81·6–93·1]) and specificity (94 of 100; 94·0% [87·4–97·8]) and agreement (254 of 300; 84·7% [80·6–88·7]). Five (7%) of 70 PCR-positive cases were negative across all assays. Late changes in lateral flow serological assay bands were recorded in 74 (9·3%) of 800 cassettes (35 [8·8%] of 400 Encode assays; 39 [9·8%] of 400 Onsite assays), but only seven (all Onsite assays) of these changes were concordant with the laboratory immunoassay. In phase 2, seroprevalence among the workforce was estimated to be 10·6% (95% CI 7·6–13·6) in asymptomatic health-care workers and 44·7% (42·0–47·4) in symptomatic health-care workers. Seroprevalence across the entire workforce was estimated at 18·0% (95% CI 17·0–18·9). INTERPRETATION: Although a good positive predictive value was observed with both lateral flow serological assays and ELISA, this agreement only occurred if the pre-test probability was modified by a strict clinical case definition. Late development of lateral flow serological assay bands would preclude postal strategies and potentially home testing. Identification of false-negative results among health-care workers across all assays suggest caution in interpretation of IgG results at this stage; for now, testing is perhaps best delivered in a clinical setting, supported by government advice about physical distancing. FUNDING: None.
has issue date	2020-07-24(xsd:dateTime)
bibo:doi	10.1016/s2213-2600(20)30315-5
bibo:pmid	32717210
has license	no-cc
sha1sum (hex)	33a3b6089774d5b2c1c26810b25d1af419af0532
schema:url	https://doi.org/10.1016/s2213-2600%2820%2930315-5
resource representing a document's title	Point-of-care serological assays for delayed SARS-CoV-2 case identification among health-care workers in the UK: a prospective multicentre cohort study
has PubMed Central identifier	PMC7380925
has PubMed identifier	32717210
schema:publication	Lancet Respir Med
resource representing a document's body	covid:33a3b6089774d5b2c1c26810b25d1af419af0532#body_text
is schema:about of	named entity 'testing' named entity 'severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)' named entity 'health-care' named entity 'substantial' named entity 'mild' named entity 'SARS-CoV-2' named entity 'SARS-CoV-2' named entity 'serology' named entity 'infection' named entity 'SARS-CoV-2' named entity 'health-care' named entity 'cohort study' named entity 'Point-of-care' named entity 'health-care' named entity 'serological' named entity 'serological' named entity 'health-care' named entity 'optical density' named entity 'SARS-CoV-2' named entity 'PCR' named entity 'England' named entity 'serological assay' named entity 'lateral flow' named entity 'inflammatory' named entity 'infection prevention and control' named entity 'PCR' named entity 'antibody response' named entity 'seroprevalence' named entity 'lateral flow' named entity 'health-care' named entity 'rapid diagnostic' named entity 'virus' named entity 'San Diego' named entity 'London' named entity 'infection' named entity 'PPE' named entity 'Phase 1' named entity 'Diagnostic Accuracy' named entity 'serological testing' named entity 'health-care' named entity 'SARS-CoV-2' named entity 'lateral flow' named entity 'IgM' named entity 'health-care' named entity 'health-care' named entity 'cross-reactivity' named entity 'optical density' named entity 'Case finding' named entity 'Essen' named entity 'lateral flow' named entity 'point-of-care' named entity 'asymptomatic' named entity 'Zhuhai' named entity 'serum samples' named entity 'significant difference' named entity 'PCR testing' named entity 'correlation' named entity 'health-care' named entity 'health-care' named entity 'Rapid Test' named entity 'health-care' named entity 'SARS-CoV-2' named entity 'health-care' named entity 'infection' named entity 'COVID' named entity 'serological assay' named entity 'general population'

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