دورية أكاديمية
Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population.
العنوان: | Point-of-care SARS-CoV-2 serological assays for enhanced case finding in a UK inpatient population. |
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المؤلفون: | Pallett SJC; Centre of Defence Pathology, Royal Centre for Defence Medicine, Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, UK.; Clinical Infection Department, Chelsea and Westminster NHS Foundation Trust, 369 Fulham Road, London, SW10 9NH, UK., Denny SJ; Clinical Infection Department, Chelsea and Westminster NHS Foundation Trust, 369 Fulham Road, London, SW10 9NH, UK.; North West London Pathology, Fulham Palace Road, London, W6 8RF, UK., Patel A; Clinical Infection Department, Chelsea and Westminster NHS Foundation Trust, 369 Fulham Road, London, SW10 9NH, UK., Charani E; NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, Imperial College London, Hammersmith Campus, Du Cane Road, London, W12 0NN, UK., Mughal N; Clinical Infection Department, Chelsea and Westminster NHS Foundation Trust, 369 Fulham Road, London, SW10 9NH, UK.; North West London Pathology, Fulham Palace Road, London, W6 8RF, UK.; NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, Imperial College London, Hammersmith Campus, Du Cane Road, London, W12 0NN, UK., Stebbing J; Department of Surgery and Cancer, Imperial College London, Hammersmith Campus, Du Cane Road, London, W12 0NN, UK., Davies GW; Clinical Infection Department, Chelsea and Westminster NHS Foundation Trust, 369 Fulham Road, London, SW10 9NH, UK., Moore LSP; Clinical Infection Department, Chelsea and Westminster NHS Foundation Trust, 369 Fulham Road, London, SW10 9NH, UK. l.moore@imperial.ac.uk.; North West London Pathology, Fulham Palace Road, London, W6 8RF, UK. l.moore@imperial.ac.uk.; NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, Imperial College London, Hammersmith Campus, Du Cane Road, London, W12 0NN, UK. l.moore@imperial.ac.uk. |
المصدر: | Scientific reports [Sci Rep] 2021 Mar 12; Vol. 11 (1), pp. 5860. Date of Electronic Publication: 2021 Mar 12. |
نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
اللغة: | English |
بيانات الدورية: | Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE |
أسماء مطبوعة: | Original Publication: London : Nature Publishing Group, copyright 2011- |
مواضيع طبية MeSH: | COVID-19 Testing*/methods , Inpatients* , Point-of-Care Testing* , SARS-CoV-2*/genetics , SARS-CoV-2*/immunology , Serologic Tests*, COVID-19/*diagnosis , COVID-19/*virology, Aged ; Aged, 80 and over ; Antibodies, Viral/immunology ; COVID-19/epidemiology ; Female ; Humans ; Immunoglobulin G/immunology ; Immunoglobulin M/immunology ; Male ; Middle Aged ; Public Health Surveillance ; Real-Time Polymerase Chain Reaction ; Reproducibility of Results ; United Kingdom/epidemiology |
مستخلص: | Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Case identification is currently made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but independent validation is urgently required to assess their utility. We evaluated five different point-of-care (POC) SARS-CoV-2 antibody test kits against PCR, finding concordance across the assays (n = 15). We subsequently tested 200 patients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette and find a sensitivity of 74% in the early infection period (day 5-9 post symptom onset), with 100% sensitivity not seen until day 13, demonstrating inferiority to PCR testing in the infectious period. Negative rate was 96%, but in validating the serological tests uncovered potential false-negatives from PCR testing late-presenting cases. A positive predictive value (PPV) of 37% in the general population precludes any use for general screening. Where a case definition is applied however, the PPV is substantially improved (95.4%), supporting use of serology testing in carefully targeted, high-risk populations. Larger studies in specific patient cohorts, including those with mild infection are urgently required to inform on the applicability of POC serological assays to help control the spread of SARS-CoV-2 and improve case finding of patients that may experience late complications. |
References: | Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. (PMID: 32221519) Euro Surveill. 2015 Mar 26;20(12):. (PMID: 25846490) Lancet Infect Dis. 2020 Jul;20(7):773. (PMID: 32171390) Sichuan Da Xue Xue Bao Yi Xue Ban. 2020 Mar;51(2):131-138. (PMID: 32220177) Nature. 2020 May;581(7809):465-469. (PMID: 32235945) Lancet Infect Dis. 2021 Jan 20;:. (PMID: 33484647) Lancet. 2020 Feb 22;395(10224):542-545. (PMID: 32061313) Lancet Respir Med. 2020 Sep;8(9):885-894. (PMID: 32717210) Int J Infect Dis. 2020 May;94:91-95. (PMID: 32173574) Emerg Infect Dis. 2020 Jul;26(7):1478-1488. (PMID: 32267220) |
المشرفين على المادة: | 0 (Antibodies, Viral) 0 (Immunoglobulin G) 0 (Immunoglobulin M) |
تواريخ الأحداث: | Date Created: 20210313 Date Completed: 20210329 Latest Revision: 20210329 |
رمز التحديث: | 20221213 |
مُعرف محوري في PubMed: | PMC7955061 |
DOI: | 10.1038/s41598-021-85247-w |
PMID: | 33712679 |
قاعدة البيانات: | MEDLINE |
تدمد: | 2045-2322 |
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DOI: | 10.1038/s41598-021-85247-w |