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Clarifying the evidence on SARS-CoV-2 antigen rapid tests in public health responses to COVID-19

The Lancet (British edition), 2021-04, Vol.397 (10283), p.1425-1427 [Peer Reviewed Journal]

2021 Elsevier Ltd ;2021. Elsevier Ltd ;2021 Elsevier Ltd. All rights reserved. 2021 Elsevier Ltd ;ISSN: 0140-6736 ;EISSN: 1474-547X ;DOI: 10.1016/S0140-6736(21)00425-6 ;PMID: 33609444

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  • Title:
    Clarifying the evidence on SARS-CoV-2 antigen rapid tests in public health responses to COVID-19
  • Author: Mina, Michael J ; Peto, Tim E ; García-Fiñana, Marta ; Semple, Malcolm G ; Buchan, Iain E
  • Subjects: Antigens ; Asymptomatic ; Comment ; Coronaviruses ; COVID-19 ; COVID-19 - diagnosis ; COVID-19 diagnostic tests ; COVID-19 Nucleic Acid Testing ; COVID-19 Serological Testing ; Deduction ; Disease transmission ; Epidemics ; Humans ; Immune system ; Infections ; Infectious diseases ; Laboratories ; Medical personnel ; Medical research ; Outbreaks ; Pilots ; Public health ; Public Health Administration ; Ribonucleic acid ; RNA ; SARS-CoV-2 ; Secretions ; Sensitivity ; Sensitivity and Specificity ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Signs and symptoms ; Stalling ; United Kingdom ; Viral diseases ; Viruses
  • Is Part Of: The Lancet (British edition), 2021-04, Vol.397 (10283), p.1425-1427
  • Description: The debate surrounding the use of the Innova Lateral Flow SARS-CoV-2 Antigen Test in the UK risks confusing policy makers internationally and potentially stalling deployment of LFTs in other countries.5 As scientists and health professionals evaluating some of the world's largest pilots of LFT, we wish to challenge those interpretations and clarify the evidence on how such testing might be used to detect SARS-CoV-2 in minutes and improve COVID-19 control measures. Most people infected with SARS-CoV-2 are contagious for 4–8 days.7 Specimens are generally not found to contain culture-positive (potentially contagious) virus beyond day 9 after the onset of symptoms, with most transmission occurring before day 5.7,8 This timing fits with the observed patterns of virus transmission (usually 2 days before to 5 days after symptom onset), which led public health agencies to recommend a 10-day isolation period.9 The short window of transmissibility contrasts with a median 22–33 days of PCR positivity (longer with severe infections and somewhat shorter among asymptomatic individuals).10 This suggests that 50–75% of the time an individual is PCR positive, they are likely to be post-infectious.11,12 Once SARS-CoV-2 replication has been controlled by the immune system, RNA levels detectable by PCR on respiratory secretions fall to very low levels when individuals are much less likely to infect others.13–15 The remaining RNA copies can take weeks, or occasionally months,16,17 to clear, during which time PCR remains positive.7 A public health test for detecting someone who might be contagious is, by logical deduction, expected to have a sensitivity of around 30–40% versus PCR when testing a random sample of asymptomatic people in a steady-state outbreak.18 Furthermore, the asymmetry of RNA reflecting more infectiousness nearer to the time of exposure, means that the sensitivity of the ideal test of infectiousness when measured against PCR may vary across the epidemic curve, from as high as 50–60% when an outbreak is surging to 20–30% or less as infections decline.19 LFT and the UK testing programme have been criticised1–3,5 for poor sensitivity in people without symptoms. MGS is Chair of the Infectious Disease Scientific Advisory Board and a minority shareholder in Integrum Scientific LLC, Greensboro, NC, USA, a company that has interests in COVID-19 testing but not with lateral flow technology, and reports grants from the NIHR, the Medical Research Council, and the Health Protection Research Unit in Emerging and Zoonotic Infections, University of Liverpool.
  • Publisher: England: Elsevier Ltd
  • Language: English
  • Identifier: ISSN: 0140-6736
    EISSN: 1474-547X
    DOI: 10.1016/S0140-6736(21)00425-6
    PMID: 33609444
  • Source: ProQuest One Psychology
    MEDLINE
    ProQuest Central

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