New rapid point-of-care SARS-CoV-2 test validated

  • Amran M & al
  • Lancet Microbe
  • 18/09/2020

  • Liz Scherer
  • Clinical Essentials
L'accesso ai contenuti di questo sito è riservato agli operatori del settore sanitario italiano L'accesso ai contenuti di questo sito è riservato agli operatori del settore sanitario italiano

Takeaway

  • A new, laboratory-free, rapid (
  • The test removes the need for laboratory infrastructure, has been in use in the UK since May 2020, and is being rolled out nationally.

Why this matters

  • Rapid point-of-care testing may expand testing capacity and alleviate pressure on clinical practices, especially as the Northern hemisphere enters the winter season and the likelihood is increased for influenza/COVID-19 overlap.

Key results

  • 386 paired samples, derived from among health care workers (73%; n=280), emergency department (ED) patients (4%; n=15), and hospital inpatients (23%; n=91).
  • Valid samples: overall prevalence of laboratory-positive tests, 18% (71/286); highest prevalence seen in ED patients (33%; 95% CI, 12%-62%).
  • Greater numbers of laboratory-positive tests obtained in April 2020 (25%; 95% CI, 20%-31%) vs May 2020 (3%; 95% CI, 1%-7%).
  • Overall sensitivity vs laboratory testing: 94% (95% CI, 86%-98%); specificity: 100% (95% CI, 99%-100%).
  • Specificity was consistent among groups.

Study design

  • Multicenter clinical validation performance study of CovidNudge, a rapid point-of-care RT-PCR test for SARS-CoV-2, in the UK over 6 weeks.
  • Funding: National Institute for Health Research; others.

Limitations

  • Cross-platform comparison vs single platform, local standards of care.
  • Relatively small cohort.
  • Low throughput; may require multiple processing units.