A rapid near-patient RT-PCR test for suspected COVID-19: a study of the diagnostic accuracy.

Hofman, Paul; Boutros, Jacques; Benchetrit, Didier; Benzaquen, Jonathan; Leroy, Sylvie; Tanga, Virginie; Bordone, Olivier; Allégra, Maryline; Lespinet, Virginie; Fayada, Julien; Maniel, Charlotte; Griffonnet, Jennifer; Selva, Eric; Troncone, Giancarlo; Portella, Giuseppe; Lavrut, Thibaut; Chemla, Richard; Carles, Michel; Ilié, Marius; Marquette, Charles

Background Management of large numbers of reverse transcriptase-polymerase chain reactions (RT-PCR) for diagnosis of coronavirus 2019 disease (COVID-19) requires robust infrastructures, located in dedicated premises with a high standard of biosafety procedures, and well-trained personnel. The handling of a "run-of-river sample" to obtain rapid reporting of results is challenging. Methods We studied the clinical performance of the Idyllaâ„¢ SARS-CoV-2 Test (index test) on a platform capable of fully automated nucleic acid testing including extraction, amplification, and detection in a single-use cartridge to establish the diagnosis of COVID-19. The study was conducted on a prospective cohort of 112 volunteers with recent symptoms and an unknown SARS-CoV-2 status who came to free screening centers of the Nice metropolitan area. All subjects underwent bilateral nasopharyngeal sampling. One sample was processed using the index test, the other using the standard of care RT-PCR. Samples were treated blind. Results Most of the participants (70%) were sampled within 4 days of symptom onset. Forty-five (40.2%) were positive for COVID-19. No clinical symptoms were distinguished between SARS-CoV-2 RT-PCR positive and negative subjects except anosmia and dysgeusia. Positive and negative agreement between the index and the standard of care test was 100%. Conclusions The Idyllaâ„¢ SARS-CoV-2 Test is very sensitive, specific, rapid and easy to use in a near-patient RT-PCR approach to distinguish between symptomatic SARS-CoV-2 positive and negative patients in selected settings.