Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Jun;9(11):921.
doi: 10.21037/atm-21-690.

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

Paul Hofman  1   2   3 , Jacques Boutros  4 , Didier Benchetrit  5 , Jonathan Benzaquen  3   4 , Sylvie Leroy  4   6 , Virginie Tanga  1   2 , Olivier Bordone  1   2 , Maryline Allégra  1   2 , Virginie Lespinet  1   2 , Julien Fayada  1   2 , Charlotte Maniel  4 , Jennifer Griffonnet  4 , Eric Selva  1   2 , Giancarlo Troncone  7 , Giuseppe Portella  7 , Thibaut Lavrut  8 , Richard Chemla  9 , Michel Carles  10 , Marius Ilié  1   2   3 , Charles Marquette  3   4
Affiliations

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

Paul Hofman et al. Ann Transl Med. 2021 Jun.

Abstract

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 Idylla™ 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 Idylla™ 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.

Keywords: Coronavirus 2019 disease (COVID-19); SARS-CoV-2; diagnosis; reverse transcriptase-polymerase chain reactions (RT-PCR).

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: On submission of the manuscript, all authors completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/atm-21-690). PH is a member of the scientific advisory board of Biocartis (Mechelen, Belgium). The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Self-reported symptoms (%).
Figure 2
Figure 2
CT values for the Orf1b and N genes measured with the standard of care (SOC) comparator and the Idylla test.
Figure 3
Figure 3
Relationship between CTs measured with the Idylla test (Y axis) and the SOC comparator (X axis) for the Orf1b and N genes.
Figure 4
Figure 4
Relationship between the CTs measured for the Orf1b (X axis) and N genes (Y axis) with the Idylla and standard of care tests.
See this image and copyright information in PMC

References

    1. Hanson KE, Caliendo AM, Arias CA, et al. Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19. Clin Infect Dis 2020. [Epub ahead of print]. doi: .10.1093/cid/ciaa760 - DOI - PMC - PubMed
    1. Lippi G, Adeli K, Ferrari M, et al. Biosafety measures for preventing infection from COVID-19 in clinical laboratories: IFCC Taskforce Recommendations. Clin Chem Lab Med 2020;58:1053-62. 10.1515/cclm-2020-0633 - DOI - PubMed
    1. Lechien JR, Chiesa-Estomba CM, Place S, et al. Clinical and epidemiological characteristics of 1420 European patients with mild-to-moderate coronavirus disease 2019. J Intern Med 2020;288:335-44. 10.1111/joim.13089 - DOI - PMC - PubMed
    1. Tanga V, Leroy S, Fayada J, et al. Establishment of a Collection of Blood-Derived Products from COVID-19 Patients for Translational Research: Experience of the LPCE Biobank (Nice, France). Biopreserv Biobank 2020;18:517-24. 10.1089/bio.2020.0055 - DOI - PubMed
    1. Li C, Zhao C, Bao J, et al. Laboratory diagnosis of coronavirus disease-2019 (COVID-19). Clin Chim Acta 2020;510:35-46. 10.1016/j.cca.2020.06.045 - DOI - PMC - PubMed