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Comparison of 6 SARS-CoV-2 Molecular Methods and Correlation With the Cycle Threshold Distribution in Clinical Specimens.
Raju, Saravanan; Anderson, Neil W; Robinson, Elizabeth; Squires, Crystal; Wallace, Meghan A; Zhang, Ray; Burnham, Carey-Ann D; Parikh, Bijal A.
  • Raju S; Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  • Anderson NW; Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  • Robinson E; Department of Laboratories, Barnes-Jewish Hospital, St. Louis, MO, USA.
  • Squires C; Department of Laboratories, Barnes-Jewish Hospital, St. Louis, MO, USA.
  • Wallace MA; Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  • Zhang R; Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  • Burnham CD; Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA.
  • Parikh BA; Department of Molecular Microbiology, Washington University School of Medicine, St. Louis, MO, USA.
J Appl Lab Med ; 6(6): 1452-1462, 2021 Nov 01.
Article in English | MEDLINE | ID: covidwho-1493847
ABSTRACT

BACKGROUND:

The detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patient samples is of critical importance in the management of patients and monitoring transmission in the population. However, data on the analytical performance characteristics for detection of SARS-CoV-2 in clinical specimens between individual targets within the same platform, and among different analytical platforms, are limited.

METHODS:

Here we evaluated the performance of 6 different sample-to-answer SARS-CoV-2 detection methods-Roche cobas 6800, Cepheid GeneXpert, Diasorin Simplexa, Luminex Aries emergency use authorization (EUA), Luminex Aries research use only (RUO), and bioMérieux BioFire-in clinical specimens with a range of viral loads.

RESULTS:

The positive percentage agreement between the Roche cobas 6800 and GeneXpert was 100%, Diasorin 95%, Aries EUA 74%, Aries RUO 83%, and BioFire 97%. Notably, in samples with cycle threshold (Ct) values below 30 for the E gene on the Roche cobas 6800 platform, we found 100% positive agreement among all platforms. Given these results, we examined the distribution of over 10 000 Ct values of all positive specimens from individuals at our institution on the Roche cobas platform. Nearly 60% of specimens from asymptomatic individuals had a PCR Ct value >30 as measured using the cobas 6800 assay E gene.

CONCLUSIONS:

Our results demonstrate performance characteristics between different platforms by Ct value and provide data regarding the distribution of viral RNA present in positive specimens.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: J Appl Lab Med Year: 2021 Document Type: Article Affiliation country: Jalm

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: J Appl Lab Med Year: 2021 Document Type: Article Affiliation country: Jalm