Literature DB >> 34156459

Rapid and Safe Detection of SARS-CoV-2 and Influenza Virus RNA using Onsite qPCR Diagnostic Testing from Clinical Specimens Collected in Molecular Transport Medium.

Luke T Daum1, Gerald W Fischer1.   

Abstract

BACKGROUND: The ability to rapidly detect SARS-CoV-2 and influenza virus infection is vital for patient care due to overlap in clinical symptoms. Roche's cobas® Liat® SARS-CoV-2 & Influenza A/B Nucleic Acid Test used on the cobas® Liat® was granted approval under FDA's Emergency Use Authorization (EUA) for nasopharyngeal (NP) and nasal swabs collected in viral/universal transport medium (VTM/UTM). However, there is a critical need for media that inactivates the virus, especially when specimens are collected in decentralized settings. This study aimed to investigate the use of PrimeStore Molecular Transport Medium® (PS-MTM®), designed to inactivate/kill and stabilize RNA/DNA for ambient transport and pre-processing of collected samples.
METHODS: A limit of detection (LOD) using serially diluted SARS-CoV-2 RNA in PS-MTM® and routine UTM was established using standard qPCR. Additionally, a clinical panel of NP and oral swabs collected in PS-MTM® collected during the 2020 coronavirus disease 2019 (COVID-19) pandemic were evaluated on the cobas® Liat® and compared to 'gold standard' qPCR on an ABI-7500 instrument.
RESULTS: SARS-CoV-2 RNA LOD using standard qPCR was equivalent on the cobas® Liat® instrument. cobas® Liat® detection from oral/NP swabs in PS-MTM® media exhibited equivalent positive percent agreement (100%) and negative percent agreement (96.4%).
CONCLUSION: PS-MTM® and the Roche cobas® Liat® are compatible and complimentary devices for respiratory specimen collection and rapid disease detection, respectively. PS-MTM® is equivalent to standard VTM/UTM with the added benefit of safe, non-infectious sample processing for near-patient testing.
© 2021 American Association for Clinical Chemistry.

Entities:  

Keywords:  COVID-19; Liat; Longhorn; PrimeStore MTM; Roche; SARS-CoV-2; diagnostics; molecular transport medium; qPCR

Year:  2021        PMID: 34156459     DOI: 10.1093/jalm/jfab073

Source DB:  PubMed          Journal:  J Appl Lab Med        ISSN: 2475-7241


  2 in total

Review 1.  FDA authorized molecular point-of-care SARS-CoV-2 tests: A critical review on principles, systems and clinical performances.

Authors:  Brigitte Bruijns; Laura Folkertsma; Roald Tiggelaar
Journal:  Biosens Bioelectron X       Date:  2022-05-21

2.  SARS-CoV-2 screening in patients in need of urgent inpatient treatment in the Emergency Department (ED) by digitally integrated point-of-care PCR: a clinical cohort study.

Authors:  Martin Möckel; Myrto Bolanaki; Jörg Hofmann; Angela Stein; Jennifer Hitzek; Fabian Holert; Antje Fischer-Rosinský; Anna Slagman
Journal:  Diagn Microbiol Infect Dis       Date:  2022-01-16       Impact factor: 2.983

  2 in total

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