tetano
Editor, Senior Moderator
Appl Lab Med
. 2021 Jun 22;jfab073.
doi: 10.1093/jalm/jfab073. Online ahead of print.
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 Daum[SUP] 1 [/SUP], Gerald W Fischer[SUP] 1 [/SUP]
Affiliations
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.
Keywords: COVID-19; Liat; Longhorn; PrimeStore MTM; Roche; SARS-CoV-2; diagnostics; molecular transport medium; qPCR.
. 2021 Jun 22;jfab073.
doi: 10.1093/jalm/jfab073. Online ahead of print.
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 Daum[SUP] 1 [/SUP], Gerald W Fischer[SUP] 1 [/SUP]
Affiliations
- PMID: 34156459
- DOI: 10.1093/jalm/jfab073
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.
Keywords: COVID-19; Liat; Longhorn; PrimeStore MTM; Roche; SARS-CoV-2; diagnostics; molecular transport medium; qPCR.