Abstract
Background: The ability to rapidly detect severe accurate respiratory syndrome coronavirus virus-2 (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 the Food and Drug’s Emergency Use Authorization 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 preprocessing 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 quantitative PCR (qPCR). Additionally, a clinical panel of NP and oral swabs collected in PS-MTM during the 2020 coronavirus disease 2019 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, noninfectious sample processing for near-patient testing.
Keywords: COVID-19; Liat; Longhorn; PrimeStore MTM; Roche; SARS-CoV-2; diagnostics; molecular transport medium; qPCR.
【저자키워드】 COVID-19, SARS-CoV-2, diagnostics, qPCR, Liat, Roche, Longhorn, PrimeStore MTM, molecular transport medium, 【초록키워드】 coronavirus disease, Coronavirus disease 2019, coronavirus, pandemic, Clinical symptoms, Influenza, Infection, Test, media, Influenza virus, drug, virus, nasopharyngeal, qPCR, nucleic acid test, limit of detection, gold, SARS-CoV-2 RNA, Swab, disease detection, virus infection, molecular, nasal swab, respiratory, Roche, Critical, quantitative PCR, food, Emergency, Safe, transport medium, specimen collection, Transport, Patient care, overlap, medium, gold standard, specimen, approval, respiratory syndrome coronavirus, acid, authorization, positive, nasal swabs, oral swab, oral swabs, ambient, benefit, detect, collected, evaluated, exhibited, added, UTM, 【제목키워드】 detection, RNA, Testing, PCR, clinical, Rapid,