Molecular Mirror Technology Facilitates High-Throughput, Accurate SARS-CoV-2 Testing

Autor: Suresh M. Menon, Jovan Shepherd, David A. Lipson, Sara Hash, Frederick Fung, Roland B. Liu, Robert T. Schooley, David T. Pride, Charlene Wong, Susan Realegeno
Rok vydání: 2021
Předmět:
Male
Emergency Use Authorization
Technology
Physiology
Gastroenterology
Polymerase Chain Reaction
Child
Aged
80 and over
education.field_of_study
Ecology
Middle Aged
QR1-502
nucleic acid amplification
Reverse transcription polymerase chain reaction
Infectious Diseases
Molecular Diagnostic Techniques
COVID-19 Nucleic Acid Testing
Child
Preschool
Female
Research Article
Microbiology (medical)
Adult
medicine.medical_specialty
Coronavirus disease 2019 (COVID-19)
Adolescent
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Population
Microbiology
Sensitivity and Specificity
Young Adult
Internal medicine
Molecular Mirror
High-Throughput Screening Assays
Genetics
medicine
Humans
education
Pandemics
Aged
automation
General Immunology and Microbiology
business.industry
SARS-CoV-2
COVID-19
Infant
Cell Biology
Confidence interval
nuclear magnetic resonance
Nucleic acid
business
Zdroj: Microbiology Spectrum
Microbiology Spectrum, Vol 9, Iss 1 (2021)
ISSN: 2165-0497
Popis: Tests to diagnose acute SARS-CoV-2 infection are at the center of controlling the COVID-19 pandemic. Rapid tests benefit from providing quick results but suffer from lower sensitivity, while PCR tests usually take longer to provide more reliable results and can be difficult to scale to meet population needs. We evaluated the diagnostic efficacy of a Molecular Mirror assay (MMA) using nucleic acid extraction and a nucleic acid extraction-free method to determine its ability to identify SARS-CoV-2 in nasal specimens from individuals suspected of having SARS-CoV-2. We compared the MMA using nucleic acid extraction to the emergency use authorization (EUA)-approved TaqPath reverse transcriptase PCR (RT-PCR) assay to determine its performance characteristics. From 412 total specimens (including 115 previous positives and 297 previous negatives), we found that the positive percent agreement (PPA) was 99.1% (confidence interval [CI], 97.4% to 100.0%) and the negative percent agreement (NPA) was 99.3% (95% CI, 98.4% to 100.0%) for SARS-CoV-2 detection. Using the extraction-free method, we analyzed 109 specimens (51 previous positives and 58 previous negatives) and found that the PPA for the more rapid version of the assay was 87.8% (95% CI, 78.5% to 96.9%) and the NPA was 100.0% (95% CI, 100.0%) for virus detection. The extraction method has performance comparable to what is observed in many PCR-based assays. The extraction-free method has lower PPA but has the advantage of being more rapid and having a higher throughput. Our data offer a proof of concept that nuclear magnetic resonance (NMR) detection can be used in SARS-CoV-2 diagnostic testing and may allow for alternative supply chains to increase testing options. IMPORTANCE Accurate diagnostics for SARS-CoV-2 infections have been critical for responding to the COVID-19 pandemic. Both high-sensitivity/specificity PCR-based tests and lower-sensitivity/specificity rapid antigen assays have been the subject of worldwide supply chain limitations as individual facilities and countries have struggled to meet their population testing needs. We evaluated the diagnostic efficacy of a Molecular Mirror assay (MMA), which uses nuclear magnetic resonance to detect the presence of SARS-CoV-2 nucleic acids both with and without full nucleic acid extractions. We found that compared to a U.S. emergency use authorization (EUA) approved assay (TaqPath) that uses reverse transcriptase PCR (RT-PCR), the MMA had high PPA and NPA with full nucleic acid extractions, and acceptable positive percent agreement (PPA) and negative percent agreement (NPA) with an extraction-free protocol. In a landscape marred by supply chain shortages across the world, altered SARS-CoV-2 detection methods such as the MMA can add to testing supplies while providing quality SARS-CoV-2 testing results.
Databáze: OpenAIRE
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