Analytic Sensitivity of 3 Nucleic Acid Detection Assays in Diagnosis of SARS-CoV-2 Infection
| Autor: | Coteia Pina, Gary L Horowitz, Ming Zhou, Arthur R. Rabson, Coby Horowitz, Cheng-Tsung K Hu, Meriane Lacombe-Daphnis, Bernadette Chirokas, Steven A. Bogen, Jakob T. Sieker, Nicholas E. Heger |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Oropharyngeal swab Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Real-Time Polymerase Chain Reaction Article Virus 03 medical and health sciences 0302 clinical medicine Limit of Detection Humans Medicine 030212 general & internal medicine False Negative Reactions Aged Retrospective Studies Aged 80 and over GeneXpert MTB/RIF SARS-CoV-2 business.industry COVID-19 Reproducibility of Results General Medicine Middle Aged Virology Reverse transcription polymerase chain reaction COVID-19 Nucleic Acid Testing 030220 oncology & carcinogenesis RNA Viral Female Reagent Kits Diagnostic business Nucleic acid detection |
| Zdroj: | The Journal of Applied Laboratory Medicine |
| ISSN: | 2475-7241 2576-9456 |
| DOI: | 10.1093/jalm/jfaa187 |
| Popis: | Background Detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription PCR is the primary method to diagnose coronavirus disease 2019 (COVID-19). However, the analytic sensitivity required is not well defined and it is unclear how available assays compare. Methods For the Abbott RealTime SARS-CoV-2 assay (m2000; Abbott Molecular), we determined that it could detect viral concentrations as low as 26 copies/mL, we defined the relationship between cycle number and viral concentrations, and we tested naso- and oropharyngeal swab specimens from 8538 consecutive individuals. Using the m2000 as a reference assay method, we described the distribution of viral concentrations in these patients. We then used selected clinical specimens to determine the positive percent agreement of 2 other assays with more rapid turnaround times [Cepheid Xpert Xpress (GeneXpert; Cepheid); n = 27] and a laboratory developed test on the Luminex ARIES system [ARIES LDT (Luminex); n = 50] as a function of virus concentrations, from which we projected their false-negative rates in our patient population. Results SARS-CoV-2 was detected in 27% (95% CI: 26%–28%) of all specimens. Estimated viral concentrations were widely distributed, and 17% (95% CI: 16%–19%) of positive individuals had viral concentrations 100 copies/mL for the GeneXpert but not the ARIES LDT, corresponding to projected false-negative rates of 4% (95% CI: 0%–21%) and 27% (95% CI: 11%–46%), respectively. Conclusions Substantial proportions of clinical specimens have low to moderate viral concentrations and may be missed by methods with less analytic sensitivity. |
| Databáze: | OpenAIRE |
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