Abstract
During the COVID-19 pandemic, laboratories experienced periods of shortages for certain critical materials required to meet the high demand for SARS-CoV-2 testing. The U.S. Food & Drug Administration provided a template for molecular diagnostic testing, including guidance for a specimen pooling process in order to evaluate performance of the SARS-CoV-2 nucleic acid amplification assay. This study aimed to evaluate the testing of pooled specimens consisting of four nasopharyngeal swab specimens using the Luminex ARIES® nucleic acid amplification platform. Results indicated that there was a loss of analytic sensitivity with pooled nasopharyngeal swab samples, demonstrating that this approach should be balanced against material shortages and the clinical utility of a less sensitive assay.
Highlights
When the World Health Organization (WHO) declared COVID-19 a pandemic in March 2020 [1], the demand for laboratory testing increased dramatically
The University of Louisville (UofL) Infectious Diseases Laboratory validated a TaqMan real-time reverse transcriptionpolymerase chain reaction (RT-PCR) assay for SARS-CoV-2 with nasopharyngeal swabs (NP) specimens tested individually
The limit of detection (LOD) was the cycle threshold (Ct) value at which 100% of the individually tested NP specimens were positive in triplicate, and this final LOD concentration was confirmed by testing 24 individual replicates
Summary
When the World Health Organization (WHO) declared COVID-19 a pandemic in March 2020 [1], the demand for laboratory testing increased dramatically This high demand for testing placed considerable pressure on healthcare providers and especially clinical laboratories to collect, process, and test the recommended respiratory samples, with nasopharyngeal swabs (NP) being the “gold standard.”. Device manufacturers needed to rapidly deploy viral transport media, instruments, kits, and reagents to their customers under the U.S Food & Drug Administration (FDA) emergency use authorization (EUA) guidelines. Due to these factors, competition for limited supplies led to periodic shortages of real-time reverse transcriptionpolymerase chain reaction (RT-PCR) materials for clinical laboratories. True savings of materials, time, and labor costs would be realized
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