Impact of Pooling Samples on Analytic Sensitivity of a Real-Time Reverse Transcriptase PCR Assay for SARS CoV-2

Authors

Subathra MarimuthuFollow
Stephen P. Furmanek, University of LouisvilleFollow
Holly Aliesky, University of LouisvilleFollow
Leslie A. Wolf, University of LouisvilleFollow

Funder

The author(s) received no specific funding for this work

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.

DOI

10.18297/jri/vol6/iss1/1

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 License.

Recommended Citation

Marimuthu, Subathra; Furmanek, Stephen P.; Aliesky, Holly; and Wolf, Leslie A. (2022) "Impact of Pooling Samples on Analytic Sensitivity of a Real-Time Reverse Transcriptase PCR Assay for SARS CoV-2," The University of Louisville Journal of Respiratory Infections: Vol. 6 : Iss. 1 , Article 1.
DOI: https://doi.org/10.18297/jri/vol6/iss1/1
Available at: https://ir.library.louisville.edu/jri/vol6/iss1/1