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Large-Scale SARS-CoV-2 Testing Utilizing Saliva and Transposition Sample Pooling

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Identification of SARS-CoV-2 in a Proficiency Testing Program.

Daniel C Edson¹, Danielle L Casey¹, Susan E Harmer¹

¹American Proficiency Institute, Traverse City, MI.

American Journal of Clinical Pathology

|July 21, 2020

Summary

This summary is machine-generated.

Newly developed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular tests demonstrated excellent accuracy in a large-scale proficiency challenge. These reliable SARS-CoV-2 RNA detection assays provide confidence for clinical and public health decisions.

Keywords:

CLIA ‘88 Coronavirus Microbiology Molecular diagnostics Proficiency testing Quality SARS-CoV-2

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Area of Science:

Clinical diagnostics
Molecular biology
Virology

Background:

The initial phase of the SARS-CoV-2 pandemic saw limited testing capacity, primarily relying on the CDC's RT-PCR assay.
High demand for SARS-CoV-2 testing spurred rapid development of new diagnostic assays.

Purpose of the Study:

To evaluate the accuracy of newly developed SARS-CoV-2 detection assays.
To assess the performance of molecular tests used for diagnosing SARS-CoV-2 infections.

Main Methods:

The American Proficiency Institute distributed two test samples (one positive, one negative) to 346 clinical laboratories.
Samples contained quantified viral loads or recombinant virus particles for accurate assessment.

Main Results:

Nearly all laboratories correctly identified the presence (97.4%) and absence (98.3%) of SARS-CoV-2.
A small percentage of errors (1.6%) were attributed to clerical mistakes rather than assay performance.

Conclusions:

The performance of SARS-CoV-2 RNA detection assays in this challenge was excellent.
These findings support the reliability of new molecular tests for clinical and public health applications.