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Performance Accuracy of a Laboratory-Developed Real-Time RT-PCR Method for Detection of SARS-CoV-2 in Self-Collected
D Jane Hata1, Edward L White2, Michaela M Bridgeman2
1Department of Laboratory Medicine and Pathology, Mayo Clinic, Jacksonville, FL, USA Hata.donna@mayo.edu.
Annals of Clinical and Laboratory Science
|December 18, 2021
Summary
Self-collected saliva is a viable option for detecting SARS-CoV-2 (COVID-19) using laboratory-developed PCR methods. This alternative sample type shows comparable results to nasopharyngeal swabs, aiding in expanded testing availability.
Area of Science:
- Medical Diagnostics
- Virology
- Molecular Biology
Background:
- The COVID-19 pandemic necessitates innovative diagnostic approaches.
- Traditional nasopharyngeal swabs present collection challenges.
- Evaluating alternative sample types like saliva is crucial for widespread testing.
Purpose of the Study:
- To assess the efficacy of saliva as a specimen for SARS-CoV-2 detection.
- To compare saliva-based molecular testing with established nasopharyngeal swab methods.
- To demonstrate the correlation between saliva and nasopharyngeal swab results.
Main Methods:
- A laboratory-developed real-time reverse transcription-polymerase chain reaction (LDPCR) assay was used.
- Saliva specimens were collected using a dedicated device.
- Results were compared against two FDA-approved emergency use authorization (EUA) methods using nasopharyngeal swabs.
Main Results:
- The LDPCR assay demonstrated a sensitivity of 75.0% and a specificity of 98.1% for saliva specimens.
- Cycle threshold values in saliva were slightly higher (mean difference of 4.66 cycles) compared to nasopharyngeal swabs for the open-reading frame gene.
Conclusions:
- Self-collected saliva is a reliable alternative sample type for SARS-CoV-2 detection.
- The LDPCR method using saliva correlates well with existing FDA EUA methods.
- Utilizing saliva can help expand SARS-CoV-2 testing capacity during the pandemic.
