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SARS-CoV-2 emergency use authorization published sensitivity differences do not correlate with positivity rate in a
Joseph H Blommel1, Luigi Boccuto2, Diana S Ivankovic2
1Department of Laboratory Medicine and Pathology, Mayo Clinic, 200 1st Street Southwest, Rochester, MN 55905, United States.
Diagnostic Microbiology and Infectious Disease
|December 15, 2023
Summary
During the COVID-19 pandemic, multiple SARS-CoV-2 testing platforms were used. Differences in test sensitivity did not significantly impact positivity rates or discordant results, emphasizing capacity needs.
Area of Science:
- Virology
- Clinical Diagnostics
- Public Health
Background:
- The COVID-19 pandemic led to high demand for SARS-CoV-2 testing.
- Supply chain disruptions necessitated the use of diverse molecular testing platforms.
Approach:
- Reviewed results from approximately 2.9 million SARS-CoV-2 tests.
- Analyzed data from 8 ordered services and 9 emergency use authorized (EUA) tests.
- Examined 10 possible ordered service/EUA combinations.
Key Points:
- Variability in positivity rates was observed across different SARS-CoV-2 testing platforms.
- No significant correlation was found between the reported limit of detection and positivity rates.
- Differences in test sensitivity did not correlate with observed discordant results.
Conclusions:
- The choice of SARS-CoV-2 molecular testing platforms did not significantly alter positivity rates.
- Balancing testing capacity with test sensitivity is crucial for public health response.
- Clinical laboratories must consider practical limitations when selecting diagnostic tests.
