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Diagnostic Laboratory Tests for COVID-19 in US: Methodology and Performance.
Mrigendra M Bastola1, Craig Locatis1, Paul Fontelo1
1NIH/NLM/LHC.
Research Square
|August 4, 2020
Summary
Diagnostic tests for coronavirus disease 2019 (COVID-19) show variable accuracy. While many tests report high sensitivity and specificity, caution is advised due to potential false results and limited study scopes, especially with evolving evidence.
Area of Science:
- Infectious Diseases
- Diagnostic Accuracy
- Public Health
Background:
- The global COVID-19 pandemic necessitates reliable diagnostic testing.
- Concerns exist regarding the diagnostic performance of available COVID-19 tests, particularly during resurgences.
- Limited studies have comprehensively evaluated the diagnostic value of current tests.
Approach:
- Systematic review of published literature and FDA data on COVID-19 diagnostic tests.
- Calculation of likelihood ratios and predictive values for test performance assessment.
- Inclusion of only FDA-approved tests and exploration of RT-PCR performance across specimen types.
Key Points:
- RT-PCR is frequently used as a validation tool in COVID-19 test studies.
- Sensitivity and specificity data are not consistently reported across all available tests.
- Reported positive likelihood ratios varied (0.15-0.88), while negative likelihood ratios were high (0.99).
Conclusions:
- Despite some reports of high accuracy, limitations in study methodology and sample size impact the validity of COVID-19 test evaluations.
- Notable false omission and false discovery rates were observed in several laboratory tests.
- Careful interpretation of test results and integration of rapidly evolving evidence are crucial for practitioners.
