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COVID-19 Management

2022 Cochrane Update: How Reliable are COVID-19 Rapid Tests?

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BACKGROUND AND PURPOSE:

  • Dinnes et al. (Cochrane Database of Systematic Reviews, 2022) update a 2021 review and meta-analysis investigating the diagnostic accuracy of rapid, point-of-care SARS-CoV-2 antigen tests

METHODS:

  • Systematic review and meta-analysis
  • Inclusion criteria
    • Studies of people with either suspected SARS-CoV-2 infection, known infection or known absence of infection
    • Test accuracy studies of any design that evaluated commercially produced, rapid antigen tests
    • Evaluations of single applications of a test (one test result reported per person) and evaluations of serial testing (repeated antigen testing over time)
  • Study design
    • Controls for infection status were any laboratory-based molecular test (primarily RT-PCR) or pre-pandemic respiratory sample
    • Data pooling and quality assessment were performed
    • Random-effects logistic regression models were used
  • Primary outcome
    • Sensitivity and specificity of each test

RESULTS:

  • 155 cohort studies | 100,462 unique samples in main results
    • Commercial antigen assays evaluated: 49
    • Risk of bias in included studies was high

Rapid Test Sensitivity and Specificity

  • Test sensitivity was higher in symptomatic vs asymptomatic individuals
    • Symptomatic
      • Mean sensitivity: 73.0% (95% CI, 69.3 to 76.4)
      • 109 evaluations | 50,574 samples | 11,662 cases
    • Asymptomatic
      • Mean sensitivity: 54.7% (95% CI, 47.7 to 61.6)
      • 50 evaluations | 40,956 samples | 2641 cases
  • Test sensitivity was also higher in the first week after symptom onset
    • First week after symptom onset
      • Mean sensitivity: 80.9% (95% CI, 76.9 to 84.4)
      • 30 evaluations | 2408 cases
    • Second week after symptom onset
      • Mean sensitivity: 53.8% (95% CI, 48.0 to 59.6)
      • 40 evaluations | 1119 cases
  • For those who were asymptomatic at the time of testing, sensitivity was higher when exposure to SARS-CoV-2 was suspected
    • Suspected exposure
      • Mean sensitivity: 64.3% (95% CI, 54.6 to 73.0)
      • 16 evaluations | 7677 samples | 703 cases
    • Widely available COVID-19 testing for anyone
      • Mean sensitivity: 49.6% (95% CI, 42.1 to 57.1)
      • 26 evaluations | 31,904 samples | 1758 cases
  • Mean test specificity was similarly high for both symptomatic and asymptomatic participants
    • Symptomatic: 99.1%
    • Asymptomatic: 99.7%
  • There was a decline in sensitivities as sample viral load decreased

Sensitivity Varies Widely Between Test Brands

  • For symptomatic participants
    • Number of assays with sensitivity meeting WHO performance criterion of ≥80%: 7 assays
    • Number of assays with specificity meeting WHO performance criterion of ≥97%: 17 assays | 12 of demonstrated specificities >99%
  • Performance range among symptomatic individuals
    • Mean sensitivity 34.3% to 91.3%
  • Performance range among asymptomatic individuals
    • Mean sensitivity 28.6% to 77.8%

Modeled Positive Predictive Value of Rapid Tests

  • At 5% prevalence: Using summary data in symptomatic people during the first week after symptom onset, the positive predictive value (PPV) of rapid testing was 89%
    • Predicted false positives: 1 in 10 positive tests
    • Predicted missed cases: 1 in 5 cases
  • At 0.5% prevalence: Using summary data for asymptomatic people where exposure was suspected, PPV was between 38 and 52%
    • Predicted false positives: between 2 in 5 and 1 in 2 positive tests
    • Predicted missed cases: between 1 in 2 and 1 in 3 cases

CONCLUSION:

  • Estimates of test sensitivity varied considerably between studies and test brand, but specificity was consistently high for most brands
  • Test sensitivity was highest when viral loads likely to be elevated
    • In the first week of illness
    • Among symptomatic individuals
    • Among asymptomatic individuals who suspected COVID-19 exposure
  • Some tests, like those that met WHO test standards, were specific and sensitive enough to replace RT-PCR among symptomatic individuals, while others would be more suited to determining which individuals should receive follow-up RT-PCR testing

Learn More – Primary Sources:

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

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Related ObG Topics:

COVID-19 Testing: CDC Guidance on Virus and Antibody Testing
How Does the Rapid Antigen Test Perform Compared to PCR for Detecting SARS-CoV-2?
How Accurate is Lateral Flow Rapid Testing for SARS-CoV-2?

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