Diagnostic accuracy of the Cepheid Xpert Xpress and the Abbott ID NOW assay for rapid detection of SARS-CoV-2: A systematic review and meta-analysis

J Med Virol. 2021 Jul;93(7):4523-4531. doi: 10.1002/jmv.26994. Epub 2021 May 3.

Abstract

Rapid and accurate diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is essential to prevent the spread of the virus. We investigated the diagnostic accuracy of the Xpert Xpress and the ID NOW assays for rapid detection of SARS-CoV-2 using a systemic review and meta-analysis approach. A systematic literature search was performed using PubMed, Embase, and the Cochrane COVID-19 Study Register. The sensitivity and specificity of these tests for detecting viruses in patients with suspected SARS-CoV-2 infection were pooled. We used commercial and laboratory-developed reverse transcription-polymerase chain reactions as reference standards. The Quality Assessment of Diagnostic Accuracy Studies-2 tool was used to assess the risk of bias. We identified 11 studies involving 1734 subjects for the Xpert Xpress assay and 10 studies involving 1778 subjects for the ID NOW assay. The pooled sensitivity and specificity of the Xpert Xpress assay for detection of SARS-CoV-2 were 0.99 (95% confidence interval [CI], 0.97 to 0.99) and 0.97 (95% CI, 0.95 to 0.98), respectively. The pooled sensitivity and specificity of the ID NOW assay were 0.79 (95% CI, 0.69 to 0.86) and 1.00 (95% CI, 0.98 to 1.00), respectively. The studies included in our analysis seemed to have low methodological quality. The Xpert Xpress assay showed excellent diagnostic accuracy for rapid detection of SARS-CoV-2. However, as the ID NOW assay showed relatively low sensitivity, this test might miss several positive samples.

Keywords: COVID-19 testing; SARS-CoV-2; diagnosis; point-of-care testing; reverse transcription polymerase chain reaction.

Publication types

  • Evaluation Study
  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Systematic Review

MeSH terms

  • COVID-19 / diagnosis*
  • COVID-19 Testing / methods*
  • Coronavirus Envelope Proteins / genetics
  • Coronavirus Nucleocapsid Proteins / genetics
  • Humans
  • Molecular Diagnostic Techniques / methods*
  • Nucleic Acid Amplification Techniques / methods*
  • Phosphoproteins / genetics
  • Reverse Transcriptase Polymerase Chain Reaction
  • SARS-CoV-2 / genetics
  • SARS-CoV-2 / isolation & purification*
  • Sensitivity and Specificity

Substances

  • Coronavirus Envelope Proteins
  • Coronavirus Nucleocapsid Proteins
  • Phosphoproteins
  • envelope protein, SARS-CoV-2
  • nucleocapsid phosphoprotein, SARS-CoV-2