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

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.

Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: a systematic review and meta-analysis

“…The search for studies in study registries allowed us to identify four planned or ongoing and four completed studies with no results posted, see online supplemental table S4 of Appendix 1 for further details. Information retrieval from other information sources included screening 18 records retrieved from the FIND website, 78 records from NICE Evidence Search, 28 records from NICE Guidance, and 23 records from reference lists of six systematic reviews8 55–59 identified via searching bibliographical databases. As a result, no additional study that met the inclusion criteria was identified.…”

Three SARS-CoV-2 PCR-negative cases of COVID-19 diagnosed using isothermal amplification methods

“…Considering that the sensitivity and specificity of PCR tests for detection of SARS-CoV-2 were 99% (95% confidence interval [CI], 97–99%) and 97% (95% CI, 95–98%), PCR tests are the most reliable test, but ID-Now and LAMP are superior in terms of cost and time consumption as many patients are checked at admission [ 15 ].…”

The Impact of False Positive COVID-19 Result

“…The first RT-PCR was conducted upon her admission to the emergency department. It was done using the Xpert® Xpress SARS-CoV-2 kit (Cepheid, California, US) used and processed in our hospital with a sensitivity of 99% And specificity of 97% [12]. The other test was performed on the next day of admission.…”