Lab Med Qual Assur.  2022 Sep;44(3):170-173. 10.15263/jlmqa.2022.44.3.170.

Retrospective Validation of Xpert Xpress SARSCoV-2 and Rapid COVID-19 PCR Tests

• Kim YA
• Jeon CI
• Nam JH
• Lee DS
• Kang WJ
• Lee GH

• KMID: 2534081
• DOI: http://doi.org/10.15263/jlmqa.2022.44.3.170

Abstract

Background
The coronavirus disease 2019 (COVID-19) test is very important for preventing the spread of COVID-19 and optimum treatment of patients. The purpose of this study was to retrospectively validate the performance of the Xpert Xpress severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) test using test results and clinical data.
Methods
A total of 542 results of Xpert Xpress SARS-CoV-2 (a rapid test) and STANDARD M nCoV real-time detection tests (a routine and confirmatory test) were obtained from January 2021 to March 2022.
Results
The two methods showed good agreement, with a kappa value of 0.9626. The results of the Xpert Xpress SARS-CoV-2 test showed sensitivity of 99.1%, specificity of 98.7%, accuracy of 99.1%, positive predictive value of 99.8%, and negative predictive value of 95.0%, compared with that of STANDARD M nCoV Real-Time Detection test.
Conclusions
The Xpert Xpress SARS-CoV-2 test showed diagnostic performance comparable to that of routine COVID-19 real-time polymerase chain reaction. The Xpert Xpress SARS-CoV-2 test may be useful in reducing the burden of patient management and infection control for COVID-19.

Keyword

Xpert Xpress SARS-CoV-2; Real-time polymerase chain reaction; COVID-19; Verification