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pISSN 2950-9114 eISSN 2950-9122
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Original Article

Lab Med Qual Assur 2022; 44(3): 170-173

Published online September 30, 2022

https://doi.org/10.15263/jlmqa.2022.44.3.170

Copyright © Korean Association of External Quality Assessment Service.

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

Young Ah Kim , Chan In Jeon , Ja Hyun Nam , Da Som Lee , Woo Jeong Kang , and Gun Hwak Lee

Department of Laboratory Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea

Correspondence to:Young Ah Kim
Department of Laboratory Medicine, National Health Insurance Service Ilsan Hospital, 100 Ilsan-ro, Ilsandong-gu, Goyang 10444, Korea
Tel +82-31-900-0908
E-mail yakim@nhimc.or.kr

Received: May 27, 2022; Revised: June 9, 2022; Accepted: June 10, 2022

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: Xpert Xpress SARS-CoV-2, Real-time polymerase chain reaction, COVID-19, Verification

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