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KMID : 0985420220440030170
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Laboratory Medicine and Quality Assurance
2022 Volume.44 No. 3 p.170 ~ p.173
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Retrospective Validation of Xpert Xpress SARSCoV- 2 and Rapid COVID-19 PCR Tests
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Kim Young-Ah
Jeon Chan-In
Nam Ja-Hyun
Lee Da-Som
Kang Woo-Jeong
Lee Gun-Hwak
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Abstract
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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.
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KEYWORD
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Xpert Xpress SARS-CoV-2, Real-time polymerase chain reaction, COVID-19, Verification
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