DIAGNOSTIC PERFORMANCE OF A POINT-OF-CARE MOLECULAR SYSTEM FOR THE DETECTION OF SARSCOV-2 IN PERU

被引:0
作者
Puyen, Zully M. [1 ,2 ]
Araujo-Castillo, Roger [1 ]
Giraldo, Jorge [1 ]
Gutierrez, Karina [1 ]
Rojas-Serrano, Nancy [1 ]
机构
[1] Inst Nacl Salud, Lima, Peru
[2] Univ Peruana Ciencias Aplicadas, Escuela Med, Lima, Peru
来源
REVISTA PERUANA DE MEDICINA EXPERIMENTAL Y SALUD PUBLICA | 2024年 / 41卷 / 01期
关键词
SARS-CoV-2; COVID-19; Molecular Diagnostic Techniques; PCR; Sensitivity and Specifici- ty; Peru;
D O I
10.17843/rpmesp.2024.411.13046
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
The present study assessed the diagnostic performance of the Xpert (R) Xpress SARS-CoV-2 test in comparison with the Charit & eacute; protocol real-time RT PCR for the detection of SARS-CoV-2 in Peruvian patients. This was a diagnostic test study that included 100 nasal and pharyngeal swab samples. We obtained an overall concordance of 98.70% (95%CI: 92.98-99.97), with a kappa coefficient of 0.97 (95%CI: 0.861.00) and sensitivity and relative specificity rates of 100% and 96.15%, respectively. Additionally, the percentage of the area under the ROC curve was 98.08% in both cases, and an analytical specificity rate of 100% was obtained for the different respiratory viruses evaluated. In conclusion, the Xpert (R) Xpress SARS-CoV-2 test, by using nasal and pharyngeal swab samples, was highly sensitive and specific, and the kappa coefficient showed an excellent correlation when compared to the reference test.
引用
收藏
页码:76 / 82
页数:7
相关论文
共 22 条
[1]  
[Anonymous], 2021, Xpert Xpress SARS-Cov-2. Test package insert
[2]  
FIND, 2020, COVID-19 NAT Evaluation Protocol Summary
[3]   Impact of the diagnostic test Xpert MTB/RIF on patient outcomes for tuberculosis [J].
Haraka, Frederick ;
Kakolwa, Mwaka ;
Schumacher, Samuel G. ;
Nathavitharana, Ruvandhi R. ;
Denkinger, Claudia M. ;
Gagneux, Sebastien ;
Reither, Klaus ;
Ross, Amanda .
COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2021, (05)
[4]   Coronavirus disease 2019: What we know? [J].
He, Feng ;
Deng, Yu ;
Li, Weina .
JOURNAL OF MEDICAL VIROLOGY, 2020, 92 (07) :719-725
[5]   Comparison of Commercially Available and Laboratory-Developed Assays for In Vitro Detection of SARS-CoV-2 in Clinical Laboratories [J].
Lieberman, Joshua A. ;
Pepper, Gregory ;
Naccache, Samia N. ;
Huang, Meei-Li ;
Jerome, Keith R. ;
Greninger, Alexander L. .
JOURNAL OF CLINICAL MICROBIOLOGY, 2020, 58 (08)
[6]  
Liu Y, 2020, LANCET INFECT DIS, V20, P656, DOI [10.1016/S1473-3099(20)30232-2, 10.1016/S1473-3099(15)00424-7]
[7]   Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test [J].
Loeffelholz, Michael J. ;
Alland, David ;
Butler-Wu, Susan M. ;
Pandey, Utsav ;
Perno, Carlo Frederico ;
Nava, Alice ;
Carroll, Karen C. ;
Mostafa, Heba ;
Davies, Emma ;
McEwan, Ashley ;
Rakeman, Jennifer L. ;
Fowler, Randal C. ;
Pawlotsky, Jean-Michel ;
Fourati, Slim ;
Banik, Sukalyani ;
Banada, Padmapriya P. ;
Swaminathan, Shobha ;
Chakravorty, Soumitesh ;
Kwiatkowski, Robert W. ;
Chu, Victor C. ;
Kop, JoAnn ;
Gaur, Rajiv ;
Sin, Mandy L. Y. ;
Duy Nguyen ;
Singh, Simranjit ;
Zhang, Na ;
Persing, David H. .
JOURNAL OF CLINICAL MICROBIOLOGY, 2020, 58 (08)
[8]   Viral dynamics of SARS-CoV-2 across a spectrum of disease severity in COVID-19 [J].
Lui, Grace ;
Ling, Lowell ;
Lai, Christopher K. C. ;
Tso, Eugene Y. K. ;
Fung, Kitty S. C. ;
Chan, Veronica ;
Ho, Tracy Hy ;
Luk, Fion ;
Chen, Zigui ;
Ng, Joyce K. C. ;
Chow, Kai-Ming ;
Cheng, Peter K. C. ;
Chan, Rickjason C. W. ;
Tsang, Dominic N. C. ;
Gomersall, Charles D. ;
Hui, David S. C. ;
Chan, Paul K. S. .
JOURNAL OF INFECTION, 2020, 81 (02) :324-327
[9]  
Marcos Pool, 2017, Rev. perú. med. exp. salud publica, V34, P192, DOI 10.17843/rpmesp.2017.342.2054
[10]   Detection of SARS-CoV-2 by Use of the Cepheid Xpert Xpress SARS-CoV-2 and Roche cobas SARS-CoV-2 Assays [J].
Moran, Angelica ;
Beavis, Kathleen G. ;
Matushek, Scott M. ;
Ciaglia, Carol ;
Francois, Nina ;
Tesic, Vera ;
Love, Nedra .
JOURNAL OF CLINICAL MICROBIOLOGY, 2020, 58 (08)