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比较 Credo VitaPCR™ Flu A&B 和 Cepheid Xpert® Xpress Flu/RSV 平台的实用性和分析性能。

Comparative practicability and analytical performances of Credo VitaPCR™ Flu A&B and Cepheid Xpert® Xpress Flu/RSV platforms.

机构信息

Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France; Ecole Doctorale Régionale D'Afrique Centrale en Infectiologie Tropicale, Franceville, Gabon.

Ecole Doctorale Régionale D'Afrique Centrale en Infectiologie Tropicale, Franceville, Gabon; Faculté de Médecine et Pharmacie, Université de Kisangani, Kisangani, Democratic Republic of the Congo.

出版信息

Diagn Microbiol Infect Dis. 2021 Aug;100(4):115381. doi: 10.1016/j.diagmicrobio.2021.115381. Epub 2021 Mar 22.

DOI:10.1016/j.diagmicrobio.2021.115381
PMID:33852989
Abstract

To compare the practicability (usability and satisfaction) and analytical performances of VitaPCR™ Flu A&B Assay (Credo Diagnostics Biomedical Pte. Ltd., Singapore, Republic of Singapore) and Xpert® Xpress Flu/RSV kit (Cepheid, Sunnyvale, USA), two rapid point-of-care (POC) nucleic acid amplification tests (NAATs) by reference to multiplex RT-PCR for respiratory viruses. Nasopharyngeal swabs (n=117) were collected from patients with influenza-like illness in Paris, France. Thawed specimens were further analyzed with both NAATs. The usability was comparable for both NAATs. Satisfaction questionnaire was better for the VitaPCR™ platform for the short time of test result in 20 minutes. Both NAATs showed comparable sensitivities (VitaPCR: 95.0%; Xpert® Xpress: 97.5%) and specificities (100%) for influenza A/B RNA detection, with excellent reliability and accuracy between both NAATs. Both VitaPCR™ and Xpert® Xpress NAATs can be implemented in hospital setting as POC NAATs to rapidly detect influenza A/B RNA in symptomatic patients.

摘要

比较 VitaPCR™ Flu A&B 检测试剂盒(新加坡 Credo 诊断生物医学私人有限公司)和 Xpert® Xpress Flu/RSV 试剂盒(美国 Cepheid)这两种快速即时检测(POC)核酸扩增检测技术(NAAT)的实用性(可用性和满意度)和分析性能,该两种检测方法均参照呼吸道病毒多重 RT-PCR 作为参考。从法国巴黎流感样疾病患者中采集鼻咽拭子(n=117)。解冻后的标本用两种 NAAT 进一步分析。两种 NAAT 的可用性相当。VitaPCR™ 平台的满意度问卷调查更好,因为其在 20 分钟内即可得到检测结果。对于流感 A/B RNA 的检测,两种 NAAT 的敏感性(VitaPCR:95.0%;Xpert® Xpress:97.5%)和特异性(100%)相当,两种方法之间具有极好的可靠性和准确性。VitaPCR™ 和 Xpert® Xpress NAAT 均可在医院环境中作为 POC NAAT 用于快速检测有症状患者的流感 A/B RNA。

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