Evaluation of the diagnostic accuracy of Xpert® Mpox and STANDARD™ M10 MPX/OPX for the detection of monkeypox virus

IF 14.3 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection Pub Date : 2025-02-01 DOI:10.1016/j.jinf.2025.106413

Alessandra Romero-Ramirez , Anushri Somasundaran , Konstantina Kontogianni , Jacob Parkes , Yusra Hussain , Susan Gould , Christopher T. Williams , Dominic Wooding , Richard Body , Hayley E. Hardwick , J. Kenneth Baillie , Jake Dunning , Malcolm G. Semple , CONDOR steering group, ISARIC 4C Investigators, Tom E. Fletcher , Thomas Edwards , Devy Emperador , Ana I. Cubas-Atienzar

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引用次数: 0

Abstract

Objectives

Evaluation of diagnostic accuracy of two point-of-care (POC) molecular diagnostic tests for the detection of monkeypox virus (MPXV): Xpert® Mpox (Cepheid, Inc., USA) and STANDARD™ M10 MPX/OPX (SD Biosensor, Inc., Korea).

Methods

Diagnostic accuracy of both POC platforms was evaluated using 53 upper-respiratory swabs (URS) and 32 skin lesions swabs (SS) collected from mpox and COVID-19 patients in the UK against the Sansure (Sansure Biotech Inc.) and CDC reference qPCR tests. The analytical sensitivity of both platforms was assessed using a viral isolate from II, B.1 lineage.

Results

The overall sensitivity and specificity of the Xpert® Mpox was 97.67% [95% CI 87.71–99.94%] and 88.57% [95% CI 73.26–96.80%] and 97.44% [95% CI 86.52–99.94%] and 74.42% [95% CI 58.83–86.48%] comparing the Sansure and CDC qPCR, respectively and for the M10 MPX/OPX was 87.80% [95% CI 73.80–95.92%] and 76.60% [95% CI 61.97–87.70%] and 94.29% [95% CI 80.84–99.30%] and 86.67% [95% CI 73.21–94.95%] with the Sansure and CDC qPCR.

Conclusion

The Xpert® Mpox had good diagnostic accuracy for both sample types while the M10 MPX/OPX clinical accuracy was deficient with URS. Our data supports the use of URS during the first 3 days of symptoms onset for mpox diagnosis.

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评估Xpert®Mpox和STANDARD™M10 MPX/OPX检测猴痘病毒的诊断准确性。

目的：评价两种即时护理（POC）分子诊断检测猴痘病毒（MPXV）的诊断准确性：Xpert®Mpox （Cepheid, Inc.，美国）和STANDARD™M10 MPX/OPX （SD Biosensor, Inc.，韩国）。方法：使用从英国mpox和COVID-19患者中采集的53份上呼吸道拭子（URS）和32份皮肤病变拭子（SS），对照Sansure （Sansure Biotech Inc.）和CDC参考qPCR检测，对两种POC平台的诊断准确性进行评估。使用来自II、B.1谱系的病毒分离物评估两种平台的分析敏感性。结果：与Sansure和CDC qPCR相比，Xpert®Mpox的总体敏感性和特异性分别为97.67% [95% CI 87.71-99.94%]和88.57% [95% CI 73.26-96.80%]和97.44% [95% CI 86.52-99.94%]和74.42% [95% CI 58.83-86.48%]， M10 MPX/OPX与Sansure和CDC qPCR相比，总体敏感性和特异性分别为87.80% [95% CI 73.80-95.92%]和76.60% [95% CI 61.97-87.70%]和94.29% [95% CI 80.84-99.30%]和86.67% [95% CI 73.21-94.95%]。结论：Xpert®Mpox对两种样品类型均具有良好的诊断准确性，而M10 MPX/OPX对URS的临床准确性不足。我们的数据支持在出现症状的前3天使用尿路检查进行痘诊断。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Infection 医学-传染病学

CiteScore

45.90

自引率

3.20%

发文量

475

审稿时长

16 days

期刊介绍： The Journal of Infection publishes original papers on all aspects of infection - clinical, microbiological and epidemiological. The Journal seeks to bring together knowledge from all specialties involved in infection research and clinical practice, and present the best work in the ever-changing field of infection. Each issue brings you Editorials that describe current or controversial topics of interest, high quality Reviews to keep you in touch with the latest developments in specific fields of interest, an Epidemiology section reporting studies in the hospital and the general community, and a lively correspondence section.