Evaluation of the diagnostic performance of a commercial molecular assay for the screening of suspected monkeypox cases in Sri Lanka

Infectious Medicine Pub Date : 2023-06-01 DOI:10.1016/j.imj.2023.05.002

H.B.C. Harshani, G.A. Liyanage, D.V.R.G. Ruwan, U.K.I.U. Samaraweera, J.I. Abeynayake

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Abstract

Background

The main objective of the present study was to compare the diagnostic performance of the commercial LightMix Modular Monkeypox Virus (MPXV) qPCR (TIB Molbiol, Germany) assay with the in-house nonvariola orthopox/monkeypox generic real-time PCR assay (ICMR-NIV, Pune) for the screening of (MPXV) cases at Medical Research Institute (MRI) in Sri Lanka. Furthermore, clinical and sociodemographic data of suspected /confirmed cases received at MRI for the MPXV screening were also analyzed.

Methods

The diagnostic performance of the commercial LightMix Modular MPXV qPCR assay with the in-house nonvariola orthopox/monkeypox generic real-time PCR assay for the screening of suspected MXPV cases was evaluated using standard methods with minor modifications. Socio-demographic and clinical profiles of suspected and confirmed MPXV cases were also analyzed.

Results

The commercial LightMix Modular MPXV assay was able to detect MPXV with 100% sensitivity and specificity with non-variola orthopox/monkeypox generic rtPCR assay. During the period of study, from the total of 25 samples tested, only 2 were MPXV-positive (males). The most common symptoms of suspected MPXV cases were lesions or rashes (92%).

Conclusions

With the continually increasing number of cases, access to MPXV testing should be made more widely available. The commercial LightMix Modular MPXV (TIB Molbiol) qPCR assay offers comparable performance to the non-variola orthopox/monkeypox generic real time PCR assay for MPXV detection during the present outbreak.

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斯里兰卡筛查猴痘疑似病例的商业分子检测诊断性能评估

背景本研究的主要目的是比较商业LightMix模块化猴痘病毒（MPXV）qPCR（TIB Molbiol，德国）检测法与斯里兰卡医学研究所（MRI）内部非变体正痘/猴痘通用实时PCR检测法（ICMR-NIV，浦那）的诊断性能。此外，还分析了在MRI中接受MPXV筛查的疑似/确诊病例的临床和社会人口学数据。方法使用标准方法对商业LightMix Modular MPXV-qPCR检测法与内部非变异性正痘/猴痘通用实时PCR检测法筛查疑似MXPV病例的诊断性能进行评估，并稍作修改。还分析了疑似和确诊MPXV病例的社会人口学和临床特征。结果商业LightMix模块化MPXV检测方法能够以100%的灵敏度和特异性检测MPXV。在研究期间，在总共检测的25个样本中，只有2个MPXV阳性（男性）。疑似MPXV病例最常见的症状是病变或皮疹（92%）。结论随着病例数量的不断增加，应更广泛地进行MPXV检测。商业LightMix Modular MPXV（TIB Molbiol）qPCR检测在当前疫情期间提供了与非天花正痘/猴痘通用实时PCR检测MPXV相当的性能。

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

Infectious Medicine

CiteScore

1.40

自引率

0.00%

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