Accuracy of the newly manufactured multiplex XGEN MASTER LEPRAE molecular kit and the point-of-care Bioclin FAST ML FLOW test for case definition and early diagnosis of leprosy among household contacts

IF 2.1 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2025-06-05 DOI:10.1016/j.diagmicrobio.2025.116929

Jurema Guerrieri Brandão , Alexandre Casimiro de Macedo , George Jó Bezerra Sousa , Patrícia Pereira Lima Barbosa , Patrícia Estrela Evangelista , Thiago Brobio Massanti , Ciro Martins Gomes

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引用次数: 0

Abstract

Background

Close household contact with multibacillary leprosy is the primary risk factor for disease transmission. Therefore, early detection of leprosy is crucial for disrupting the transmission chain. The primary objective of this study was to evaluate the diagnostic accuracy of the multiplex XGEN MASTER LEPRAE kit (XGEN) and the point-of-care Bioclin FAST ML FLOW Hanseníase test (PoC-ML-FLOW) among household contacts (HHCs) of leprosy index cases in midwestern Brazil.

Methods

We included HHCs of leprosy index cases. After the application of a composite reference standard comprising clinical and laboratory examinations, HHCs were divided into patients with leprosy and controls. The diagnostic accuracy was evaluated using the XGEN and PoC-ML-FLOW.

Results

We included 314 HHCs. Twenty-two HHCs (7%) were diagnosed with leprosy. The PoC-ML-FLOW demonstrated a sensitivity of 45.45% and a specificity of 74.91%. The XGEN test exhibited a sensitivity of 42.11% and a specificity of 100%. The XGEN test was positive in 5 patients with a negative classical slit-skin smear. Furthermore, in our sample, the number of bacilli per reaction detected as positive by the qualitative XGEN kit detected ranged from 3.85 to 21,533.30.

Conclusion

This study demonstrated the ability of both the PoC-ML-FLOW and XGEN tests, along with clinical exams, to diagnose leprosy among HHCs. The use of the XGEN test in the definition of leprosy cases demonstrated a specificity of 100%, with a significant increase in sensitivity when associated with slit-skin smears.

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新生产的多重XGEN MASTER LEPRAE分子试剂盒和即时护理bioclinfast ML FLOW检测用于家庭接触者中麻风病例定义和早期诊断的准确性

背景：与多杆菌性麻风的家庭密切接触是疾病传播的主要危险因素。因此，早期发现麻风病对于破坏传播链至关重要。本研究的主要目的是评估多重XGEN MASTER LEPRAE试剂盒（XGEN）和即时护理biocin FAST ML FLOW Hanseníase检测（PoC-ML-FLOW）在巴西中西部麻风指数病例的家庭接触者（hhc）中的诊断准确性。方法纳入麻风指数病例的hhc。应用由临床和实验室检查组成的综合参考标准后，将hhc分为麻风患者和对照组。使用XGEN和PoC-ML-FLOW评估诊断准确性。结果纳入314例hhc。22名hhc（7%）被诊断为麻风病。PoC-ML-FLOW的敏感性为45.45%，特异性为74.91%。XGEN试验灵敏度为42.11%，特异性为100%。5例经典裂皮涂片阴性患者XGEN试验阳性。此外，在我们的样本中，每个反应被定性XGEN试剂盒检测到的阳性杆菌数在3.85到21,533.30之间。结论：本研究证明了PoC-ML-FLOW和XGEN检测以及临床检查在hhc中诊断麻风病的能力。在麻风病病例的定义中使用XGEN测试显示出100%的特异性，当与裂口皮肤涂片相关时，敏感性显着增加。

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

Diagnostic microbiology and infectious disease 医学-传染病学

CiteScore

5.30

自引率

3.40%

发文量

149

审稿时长

56 days

期刊介绍： Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.