02615nas a2200277 4500000000100000008004100001260001600042653003500058653002000093653002200113653001200135653003900147100001600186700001700202700001400219700001600233700001900249700001600268700001300284245020600297856007200503300001100575490000800586520172900594022001402323 2025 d bElsevier BV10aClinical Laboratory Techniques10aEarly diagnosis10aMolecular Biology10aLeprosy10aMultiple Polymerase Chain Reaction1 aBrandão JG1 ade Macedo AC1 aSousa GJB1 aBarbosa PPL1 aEvangelista PE1 aMassanti TB1 aGomes CM00aAccuracy 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 uhttps://www.sciencedirect.com/science/article/pii/S0732889325002524 a1169290 v1133 a

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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