皮肤拭子分子检测作为皮肤利什曼病的一种有效、非侵入性诊断技术:意大利一项回顾性研究的结果
Molecular Assays on Cutaneous Swabs as an Effective, Non-Invasive Diagnostic Technique for Cutaneous Leishmaniasis: Results from a Retrospective Study Conducted in Italy.
作者信息
Barbiero Anna, Aiello Andrea, Ciccone Nunziata, Pollini Simona, Malentacchi Francesca, Colao Maria Grazia, Rossolini Gian Maria, Fiorelli Costanza, Massi Daniela, Antonelli Alberto, Cuffari Sara, Di Muccio Trentina, Bartoloni Alessandro, Spinicci Michele, Zammarchi Lorenzo
机构信息
Department of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50134 Florence, Italy.
Microbiology and Virology Unit, Careggi University Hospital, Largo Brambilla 3, 50134, Florence, Italy.
出版信息
Trop Med Infect Dis. 2025 Jun 9;10(6):158. doi: 10.3390/tropicalmed10060158.
BACKGROUND
The case confirmation of CL relies on the direct demonstration of the parasite in clinical specimens from skin tissues. Despite most research efforts focusing on biopsy samples as the preferred diagnostic specimen for the detection of spp., the use of non-invasive sampling, such as cutaneous swabs, combined with the use of molecular assays, has shown promising results.
METHODS
We conducted a retrospective study aimed at comparing the performance of different invasive and non-invasive diagnostic techniques, employed for the diagnosis of CL, in an Italian tertiary care center.
RESULTS
We observed 29 cases of CL between 2008 and June 2024. Considering the demonstration of spp. on culture, biopsy PCR, histology, or smear microscopy as the reference diagnostic test for CL, molecular assays on cutaneous swabs showed a sensitivity of 100% (95% C.I. 73.5-100). Overall, PCR performed on swab specimens allowed for the detection of three cases that biopsy histology (in two cases) and microscopic examination of cutaneous smear (in three cases) would have failed to identify.
CONCLUSION
Non-invasive swab sampling, combined with molecular analysis, can be a valuable tool for a more accessible and patient-friendly diagnostic approach for CL. Should our preliminary results be confirmed, this test could become the first-line diagnostic tool for CL, reserving biopsy as a second-level test or for cases in which the differential diagnosis includes malignancy or other concerning diseases. Further studies aimed at defining the efficiency of this diagnostic method and providing standardized diagnostic protocols would be needed to provide stronger evidence supporting its recommendation.
背景
皮肤利什曼病(CL)的病例确诊依赖于在皮肤组织临床标本中直接发现寄生虫。尽管大多数研究工作聚焦于将活检样本作为检测利什曼原虫属物种的首选诊断标本,但使用非侵入性采样(如皮肤拭子)并结合分子检测方法已显示出有前景的结果。
方法
我们在一家意大利三级护理中心开展了一项回顾性研究,旨在比较用于CL诊断的不同侵入性和非侵入性诊断技术的性能。
结果
我们在2008年至2024年6月期间观察到29例CL病例。将在培养物、活检PCR、组织学或涂片显微镜检查中发现利什曼原虫属物种作为CL的参考诊断测试,皮肤拭子的分子检测显示敏感性为100%(95%置信区间73.5 - 100)。总体而言,对拭子标本进行的PCR检测出了3例活检组织学(2例)和皮肤涂片显微镜检查(3例)未能识别的病例。
结论
非侵入性拭子采样结合分子分析,对于CL而言,可能是一种更易获取且对患者更友好的诊断方法的有价值工具。如果我们的初步结果得到证实,该检测可能成为CL的一线诊断工具,将活检保留为二级检测或用于鉴别诊断包括恶性肿瘤或其他相关疾病的病例。需要进一步开展研究以确定这种诊断方法的效率并提供标准化诊断方案,从而为推荐该方法提供更有力的证据。