Diagnostic microbiology and infectious disease最新文献

{"title":"Improving diagnostic accuracy in visceral leishmaniasis: Chimeric protein-based approach","authors":"Mariana Costa Duarte ,&nbsp;Isabela de Andrade Ferraz ,&nbsp;Ana Maria Ravena Severino Carvalho ,&nbsp;Tiago Antônio de Oliveira Mendes ,&nbsp;Fernanda Alvarenga Cardoso Medeiros ,&nbsp;Níbia Mariana Eleutério ,&nbsp;Matheus Fernandes Costa-Silva ,&nbsp;Eduardo Antonio Ferraz Coelho ,&nbsp;Manoel Otávio da Costa Rocha ,&nbsp;Daniel Menezes-Souza","doi":"10.1016/j.diagmicrobio.2025.116948","DOIUrl":"10.1016/j.diagmicrobio.2025.116948","url":null,"abstract":"<div><div>Endemic to Brazil, Human Visceral Leishmaniasis (HVL), caused by <em>Leishmania infantum</em> and vectored by sand flies, is characterized by a complex and often overlapping set of symptoms, including prolonged fever, weight loss, organomegaly, anaemia, and bleeding. The diagnostic process for HVL is frequently hindered by the disease's nonspecific clinical presentation and the inherent limitations of existing serological assays, which often exhibit suboptimal sensitivity and specificity, predisposing to diagnostic inaccuracies. Developing of sensitive and specific diagnostic assays is crucial for effective HVL control in Brazil, enabling early disease detection and improving treatment outcomes. To enhance diagnostic capabilities, we evaluated the performance of a chimeric protein designed from B-lymphocyte cell epitopes identified through immunoproteomic analysis in serological tests for detecting <em>L. infantum</em> infection. Under the experimental conditions, the chimeric protein demonstrated the following diagnostic performance: 100 % specificity against control samples, 94.12 % specificity against Chagas disease samples, and 100 % sensitivity for HVL-positive individuals. Receiver Operating Characteristic (ROC) curve analysis demonstrated the following performance metrics: area under the curve (AUC) of 0.9960, 100 % sensitivity, and 97.10 % overall specificity, significantly exceeding the performance of the <em>L. infantum</em> soluble antigen (SLiA) ELISA. These findings suggest that the chimeric protein represents a promising antigen for developing of improved HVL diagnostic technologies, potentially reducing the disease's public health impact.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116948"},"PeriodicalIF":2.1,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144279515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Primary isolated laryngeal tuberculosis: A rare extrapulmonary manifestation","authors":"Dr. Garima Rawat ,&nbsp;Dr. Aditi Shukla ,&nbsp;Dr. Hema Malini Aiyer","doi":"10.1016/j.diagmicrobio.2025.116951","DOIUrl":"10.1016/j.diagmicrobio.2025.116951","url":null,"abstract":"<div><div>Laryngeal tuberculosis (TB) is a rare form of extrapulmonary tuberculosis and its isolated presentation without concurrent pulmonary involvement is even rare [1, 2] This poses significant diagnostic challenges as it can present with nonspecific symptoms such as hoarseness, throat pain or dysphagia. In this report, we highlight the case of a 42-year-old female who presented with a history of a change in voice, which was eventually diagnosed as isolated primary laryngeal tuberculosis post investigations.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116951"},"PeriodicalIF":2.1,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144313949","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Scrub typhus (Orientia tsutsugamushi)-associated intracranial infection: a case report and review of diagnostic and therapeutic challenges","authors":"Hang Yu ,&nbsp;Zhi-Kun Luo ,&nbsp;Ting-Ting Lu ,&nbsp;Yue Deng ,&nbsp;Jia-Ni Xia ,&nbsp;Wan-Yue Li ,&nbsp;Jing-Hao Li","doi":"10.1016/j.diagmicrobio.2025.116950","DOIUrl":"10.1016/j.diagmicrobio.2025.116950","url":null,"abstract":"<div><div>Intracranial infections caused by <em>Orientia tsutsugamushi (O. tsutsugamushi)</em>, the causative agent of scrub typhus, are rare but potentially fatal. This case report describes a 45-year-old male patient presenting with persistent fever, headache, altered mental status, and skin lesions. High-throughput sequencing of cerebrospinal fluid confirmed <em>O. tsutsugamushi</em>, while respiratory samples detected <em>Pseudomonas aeruginosa</em> and <em>Aspergillus fumigatus</em>, suggesting a mixed bacterial and fungal infection. After timely adjustment of anti-infective treatment, the patient's condition significantly improved. This case emphasizes the importance of early recognition and molecular diagnosis in the management of complex infections, and highlights the key role of typical signs, such as erythema on the lower back, in the early diagnosis in endemic areas.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116950"},"PeriodicalIF":2.1,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144279516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Molecular study of candiduria in pediatric patients in in relation to biofilm formation and fluconazole tolerance","authors":"Rasha H. ElKenawy ,&nbsp;Maysaa El Sayed Zaki ,&nbsp;Sara Ghaleb Essa ,&nbsp;Noha Mostafa Mahmoud ,&nbsp;Ahmed Hazem El-Nagdy ,&nbsp;Mona Abdellatif ,&nbsp;Mayada Sabry Zeid","doi":"10.1016/j.diagmicrobio.2025.116943","DOIUrl":"10.1016/j.diagmicrobio.2025.116943","url":null,"abstract":"<div><h3>Background</h3><div>There are limited studies about the presence of <em>Candida</em> species <em>(Candida</em> spp.<em>)</em> and ABC genotypes in hospital acquired urinary tract infection (UTI) in children.</div></div><div><h3>Aim</h3><div>the study aimed at identification of <em>Candida spp.</em> associated with candiduria in children, detection of fluconazole tolerance and biofilm formation and genotyping of <em>C. albicans</em>.</div></div><div><h3>Method</h3><div>The study was conducted on pediatric patients with hospital-acquired UTI. A urine sample was cultured on the agar CHROM <em>Candida</em>. Molecular identification of <em>Candida spp.</em> was performed by nested polymerase chain reaction (PCR) and specific genotyping of C. albicans was performed by PCR. Biofilm production and fluconazole tolerance were tested for the isolates.</div></div><div><h3>Results</h3><div>97 children were included. Urinary catheters were inserted reported in 69.1 % of the children and previous antibiotic intake was reported in 34 % of them. The identified species were <em>C. albicans</em> (66 %) followed by <em>Nakaseomyces glabrat</em>a (19.6 %), <em>Candida tropicalis</em> (11.3 %) and <em>Candida kruzei</em> (3.1 %). The ability of biofilm formation was 100 %<em>.</em> The <em>Pichia kudriavzevii</em> had a highest significant rate of fluconazole tolerance (66.7%), (P=0.045). Resistance to fluconazole was observed significantly with <em>C. tropicalis</em> (63.6%), (P=0.033). The common genotypes of <em>C. albicans</em> were A (60.9%) and C (39.1%). There was significant capacity of <em>C. albicans</em> genotype C to form strong biofilm (P&lt;0.001).</div></div><div><h3>Conclusion</h3><div>The study found that <em>C. albicans</em> remains the most prevalent species in candiduria. The ability of <em>Candida spp.</em> to form biofilms was 100% among the isolates. Strong biofilm formation being significantly associated with increased fluconazole resistance and <em>C. albicans</em> genotype C.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116943"},"PeriodicalIF":2.1,"publicationDate":"2025-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144263477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diaper-based diagnostics: A novel non-invasive method for urine collection and molecular testing of uropathogens","authors":"Tyler Vine ,&nbsp;Rob E. Carpenter ,&nbsp;Debbie Bridges","doi":"10.1016/j.diagmicrobio.2025.116939","DOIUrl":"10.1016/j.diagmicrobio.2025.116939","url":null,"abstract":"<div><div>Urinary tract infections (UTIs) present a global diagnostic challenge, especially in populations where midstream urine collection is impractical. This study evaluates sodium polyacrylate-based diapers as a non-invasive matrix for urine collection, coupled with quantitative PCR (qPCR) for uropathogen detection. Phase I involved 17 samples (7 contrived, 10 from diaper-wearing volunteers), and Phase II analyzed 35 de-identified clinical specimens using a CLIA/CAP-validated qPCR panel targeting 17 bacteria, 4 fungi, 6 antimicrobial resistance genes, and 1 control gene. Diaper-derived samples demonstrated 100 % concordance in positive and negative predictive values with standard urine specimens. Across all clinical samples, mean cycle threshold (Ct) differences ranged from –2.06 to 3.87 (mean absolute difference = 1.43), with lower variability in diaper samples (SD = 4.02 vs. 4.48) and strong correlation in Ct values (<em>r</em> = 0.97). These findings validate the diaper matrix as a clinically robust, non-invasive alternative that maintains diagnostic integrity under simulated transport and storage. This approach enables accurate molecular detection of uropathogens while minimizing invasive procedures, offering immediate applicability for infants, the elderly, and individuals with incontinence—thereby enhancing diagnostic access, accuracy, and antimicrobial stewardship in vulnerable populations.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116939"},"PeriodicalIF":2.1,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144240127","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Concurrent chromoblastomycosis and subcutaneous phaeohyphomycosis by different pathogens in a renal transplant recipient","authors":"Harsimran Kaur ,&nbsp;Karthick Kumar ,&nbsp;Haseen Ahmad ,&nbsp;Ashish Sharma ,&nbsp;Nalini Gupta ,&nbsp;Charvi Gupta ,&nbsp;Tarun Narang ,&nbsp;Jasmine Sethi ,&nbsp;Sourav Agnihotri ,&nbsp;Radhika Srinivasan ,&nbsp;Shivaprakash M Rudramurthy","doi":"10.1016/j.diagmicrobio.2025.116945","DOIUrl":"10.1016/j.diagmicrobio.2025.116945","url":null,"abstract":"<div><div>Chromoblastomycosis and subcutaneous phaeohyphomycosis are implantation mycoses caused by melanized fungi. We present a unique case of concurrent chromoblastomycosis by <em>Fonsecaea monophora</em> and phaeohyphomycosis by <em>Medicopsis romeroi</em> presenting as polypoidal wrist lesion and painless cystic toe lesion respectively in a renal transplant recipient. The diagnosis was confirmed by microbiological (including molecular identification by sequencing of ITS region of rDNA) and histopathological examination. The wrist lesion was surgically excised. Oral itraconazole and topical luliconazole led to healing of both lesions within six months of therapy. This case highlights the emergence of rare opportunistic fungal pathogens causing concurrent skin infections in an immunocompromised patient. This warrants investigation of their epidemiology and virulence to implement preventive measures in renal transplant recipients.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116945"},"PeriodicalIF":2.1,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144262895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating clinical outcome in non-HIV associated cryptococcal meningitis with negative CSF culture using microscopic quantitative cryptococcal counting","authors":"Junyu Liu ,&nbsp;Jia Liu ,&nbsp;Li Xu ,&nbsp;Lu Yang ,&nbsp;Xiaohong Su ,&nbsp;Yaxin Lu ,&nbsp;Dongcheng Li ,&nbsp;Zheqi Li ,&nbsp;Chu Peng HOI ,&nbsp;Ying Jiang ,&nbsp;Fuhua Peng","doi":"10.1016/j.diagmicrobio.2025.116944","DOIUrl":"10.1016/j.diagmicrobio.2025.116944","url":null,"abstract":"<div><h3>Background</h3><div>Non-HIV associated cryptococcal meningitis (CM) patients with negative cerebrospinal fluid (CSF) culture lack validated biomarkers for outcome assessment. Baseline CSF cryptococcal count via India ink staining correlate with disease progression, but the role of cryptococcal clearance rate remains unclear in this population.</div></div><div><h3>Methods</h3><div>We retrospectively collected data from 594 non-HIV associated CM patients from the Third Affiliated Hospital of Sun Yat-sen University. 111 non-HIV associated CM patients with negative CSF culture were included to analyse. We focused on analyzing the association between cryptococcal clearance rate and outcome.</div></div><div><h3>Result</h3><div>Baseline high log₁₀ CSF cryptococcal count (OR: 2.939, 95%CI 1.574-5.488, p=0.001) and slow rate of cryptococcal clearance (OR: 92.228, 95%CI 6.453-1318.128, p=0.001) were associated with unsuccessful outcomes at 2 weeks after admission. The baseline high log₁₀ CSF cryptococcal count (OR: 1.520, 95%CI 1.045-2.211, p=0.029), slow rate of cryptococcal clearance (OR: 162.896, 95%CI 10.028-2646.031, p=0.001) and hearing impairment at baseline (OR: 8.683, 95%CI 1.294-58.291, p=0.026) were associated with unsuccessful outcomes at 10 weeks after admission. And hearing impairment at baseline (log-rank test, p=0.007), baseline log₁₀ CSF cryptococcal count ≥1.52/ml (log-rank test, p=0.033) were associated with no clinical cure within 1 year after admission.</div></div><div><h3>Conclusion</h3><div>Rate of cryptococcal clearance based on India ink staining may be a marker for short-term outcomes in non-HIV associated CM patients with negative CSF culture. Monitoring this marker may optimize clinical management in this challenging subgroup. Notably, its strengthened association at 10 weeks reflects sustained prognostic value, while the attenuated effect of baseline count suggests diminishing early impact.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116944"},"PeriodicalIF":2.1,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144262894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fannyhessea vaginae bacteremia following transvaginal procedures: A rare complication in assisted reproductive technology","authors":"Naoki Okawa ,&nbsp;Mutsuka Kurihara ,&nbsp;Rika Kurata ,&nbsp;Emiri Muranaka ,&nbsp;Yuji Nishihara ,&nbsp;Kosuke Ito ,&nbsp;Yasunobu Endo ,&nbsp;Ryota Hase","doi":"10.1016/j.diagmicrobio.2025.116947","DOIUrl":"10.1016/j.diagmicrobio.2025.116947","url":null,"abstract":"<div><h3>Background</h3><div><em>Fannyhessea vaginae</em> is commonly found in vaginal flora and associated with bacterial vaginosis, but rarely causes invasive infections. Few cases of <em>F. vaginae</em> bacteremia have been reported, primarily in the context of pregnancy or gynecological procedures.</div></div><div><h3>Case</h3><div>A 40-year-old woman presented with fever and right lower abdominal pain two weeks after undergoing transvaginal procedures for assisted reproductive technology. She had no symptoms of bacterial vaginosis. Magnetic resonance imaging revealed a 9 cm tubo-ovarian mass. Blood cultures and surgical specimens grew gram-positive cocci, later identified as <em>F. vaginae</em>. The patient recovered following right salpingo-oophorectomy and seven days of cefmetazole therapy.</div></div><div><h3>Conclusion</h3><div>This case demonstrates that <em>F. vaginae</em> can cause serious infections following transvaginal procedures, even in the absence of symptoms of bacterial vaginosis. Clinicians should consider <em>F. vaginae</em> as a potential pathogen in post-gynecological procedure infections, particularly when anaerobic blood cultures become positive.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116947"},"PeriodicalIF":2.1,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144271164","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The usefulness of fast point-of-care tests detecting calprotectin in synovial fluid for diagnosing periprosthetic joint infections","authors":"Katarzyna Prokop ,&nbsp;Rafał Mazur ,&nbsp;Aleksandra Grajek ,&nbsp;Piotr Sypień ,&nbsp;Dariusz Grzelecki","doi":"10.1016/j.diagmicrobio.2025.116942","DOIUrl":"10.1016/j.diagmicrobio.2025.116942","url":null,"abstract":"<div><h3>Objective</h3><div>Among different, recently investigated biomarkers calprotectin (CLP) is one of the most promising indicator of periprosthetic joint infections (PJI). This study aims to evaluate the optimal cut-off values and efficacy of two (strip and cassette), semi-quantitative point-of-care (POC) tests detecting CLP for diagnosing chronic PJI.</div></div><div><h3>Methods</h3><div>A total number of 98 patients (38 with PJI and 60 operated on due to aseptic reasons) were included in the analysis. All synovial fluid samples were tested off-label (synovial fluid samples were tested with tests dedicated to fecal samples) with two semiquantitative tests dedicated to CLP determination: (1) Actim® Calprotectin (strip) and (2) Accu-Tell® Calprotectin (cassette). The same cut-off values for both tests were possible to determine. Based on the calculated thresholds sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for diagnosing chronic PJI were calculated with statistical methods.</div></div><div><h3>Results</h3><div>For the Actim® Calprotectin (strip), for a positive result (≥+) sensitivity was 97.4 % (95 %CI=86.2–99.9), specificity was 81.7 % (95 %CI=69.6–99.9), PPV was 77 % (95 %CI=66.3–85.2) and NPV was 98 % (95 %CI=87.6-99.7). For the Accu-Tell® Calprotectin (cassette) test, for a positive result, (≥+) sensitivity, specificity, PPV, and NPV were 89.5 % (95 %CI=75.2–97.1), 90 % (95 %CI=79.5-96.2), 85 % (95 %CI=72.5–92.4), and 93.1 % (95 %CI=84.2–97.2), respectively.</div></div><div><h3>Conclusion</h3><div>Both POC CLP tests have very good accuracy with off-label use on synovial fluid samples. After validation and adaptation these tests for liquid samples (synovial fluid), we believe these tests may be valuable support in routine clinical practice, especially in POC conditions.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116942"},"PeriodicalIF":2.1,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144263478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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","authors":"Jurema Guerrieri Brandão ,&nbsp;Alexandre Casimiro de Macedo ,&nbsp;George Jó Bezerra Sousa ,&nbsp;Patrícia Pereira Lima Barbosa ,&nbsp;Patrícia Estrela Evangelista ,&nbsp;Thiago Brobio Massanti ,&nbsp;Ciro Martins Gomes","doi":"10.1016/j.diagmicrobio.2025.116929","DOIUrl":"10.1016/j.diagmicrobio.2025.116929","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"113 2","pages":"Article 116929"},"PeriodicalIF":2.1,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144314030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}