Diagnostic microbiology and infectious disease最新文献

{"title":"Evaluation of a Multiplex Bead Assay for Strongyloides stercoralis diagnosis using the recombinant antigen rSs-NIE-1","authors":"Joelma Nascimento de Souza,&nbsp;Wéslei Almeida Costa Araújo,&nbsp;Márcia Cristina Aquino Teixeira,&nbsp;Neci Matos Soares","doi":"10.1016/j.diagmicrobio.2025.117108","DOIUrl":"10.1016/j.diagmicrobio.2025.117108","url":null,"abstract":"<div><div><em>Strongyloides stercoralis</em> diagnosis is still a challenge to public health. Multiplex assays offer the advantage of testing several parameters simultaneously, which could allow the detection of several parasitic infections at the same time. This study aimed to evaluate the sensitivity and specificity of a Multiplex Bead Assay (MBA) in MagPix® platform for <em>S. stercoralis</em> diagnosis using a recombinant antigen to detect different isotypes of specific antibodies. This study enrolled 330 alcoholic male inpatients. Parasitological examination was performed on three fecal samples. Sera samples were tested with MBA for IgG, IgG1, IgG4, IgA1 and IgE antibodies against <em>S. stercoralis</em> recombinant antigen rSs-NIE-1, and for IgG antibody against recombinant antigens of <em>Toxocara canis</em> excretory–secretory antigen (Tc-CTL-1) and microsomal fraction of <em>Schistosoma mansoni</em> adult worms (MAMA). The MBA did not present reactions for IgA1 or IgE detection. The highest sensitivity was observed in NIE-IgG (95.7 %), while the highest specificity was demonstrated in NIE-IgG1(92.3 %). However, based on the likelihood ratio (LR), the best diagnostic test was NIE-IgG4 (LR 9.96). Possible cross-reactions were observed in all antibody isotypes tested, mainly for NIE-IgG. This study demonstrates that MBA can be used as an alternative diagnostic tool for <em>S. stercoralis</em> infection, particularly in the detection of IgG4-specific antibodies.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"114 2","pages":"Article 117108"},"PeriodicalIF":1.8,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145102631","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":"\"Is the Ceftazidime-avibactam plus aztreonam combination a solution for infections caused by metallo-β-lactamase producing carbapenem-resistant Enterobacterales? A call for further investigation\"","authors":"Neha Sunil Bawankar ,&nbsp;Samrin Ejaz Hussain Sayed ,&nbsp;Swati M. Bhise ,&nbsp;Rajni Gaind","doi":"10.1016/j.diagmicrobio.2025.117107","DOIUrl":"10.1016/j.diagmicrobio.2025.117107","url":null,"abstract":"<div><h3>Purpose</h3><div>There are limited therapeutic options for carbapenem-resistant Enterobacterales (CRE). Ceftazidime-avibactam (CZA) is ineffective against metallo-β-lactamases (MBLs) like New Delhi metallo-β-lactamase (NDM). The synergistic combination of CZA and aztreonam (ATM) is a potentially useful option. This study evaluates the in-vitro efficacy and synergy of CZA-ATM against NDM CRE and proposes a practical and reliable screening test for CZA-ATM synergy.</div></div><div><h3>Material and Methods</h3><div>A total of 60 MBL-CRE were characterized for carbapenemases and in-vitro synergy of CZA-ATM using the gradient E-test strip (ESM) and the disc replacement method (DRM). CLSI breakpoints for ATM (MIC ≤4 µg/mL or zone diameter ≥21 mm) were used to define susceptibility for isolates showing CZA-ATM synergy.</div></div><div><h3>Results</h3><div>Among 60 CRE, <em>bla</em>_NDM was detected in 53 isolates (88.3%). CZA-ATM synergy was detected in 40/53 (75.5%) NDM-CRE using the ESM and in 38/53 (71.7%) by DRM. Among the 7 non-NDM CRE, 4 (57.1%) showed synergy by both methods. Among 11/60 (18.3%) isolates, the MICs of ATM were &gt;4 µg/mL when tested in combination with CZA. DRM showed excellent concordance with E-test with a sensitivity of 95.5%, specificity of 100%, and an agreement rate of 96.7% (κ = 0.96).</div></div><div><h3>Conclusion</h3><div>The CZA-ATM combination shows promising in-vitro synergy against 75.5% <em>bla</em>_NDM-producing CRE. As significant number of isolates (18.3%) demonstrated ATM MIC ≥4 μg/mL when tested in combination with CZA, in-vitro testing should be performed to guide its clinical use. The DRM can be used as a reliable, cost-effective synergy test that can be easily incorporated in laboratory workflow.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"114 2","pages":"Article 117107"},"PeriodicalIF":1.8,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112189","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":"Clinical evaluation of the NovaplexTM Dermatophyte qPCR assay for the detection of dermatophyte fungi and Candida albicans in skin and nail material","authors":"Lucía Argente-Colás ,&nbsp;Leire Beramendi ,&nbsp;Nekane Maidagan ,&nbsp;Julio-Alberto Cuevas-Alcón ,&nbsp;Ana Navascués-Ortega ,&nbsp;Carmen Ezpeleta-Baquedano ,&nbsp;María-Eugenia Portillo ,&nbsp;Miguel Fernández-Huerta","doi":"10.1016/j.diagmicrobio.2025.117109","DOIUrl":"10.1016/j.diagmicrobio.2025.117109","url":null,"abstract":"<div><div>Cutaneous fungal infections are usually caused by dermatophytes, but also yeasts and other non-dermatophyte molds. The microbiological diagnosis of these mycoses traditionally relies on direct microscopic examination (DME) and culture. However, these procedures hold important limitations. Recently, some marketed qPCR methods have emerged for the identification of both dermatophyte and non-dermatophyte fungi. Herein, we aim to perform a head-to-head evaluation of the clinical performance of the Novaplex^TM Dermatophyte RUO qPCR assay (Seegene) in comparison to the EurobioPlex Dermatophytes CE-IVD-branded qPCR assay (Eurobio Scientific) for the detection of dermatophyte fungi in skin and nail material.</div><div>Between February and July 2024, 998 samples (735 were nail material and 263 corresponded to skin specimens) from 945 patients were collected for the molecular investigation of dermatophyte fungi at the Navarra University Hospital in Pamplona, Spain. DNA extraction was performed following Seegene instructions, and both qPCR methods were subsequently executed. In case of discrepancies, the Dermato<strong><em>Plex</em></strong> qPCR assay (SpeeDx) was used, along with DME and culture results in some cases.</div><div>Overall, the Novaplex^TM Dermatophyte assay performed well for the molecular detection of dermatophyte fungi and <em>Candida albicans</em> in samples of skin and nails; with an overall agreement of 94.1 % when compared with the EurobioPlex Dermatophytes assay. Ignoring <em>Microsporum</em> spp. cases, only 59/998 (5.9 %) discrepancies were detected. Of them, most (62.7 %) evaluated the Novaplex^TM Dermatophyte assay positively. Acknowledging the increased sensitivity of molecular methods compared to conventional procedures, the Novaplex^TM Dermatophyte assay is a reliable qPCR method for diagnosis of cutaneous mycoses.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"114 2","pages":"Article 117109"},"PeriodicalIF":1.8,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112146","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 impact of geography and antimicrobial resistance on the incidence and outcomes of Elizabethkingia species bloodstream infection","authors":"Adam G Stewart ,&nbsp;Felicity Edwards ,&nbsp;Kevin B Laupland","doi":"10.1016/j.diagmicrobio.2025.117106","DOIUrl":"10.1016/j.diagmicrobio.2025.117106","url":null,"abstract":"<div><div>We conducted a 20-year statewide cohort of 115 <em>Elizabethkingia</em> bloodstream infections in Queensland, Australia. Incidence was ∼9-fold higher in tropical vs temperate regions, with 61 % community-onset. Ciprofloxacin susceptibility was 74.8 %. Thirty-day mortality was 14.9 %, and ciprofloxacin resistance independently predicted death, though interpretation is limited without treatment data.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"114 1","pages":"Article 117106"},"PeriodicalIF":1.8,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145045292","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":"Evaluation of PNPLA3 genetic variants in Egyptian HBV-infected patients concomitant with metabolic-associated steatotic liver disease (MASLD)","authors":"Mai Abd El-Meguid ,&nbsp;Ghada M. Salum ,&nbsp;Basma E. Fotouh ,&nbsp;Naglaa Zayed ,&nbsp;Shereen Abdel Alem ,&nbsp;Ayman Yosry ,&nbsp;Reham M. Dawood","doi":"10.1016/j.diagmicrobio.2025.117105","DOIUrl":"10.1016/j.diagmicrobio.2025.117105","url":null,"abstract":"<div><div>Hepatitis B virus (HBV) infection and metabolic-associated steatotic liver disease (MASLD) increasingly coexist, creating complex diagnostic and therapeutic challenges. This study examined the association between the <em>PNPLA3</em> rs738409 genetic variants and the progression of hepatic steatosis and fibrosis in HBV patients who have and do not have MASLD. A total of 170 Egyptian HBV patients were enrolled and categorized into two groups: non-MASLD (<em>n</em>=99) and MASLD (<em>n</em>=71). The assessment of liver stiffness and hepatic steatosis was conducted using transient elastography (FibroScan®) and controlled attenuation parameter (CAP). Genotyping for <em>PNPLA3</em> was performed via real-time PCR. The <em>PNPLA3</em> GG genotype and G allele were significantly linked to the progression of hepatic steatosis in HBV-MASLD patients. Moreover, the frequency of CG+GG genotypes was higher in HBV-MASLD patients during both early (53.1% vs. 34.2%, <em>p</em>=0.035) and late fibrosis stages (73.7% vs. 33.3%, <em>p</em>=0.014) compared to non-MASLD patients. No association was found between <em>PNPLA3</em> genotypes and HBV DNA levels. HBV viral load was notably associated with different fibrosis stages but was not linked to steatosis. HBV patients carrying the <em>PNPLA3</em> GG genotype or G allele are more susceptible to developing MASLD and severe steatosis. Additionally, <em>PNPLA3</em> variants may be implicated in the progression of fibrosis within the context of metabolic dysfunction; this association is not apparent in non-MASLD cases. Furthermore, viral dynamics appear to influence the progression of hepatic fibrosis but not steatosis. The concomitant MASLD in HBV patients was not associated with the severity of hepatic fibrosis.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"114 2","pages":"Article 117105"},"PeriodicalIF":1.8,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112174","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 emerging clinical relevance of enterococcus gallinarum: A roadmap for future research and diagnostics","authors":"Zeeshan Hyderi,&nbsp;Kiruthika Saravanan ,&nbsp;Deepa Iswarya M․S ,&nbsp;Arumugam Veera Ravi","doi":"10.1016/j.diagmicrobio.2025.117104","DOIUrl":"10.1016/j.diagmicrobio.2025.117104","url":null,"abstract":"<div><div><em>Enterococcus gallinarum</em> is an underdiagnosed yet clinically significant opportunistic pathogen exhibiting growing concerns in antimicrobial resistance and pathogenicity. Initially regarded as a commensal of the gastrointestinal tract, <em>E. gallinarum</em> has emerged as a causative agent of life-threatening infections such as bacteremia, meningitis, endocarditis, and peritonitis, particularly in immunocompromised individuals. A key factor in the pathogenicity of <em>E. gallinarum</em> is its ability to form biofilms, a mechanism that enhances its resistance to antibiotics (vancomycin resistance) and host immune responses. The bacterium’s genetic adaptability, efflux pumps, and enzyme-mediated resistance further complicate treatment regimens, necessitating alternative therapeutic strategies. Given the increasing prevalence of multidrug-resistant enterococci, enhanced surveillance, precise diagnostic techniques, and innovative therapeutic approaches are critical to managing <em>E. gallinarum</em> infections. Transmission via contaminated poultry, seafood, and environmental vectors underscores its zoonotic potential, necessitating stringent food safety protocols. Current therapeutic strategies are failing due to rising resistance limits. Innovative approaches like nanoparticles, bacteriophage therapy, plant-derived compounds and immunomodulatory agents show promise in overcoming resistance and biofilm-related challenges. Artificial Intelligence and computational biology-driven drug discovery offer novel avenues for precision targeting. Diagnostic hurdles, including misidentification and underreporting, highlight the need for advanced molecular techniques and surveillance. Future research should focus on targeted therapies and vaccine development to mitigate the clinical burden of this pathogen. This review delves into the epidemiology, pathogenesis, virulence factors, drug resistance mechanisms and novel treatment modalities of <em>E. gallinarum</em>.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"114 1","pages":"Article 117104"},"PeriodicalIF":1.8,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145045287","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 auxiliary diagnostic performance of creation tuberculin skin test for mycobacterium tuberculosis compared with QuantiFERON-TB Gold Plus: A diagnostic accuracy study","authors":"Jin Yin,&nbsp;Min Yu","doi":"10.1016/j.diagmicrobio.2025.117103","DOIUrl":"10.1016/j.diagmicrobio.2025.117103","url":null,"abstract":"<div><h3>Background</h3><div>For bacteriologically negative suspected tuberculosis, immunological testing provides important diagnostic evidence. The traditional tuberculin skin test has poor specificity. QuantiFERON-TB Gold Plus (QFT-Plus, the latest generation of Interferon-Gamma Release Assays) and creation tuberculin skin test (C-TST) offer higher specificity and are less affected by non-tuberculous mycobacteria and BCG vaccine. However, the efficacy of QFT-Plus and C-TST in suspected tuberculosis remain unclear. We compared the performance of the QFT-Plus with the C-TST in auxiliary diagnosing tuberculosis in individuals with suspected tuberculosis.</div></div><div><h3>Methods</h3><div>The subjects were 137 patients suspected of tuberculosis, including 74 pulmonary tuberculosis (PTB) patients and 63 non-active pulmonary tuberculosis. All participants underwent both QFT-Plus and C-TST testing.</div></div><div><h3>Results</h3><div>The sensitivities of QFT-Plus and C-TST in diagnosing PTB were 93.15 % and 86.49 %, respectively. The specificities of QFT-Plus and C-TST in diagnosing PTB were 40.35 % and 41.27 %, respectively. When QFT-Plus and C-TST were combined, the specificity increased to 58.73 %. The Area Under the Curves of Receiver Operating Characteristic in QFT-Plus and C-TST were 0.79 vs 0.67 (<em>p</em> &lt; 0.05), respectively. In addition, the median IFN-γ level of TB2 tubes in the PTB group of QFT-Plus was significantly higher than that of TB1 tubes.</div></div><div><h3>Conclusions</h3><div>QFT-Plus and C-TST demonstrated diagnostic value in helping clinicians identify PTB and rule out non-patients to a certain extent, and the two methods had moderate agreement. The combined diagnosis statistically improved the specificity in auxiliary diagnosing PTB. Furthermore, the QFT-Plus appears more advantageous than C-TST for auxiliary diagnosing of tuberculosis.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"114 1","pages":"Article 117103"},"PeriodicalIF":1.8,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145045289","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":"Comparison between Xpert ultra and standard M10 for detection of MTBC in clinical samples","authors":"Laura Rindi ,&nbsp;Vincenzo Puglisi ,&nbsp;Iacopo Franconi ,&nbsp;Antonella Lupetti","doi":"10.1016/j.diagmicrobio.2025.117102","DOIUrl":"10.1016/j.diagmicrobio.2025.117102","url":null,"abstract":"<div><div>This study compared the STANDARD M10 MDR-TB with GeneXpert® MTB/RIF Ultra test in detecting tuberculosis on 57 samples. Sensitivity and specificity were 92 % and 100 % with a positive predictive value of 100 % with a substantial agreement (0.74) at Kappa agreement test.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"114 1","pages":"Article 117102"},"PeriodicalIF":1.8,"publicationDate":"2025-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145045291","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":"Evaluation of the semi-quantitative BIOSynex® CryptoPS test in serum and cerebrospinal fluid samples of patients with cryptococcosis diagnosed through the IMMY CrAg® lateral flow assay: a translational study","authors":"Rodrigo Almeida-Paes ,&nbsp;Marcos Abreu Almeida ,&nbsp;Marcela de Faria Ferreira ,&nbsp;Andrea dAvila Freitas ,&nbsp;Rosely Maria Zancopé-Oliveira","doi":"10.1016/j.diagmicrobio.2025.117096","DOIUrl":"10.1016/j.diagmicrobio.2025.117096","url":null,"abstract":"<div><div>The advent of lateral flow assays (LFAs) has significantly improved the diagnosis of cryptococcosis. While the widely used IMMY CrAg® LFA is qualitative, antigen titration requires multiple test strips, increasing cost and complexity. The BIOSynex® CryptoPS is a semi-quantitative LFA that categorizes antigen levels into two ranges, low (≤25 ng/ml in cerebrospinal fluid [CSF] or ≤50 ng/ml in serum) and high (≤2,500 ng/ml in both sample types). We evaluated the performance and prognostic relevance of this assay in 22 serum and 14 CSF samples from 23 patients with cryptococcosis. Seventeen patients had culture confirmed cryptococcosis, while six were diagnosed by isolated antigenemia using the IMMY CrAg® LFA. Three samples tested negative by BIOSynex® CryptoPS despite being positive by IMMY CrAg® LFA. Among culture positive patients, all showed high antigen levels in the BIOSynex® CryptoPS. Higher antigen levels were significantly associated with lower CD4 counts in people living with HIV/AIDS (<em>P</em> = 0.026) and more frequent cryptococcal meningitis (<em>P</em> = 0.040), though not fungemia (<em>P</em> = 0.144). Two deaths occurred in patients with high antigen levels. The BIOSynex® CryptoPS LFA demonstrated good agreement with IMMY CrAg® LFA and provided prognostic insights, highlighting its potential role in clinical risk stratification and early management of cryptococcosis.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"114 1","pages":"Article 117096"},"PeriodicalIF":1.8,"publicationDate":"2025-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145045288","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":"Diagnostic tests for Nipah virus: A landscape analysis","authors":"Laura Mazzola ,&nbsp;Hanesh Chi Fru ,&nbsp;Dounia Cherkaoui ,&nbsp;Sophie Crettaz ,&nbsp;Nsonghomanyi Fritz Roland Fonkeng ,&nbsp;Audrey Albertini ,&nbsp;Devy M. Emperador ,&nbsp;Kavi Ramjeet ,&nbsp;Emmanuel Agogo","doi":"10.1016/j.diagmicrobio.2025.117101","DOIUrl":"10.1016/j.diagmicrobio.2025.117101","url":null,"abstract":"<div><div>Introduction: Nipah virus (NiV) is an emerging human pathogen with a high case fatality rate. The World Health Organization research and development roadmap for NiV published in 2019 highlighted a lack of validated and regulated Nipah virus (NiV) diagnostic tests, particularly those that can be used at the point of care (POC). This analysis assessed the current landscape of NiV diagnostics, including commercial tests and tests in development, to determine whether these gaps remain.</div><div>Methods: Commercial tests for NiV diagnosis were identified through searches of diagnostic databases and news platforms, targeted internet queries, and email exchanges with manufacturers. Non-commercial tests were identified through a literature search. Molecular tests, immunoassays and supportive protocols such as field-appropriate sample inactivation were included.</div><div>Results: We identified 43 commercial NiV tests. Only six tests had national regulatory approval. Three molecular tests were designed for near POC and one lateral flow assay for true POC testing. Twenty-eight publications were identified by the literature search, of which 23 described test development and/or validation, three were independent evaluations or external quality assurance studies, and two were NiV inactivation protocols. Nine publications reported novel POC prototype development, of which seven were molecular assays, one an antigen test, and one a ribozyme biosensor. Clinical performance data on these prototypes were limited.</div><div>Conclusions: Few commercial tests for NiV are available, especially POC tests suitable for use in remote settings where the virus is endemic. To address this gap, further evaluation and validation of tests in development with POC potential is required.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"114 1","pages":"Article 117101"},"PeriodicalIF":1.8,"publicationDate":"2025-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145045386","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}