Journal of Clinical Microbiology最新文献

{"title":"Performance of liquid Amies transport medium for the recovery of <i>Salmonella</i> and <i>Shigella</i> from stool compared to molecular testing.","authors":"Laura Collier, Morgan A Pence","doi":"10.1128/jcm.00453-25","DOIUrl":"10.1128/jcm.00453-25","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0045325"},"PeriodicalIF":6.1,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12239730/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mismatch-corrected CHIKV CDC Trioplex assay oligos restore sensitive pangenotype viral detection.","authors":"Lika Aminata Diouf, Mignane Ndiaye, Diamilatou Balde, Agathe Shella Efire, Moussa Dia, Fatou Thiam, Manfred Weidmann, Oumar Faye, Idrissa Dieng","doi":"10.1128/jcm.00490-25","DOIUrl":"10.1128/jcm.00490-25","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0049025"},"PeriodicalIF":6.1,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12239721/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144266387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of <i>Mucorales</i> antigen in bronchoalveolar lavage samples using a newly developed lateral-flow device.","authors":"Julie Rousselot, Laurence Millon, Emeline Scherer, Nathalie Bourgeois, Sebastien Imbert, Damien Dupont, Anne Debourgogne, Danièle Maubon, Anne Pauline Bellanger, Christopher R Thornton","doi":"10.1128/jcm.00226-25","DOIUrl":"10.1128/jcm.00226-25","url":null,"abstract":"<p><p>A murine IgG2b monoclonal antibody, named TG11, binding to an extracellular polysaccharide antigen secreted by all <i>Mucorales</i> fungi has been recently developed and integrated into a lateral-flow device (TG11-LFD). The aim of this study was to establish the clinical performance of TG11-LFD on bronchoalveolar lavage (BAL) fluids for the diagnosis of mucormycosis. Thirteen BAL samples from 13 patients with mucormycosis, all of which tested positive for <i>Mucorales</i> qPCR (<i>Mucor/Rhizopus</i> [<i>n</i> = 5], <i>Lichtheimia</i> [<i>n</i> = 2], <i>Rhizomucor</i> [<i>n</i> = 5], and <i>Cunninghamella</i> [<i>n</i> = 1]), were used to assess the TG11-LFD. We also selected 49 BAL samples from 25 patients with other invasive fungal infections (IFI) (aspergillosis, <i>Pneumocystis</i> infection, candidiasis, and possible IFI) and from 20 patients without IFI for use as negative controls. The intensities of the test and control lines were recorded using a Cube reader. The diagnostic performance was assessed by analyzing the receiver operating characteristics (ROC) curve with the Jamovi software package (version 2.6.13). The area under the curve of the ROC curve was 0.739. Using a threshold value positivity ≤531 artificial units, the TG11-LFD test has a sensitivity and specificity of 76.92% and 75.51%, respectively, a positive predictive value of 45.45%, and a negative predictive value of 92.5%. In this study, we evaluated the performance of TG11-LFD on clinical samples for the first time and demonstrated its significant potential for enhancing the rapid detection of mucormycosis. Combining antigen detection with qPCR, as successfully applied in the diagnosis of aspergillosis, is likely to yield the most reliable diagnostic approach.IMPORTANCEMucormycosis is a severe emerging, invasive fungal disease caused by fungi in the order <i>Mucorales</i>. The mortality rate remains high at approximately 50%. Rapid diagnosis and prompt initiation of targeted treatment are associated with an improved prognosis. Gold standard diagnostic procedures have poor sensitivity and long turnaround times. <i>Mucorales</i> polymerase chain reaction in blood and respiratory samples has improved diagnosis, but this technique is not widely available due to high costs and the need for specialist equipment. A prototype lateral-flow device (TG11-LFD) incorporating a mouse monoclonal antibody, which binds to an extracellular polysaccharide antigen specific to <i>Mucorales</i> fungi, has been recently developed. In this study, we evaluated for the first time the performance of the TG11-LFD test on clinical bronchoalveolar lavage fluids for diagnosing mucormycosis. With 76.92% sensitivity and 75.51% specificity, this innovative, simple, and affordable approach shows great potential for improving the rapid diagnosis of mucormycosis.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0022625"},"PeriodicalIF":6.1,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12239717/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144325905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative performance of cobas 4800 HPV Test and Anyplex II HPV HR for high-risk human papillomavirus detection.","authors":"Luani R Godoy, Mariam El-Zein, Elizaveta Padalko, Bo Verberckmoes, Bodine Van Eenooghe, Heleen Vermandere, Sónia Dias, Ana Gama, Bernardo Vega Crespo, Vivian Alejandra Neira, Eduardo L Franco, Adhemar Longatto-Filho","doi":"10.1128/jcm.00200-25","DOIUrl":"https://doi.org/10.1128/jcm.00200-25","url":null,"abstract":"<p><p>Numerous molecular tests are available to detect human papillomavirus (HPV). We compared the analytical performance of cobas and Anyplex for detection of high-risk (HR) carcinogenic HPV genotypes, assessed the composition of HPV types (other than 16 and 18) that influenced cobas performance, and considered the impact of viral load on test performance. We used data from the Early Detection of Cervical Cancer in Hard-to-Reach Populations of Women Through Portable and Point-of-Care HPV Testing project, which involved collection (2019-2022) of cervicovaginal samples from 1,042 women aged 21-74 years in Belgium (<i>n</i> = 244), Portugal (<i>n</i> = 309), Brazil (<i>n</i> = 244), and Ecuador (<i>n</i> = 245). Samples were tested by cobas (provides individual results for HPV16 and HPV18 and a pooled result for 12 other HR-HPV types) and Anyplex (provides separate results for 14 HR-HPVs). We calculated HPV positivity by each test and compared performance between tests by calculating Cohen's kappa statistics. Based on 938 samples with complete data from both tests, positivity rates by cobas were 13.4%, 3.6%, 34.3%, and 45.3% for HPV16, HPV18, 12 pooled HR-HPVs, and any HR-HPV, respectively. Corresponding HPV positivity rates by Anyplex were 14.9%, 3.7%, 37.9%, and 50.0% for the same categories, respectively, with high concordance; kappa statistics were 0.90, 0.87, 0.82, and 0.85, respectively. Based on 355 samples that tested positive for at least 1 of the 12 pooled HR-HPVs, most types showed high agreement (80.9%-100.0%) between individual-Anyplex and pooled-cobas HPV results, except for HPV68 (61.3% agreement). Our findings suggest that the two commercial tests may have different performances, depending on the specific HPV types detected, emphasizing the need for continued research on conditions that may affect these tests, especially for less common or less studied HPV types.IMPORTANCEThis study compared two commercial tests-cobas and Anyplex-for detecting high-risk HPV types in women undergoing routine cervical cancer screening or referred for colposcopy. Both tests provide separate results for HPV16 and HPV18, but Anyplex also identifies the remaining 12 high-risk HPV types individually, while cobas groups them together. Overall, we found a high level of agreement between the two tests, supporting their use in clinical practice. However, differences in detecting certain HPV types, particularly those that are less common or less studied, emphasize the importance of choosing the right test. As more countries switch to HPV-based cervical cancer screening, using tests that provide detailed results could help improve risk assessment and optimize patient care.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0020025"},"PeriodicalIF":6.1,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144591365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Automated identification of <i>Salmonella</i> serotype using MALDI-TOF mass spectrometry and machine learning techniques.","authors":"Jun Ren, Jintao Xia, Mengyu Zhang, Chunhong Liu, Yuanyuan Xu, Jianing Wu, Yingzhu Li, Mingming Zhou, Shengjie Li, Wenjun Cao","doi":"10.1128/jcm.00037-25","DOIUrl":"10.1128/jcm.00037-25","url":null,"abstract":"<p><p><i>Salmonella</i> serotyping is essential for epidemiological studies and clinical treatment guidance. However, traditional serological agglutination methods are time-consuming, technically complex, and difficult to adopt at scale. Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) is a rapid and cost-effective microbial identification technique, but it cannot be used to differentiate <i>Salmonella</i> serotypes. This study aims to integrate MALDI-TOF MS with machine learning algorithms to develop and validate a model for <i>Salmonella</i> serotype identification, improving efficiency and simplifying workflows. A total of 692 <i>Salmonella</i> isolates from Children's Hospital, Zhejiang University School of Medicine (ZUCH) and Wanbei Coal-Electricity Group General Hospital (WCGH) were analyzed using MALDI-TOF MS, generating 2,048 spectra. The ZUCH data were randomly divided into training and internal validation sets. The WCGH data were used as an external validation set. Ten machine learning algorithms were evaluated for their ability to identify eight <i>Salmonella</i> serotypes (B, C1, C2/3, D, E, Not A-F, <i>Salmonella</i> Typhimurium, and <i>Salmonella</i> Enteritidis). From 192 initial features, 16 features were selected for the final model construction. XGBoost demonstrated the best discriminative ability (area under the receiver operating characteristic curve [AUC] = 0.9898, sensitivity = 0.88, and specificity = 0.98) for the training set. The streamlined XGBoost model achieved AUCs of 0.9662 and 0.9778 for the internal and external validation sets, respectively, accurately identifying <i>Salmonella</i> serotypes. To enhance usability, the model was deployed as a Streamlit-based application, facilitating interaction and broader application. MALDI-TOF MS combined with XGBoost provides a fast and accurate method for <i>Salmonella</i> serotype identification, offering an efficient solution for laboratory diagnostics and epidemiological studies.</p><p><strong>Importance: </strong><i>Salmonella</i> serotyping is vital for outbreak tracking and clinical guidance, but traditional methods are slow and laborious. This study combines matrix-assisted laser desorption ionization-time of flight mass spectrometry with machine learning (XGBoost) to enable rapid, accurate, and cost-effective serotyping. The streamlined model performed excellently in validation and was deployed as a user-friendly Streamlit app, enhancing usability. This innovation simplifies workflows, reduces diagnostic time, and supports scalable use in clinical and public health settings, improving outbreak response and epidemiological research.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0003725"},"PeriodicalIF":6.1,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12239726/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144266386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction for Weyand et al., \"Fatal interactions: pneumonia in bighorn lambs following experimental exposure to carriers of <i>Mycoplasma ovipneumoniae</i>\".","authors":"Logan K Weyand, Brandi L Felts, E Frances Cassirer, Jonathan A Jenks, Daniel P Walsh, Thomas E Besser","doi":"10.1128/jcm.00426-25","DOIUrl":"10.1128/jcm.00426-25","url":null,"abstract":"","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0042625"},"PeriodicalIF":6.1,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12239714/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144258125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Point-Counterpoint: Cascade reporting-useful tool to support antimicrobial stewardship, or dangerously misleading.","authors":"Joseph L Kuti, Joseph D Lutgring, Patricia J Simner, Samia N Naccache, Emily L Heil","doi":"10.1128/jcm.01708-24","DOIUrl":"10.1128/jcm.01708-24","url":null,"abstract":"<p><p>Addressing antimicrobial resistance requires multi-disciplinary action, including from the clinical laboratory. Cascade reporting of the antimicrobial susceptibility test (AST) is a strategy used by some laboratories to nudge clinicians toward the use of more narrow-spectrum antimicrobials. Cascade reporting involves suppression of broader-spectrum antimicrobials if the narrower-spectrum first-line antimicrobials show in-vitro susceptibility. Studies have shown that cascade reporting can reduce use of broad-spectrum antimicrobials and reduce antimicrobial resistance rates. However, implementing cascade reporting can be complex, and some question the effectiveness on impacting long-term prescribing behaviors. Furthermore, there are concerns surrounding compliance and the possible negative impact on public health surveillance for antimicrobial resistance. In this article, experts weigh in on the benefits and risks associated with implementing AST cascade reporting. General consensus is that cascade reporting is a benefit to antimicrobial stewardship, but protocols need careful implementation to minimize risk to patients and public health.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0170824"},"PeriodicalIF":6.1,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144317049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inter-laboratory variability in cytomegalovirus DNA quantification: implications for standardization and clinical monitoring.","authors":"D Boutolleau, A-S L'Honneur, R Germi, B Chanzy, C Archimbaud-Jallat, C Rzadkowolski, J B Raimbourg, D Gauthier, V Thibault","doi":"10.1128/jcm.01911-24","DOIUrl":"10.1128/jcm.01911-24","url":null,"abstract":"<p><p>Cytomegalovirus (CMV) infection monitoring is a key element in the management of immunocompromised patients. CMV DNA quantification in plasma or whole blood is the best indicator for clinicians to adjust immunosuppressive or antiviral therapies. Despite the availability of internationally standardized material, the commutability of CMV quantification results across laboratories remains inadequate. To assess inter-laboratory variability in CMV DNA quantification, we conducted a blinded study in seven independent laboratories. Each participant received a panel of 92 specimens for CMV quantification using their routinely used standard platform. While quantifications were highly correlated and reproducible, large discrepancies were observed with differences up to 1.45 log₁₀ IU/mL between techniques for identical specimens. However, quantification scattering was lower for the World Health Organization (WHO) international standard or a commercially tested control (interquartile range = 0.129) than for clinical specimens (0.469; <i>P</i> = 0.0142). Blind quantification of the WHO or the commercial standard indicated that all techniques, except for fully integrated platforms, did not align well with the expected values, and most platforms tended to quantify specimens and standards differently. Recalibration of all platforms against the same standard improved the spread of results, but differences of up to 1.19 log₁₀ IU/mL remained for the same specimens. Achieving commutability in CMV quantification remains an elusive goal. Efforts should focus on improving both the assay calibrators and the run controls, which currently do not appear to simulate the unique characteristics of circulating CMV in patients. Until this is resolved, each transplanted patient should be consistently monitored by the same laboratory on the same platform.IMPORTANCEOur conclusions support previous work on this topic describing the diversity of circulating cytomegalovirus (CMV) DNA forms and the difficulties in standardizing CMV viral load (VL) measurement. The inter-assay reproducibility of CMV VL measurement is primarily influenced by the extraction procedure and the amplicon size generated by the technique. Viral standards generated from cell culture supernatant do not reflect circulating CMV forms from patient samples. We highlight the need to develop a new international standard that better reflects the circulating forms of CMV and demonstrate the risk of tracking a patient's CMV VL in different laboratories.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0191124"},"PeriodicalIF":6.1,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12239724/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144225624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identification and quantification of <i>gyrA</i> variants in fluoroquinolone-resistant <i>Mycobacterium tuberculosis</i> in a MeltArray reaction.","authors":"Chunxia Tu, Biyi Su, Yunfan Xiong, Zihan Xia, Chunlin Xiang, Yaoju Tan, Ye Xu, Qingge Li","doi":"10.1128/jcm.00146-25","DOIUrl":"10.1128/jcm.00146-25","url":null,"abstract":"<p><p>Fluoroquinolones (FQs) resistance in <i>Mycobacterium tuberculosis</i> (MTB), primarily driven by mutations in the quinolone resistance-determining region (QRDR) of <i>gyrA</i>, poses a major concern in treating for multidrug-resistant tuberculosis (MDR-TB). These QRDR mutations are known to confer varying levels of resistance, leading to differences in treatment outcomes. Here, we introduced the MeltArray MTB/FQs assay, a multiplex PCR method that detected 11 <i>gyrA</i>-QRDR mutations and quantified their fractions via a polynomial regression algorithm-based formula, enabling mutation identification and quantification within 3 h in one reaction. This assay, with a limit of detection (LOD) of 50 copies/reaction, could identify mixtures containing 5% mutant gDNA across 50 to 50,000 copies/reaction. Clinical evaluation of 442 culture samples displayed 95.23% sensitivity and 99.32% specificity compared with phenotypic antimicrobial susceptibility testing (pAST). Evaluation of 121 paired sputum-culture samples revealed sensitivities of 90.32% in sputum samples and 95.24% in culture samples, both with specificities of 100%, when compared with pAST. Further evaluation of 285 sputum samples showed 93.75% positive percent agreement (PPA) and 98.10% negative percent agreement (NPA) in comparison with the MeltPro MTB/FQs kit (Zeesan Biotech, China). All mutant samples identified by MeltArray MTB/FQs but classified as susceptible by pAST or as wild type by MeltPro MTB/FQs were confirmed through Sanger sequencing and droplet digital PCR (ddPCR). The formula for predicting mutation fraction (MUT%) showed accuracy rates of 88.00%, 88.89%, and 83.33% in the training, validation, and test data sets, respectively, when compared with ddPCR results. Overall, MeltArray MTB/FQs assay offers an upgraded alternative for routine FQs resistance monitoring.IMPORTANCERising FQs resistance has driven the spread of pre-extensively drug-resistant tuberculosis (pre-XDR-TB), challenging global tuberculosis (TB) control efforts. Conventional molecular assays for FQs resistance often cannot distinguish between low-level and high-level resistance mutations or detect low-fraction heteroresistant populations. In this study, we established a MeltArray MTB/FQs assay that can identify all the 11 critical mutations in the <i>gyrA</i>-QRDR with a LOD of 50 copies/reaction, enabling direct, culture-independent analysis of sputum samples. By using an algorithm to quantify mutations at levels as low as 5% in mixtures, MeltArray achieved both mutation identification and quantification within 3 h in a reaction, thus providing a powerful tool for early detection and precise management of pre-XDR-TB.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0014625"},"PeriodicalIF":6.1,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12239727/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144208680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improved HIV-1 RNA detection using whole blood versus plasma in antiretroviral-treated individuals.","authors":"Vivian I Avelino-Silva, Mars Stone, Leilani Montalvo, Clara Di Germanio, Sonia Bakkour, Marion C Lanteri, Eduard Grebe, Brian Custer, Xutao Deng, Renata Buccheri, Karen Harrington, Steven H Kleinman, Sandhya Vasan, Nittaya Phanuphak, Carlo Sacdalan, Siriwat Akapirat, Mark de Souza, Esper G Kallás, Sheila de Oliveira Garcia Mateos, Ester C Sabino, Philip J Norris, Michael P Busch","doi":"10.1128/jcm.01904-24","DOIUrl":"10.1128/jcm.01904-24","url":null,"abstract":"<p><p>Currently, nucleic acid testing (NAT) platforms detect HIV-1 in plasma. Using whole blood (WB) could improve HIV-1 detectability as cellular elements may also contain HIV-1 nucleic acids. We used well-characterized paired WB/plasma panels to evaluate HIV-1 RNA detection inhibition by WB, specificity, and enhanced HIV-1 RNA detectability by WB compared to plasma. Panels included: spiked samples; NAT-/serology-, NAT+/serology+, and NAT-/serology+ blood donor samples; samples from persons with HIV (PWH) who started antiretroviral treatment (ART) at chronic infection stages; and from PWH under ART since acute/early infection. We found one false-positive result on WB testing of 100 NAT-/serology- blood donors, and evidence of modest HIV-1 detection inhibition. Among NAT-/serology+ donors, HIV-1 RNA detectability in plasma and WB was similar (<i>P</i> = 0.64). Among 50 PWH starting ART at chronic infection stages, detectability was 24% in plasma and 92% in WB (<i>P</i> < 0.001). Among 345 PWH on ART since acute/early infection, detectability was 10% in plasma and 16% in WB (<i>P</i> = 0.013). HIV-1 RNA detectability in both plasma and WB was progressively lower for earlier Fiebig stages at ART initiation. WB increased HIV-1 detectability relative to plasma in PWH who initiated ART at all but the earliest infection stages. We failed to find enhanced HIV-1 RNA detectability by WB in NAT-/serology+ blood donors, who may include elite controllers. Enhancing HIV-1 nucleic acid detectability could improve infection ascertainment among PWH on ART with blunted serologic reactivity; investigation of breakthrough infection in PrEP users; and potentially for virus rebound monitoring in HIV-1 cure studies.</p><p><strong>Importance: </strong>Currently, tests to detect HIV genetic materials (RNA/DNA) are done using the liquid component of a blood sample (plasma). However, HIV may be present in blood cellular components, such as white cells and platelets. Here, we investigated if using whole blood (WB; liquid + cellular components) could improve HIV RNA detectability compared to plasma. WB increased HIV RNA detectability in persons with HIV under treatment, including those with early treatment initiation, but not among blood donors with positive HIV serology and undetectable HIV RNA in the donation screening. Enhancing HIV RNA/DNA detectability would support HIV diagnosis in cases with blunted serologic response, such as persons with early antiretroviral treatment initiation or pre-exposure prophylaxis users. It would also be useful for monitoring virus rebound in HIV cure studies and in blood donation screening, where high test sensitivity is required to guarantee the safety of the blood supply.</p>","PeriodicalId":15511,"journal":{"name":"Journal of Clinical Microbiology","volume":" ","pages":"e0190424"},"PeriodicalIF":6.1,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12239725/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}