Lancet MicrobePub Date : 2026-04-01Epub Date: 2025-12-13DOI: 10.1016/j.lanmic.2025.101308
Marcus G Mah , Neha Dikshit , Ramona Alikiiteaga Gutierrez , David Chien Lye , Lin-Fa Wang
{"title":"The threat of another coronavirus pandemic: how are we preparing for it?","authors":"Marcus G Mah , Neha Dikshit , Ramona Alikiiteaga Gutierrez , David Chien Lye , Lin-Fa Wang","doi":"10.1016/j.lanmic.2025.101308","DOIUrl":"10.1016/j.lanmic.2025.101308","url":null,"abstract":"","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"7 4","pages":"Article 101308"},"PeriodicalIF":20.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145769466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lancet MicrobePub Date : 2026-04-01Epub Date: 2026-03-02DOI: 10.1016/j.lanmic.2025.101312
Prof Joshua Wolf MBBS PhD , Kathryn P Goggin MD , Yuki Inaba MS , Kim J Allison BSN , Asim A Ahmed MD , Gabriela Maron MD MS , Jose Ferrolino MD , Lauren Lazure BS , Christina Kohler MS , Abigail Brenner MD , Yilun Sun PhD , Prof Li Tang PhD , Veronica Gonzalez-Pena PhD , Jeffrey E Rubnitz MD PhD , Charles Gawad MD PhD , Elisa B Margolis MD PhD , Prof Paul Thomas PhD
{"title":"Predicting bloodstream infection by plasma cell-free metagenomic sequencing: a prospective cohort study","authors":"Prof Joshua Wolf MBBS PhD , Kathryn P Goggin MD , Yuki Inaba MS , Kim J Allison BSN , Asim A Ahmed MD , Gabriela Maron MD MS , Jose Ferrolino MD , Lauren Lazure BS , Christina Kohler MS , Abigail Brenner MD , Yilun Sun PhD , Prof Li Tang PhD , Veronica Gonzalez-Pena PhD , Jeffrey E Rubnitz MD PhD , Charles Gawad MD PhD , Elisa B Margolis MD PhD , Prof Paul Thomas PhD","doi":"10.1016/j.lanmic.2025.101312","DOIUrl":"10.1016/j.lanmic.2025.101312","url":null,"abstract":"<div><h3>Background</h3><div>Patients receiving myelosuppressive chemotherapy or haematopoietic cell transplantation are at high risk for life-threatening bloodstream infections. A novel pre-emptive treatment paradigm guided by pathogen detection before symptoms appear might reduce this risk, but no validated screening test is available. This study evaluated the sensitivity and specificity of plasma microbial cell-free DNA metagenomic sequencing (mcfDNA-Seq) for predicting bloodstream infections in children and adolescents receiving therapy for high-risk leukaemia.</div></div><div><h3>Methods</h3><div>In this prospective cohort study, between Aug 9, 2017, and Feb 28, 2022, leftover clinical plasma samples were prospectively collected up to once per day from patients who were younger than 25 years, receiving care for leukaemia at St Jude Children’s Research Hospital (Memphis, TN, USA), and at high risk for life-threatening bloodstream infections. mcfDNA-Seq was used to identify pathogen DNA in blood samples obtained during the 7 days before to 1 day after bloodstream infection onset, and in control samples from the same population in the absence of fever or infection. The testing laboratory was masked to sample status. Primary outcomes were predictive sensitivity of mcfDNA-Seq for detecting the expected bloodstream infection pathogen during the 3 days preceding the day of bloodstream infection onset, with a prespecified favourable sensitivity of 50%, and predictive specificity of mcfDNA-Seq in control samples. Exploratory analyses comprised assessing sensitivity and specificity restricted to bacteria or common bloodstream infection pathogens, and after applying a data-derived DNA fragment concentration cutoff; estimating the predictive sensitivity on each of the 7 days before bloodstream infection onset; identifying clinical characteristics that affected predictive sensitivity or specificity; and examining the clinical relevance of additional organisms identified by mcfDNA-Seq during bloodstream infection episodes. Diagnostic sensitivity was also assessed on samples collected on the day of, or day after, diagnosis of bloodstream infection. This study is registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT03226158</span><svg><path></path></svg></span>.</div></div><div><h3>Findings</h3><div>94 evaluable bloodstream infections occurred in 60 (38%) of 158 enrolled participants; 19 episodes were previously described in the pilot phase of this study. The predictive sensitivity of mcfDNA-Seq was 51·9% (95% CI 40·5–63·1) for all bloodstream infection episodes, 53·8% (42·2–65·2) for bacterial infection only, and 51·9% (40·5–63·1) when applying a DNA fragment concentration cutoff of 140 molecules per μL. Sensitivity was lowest at day −7 and increased daily until the day of diagnosis. Diagnostic sensitivity was 81·3% (95% CI 71·0–89·1) for all bloodstream infection episodes and 83·1% (72·9–90·7) for bacterial ","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"7 4","pages":"Article 101312"},"PeriodicalIF":20.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147356767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lancet MicrobePub Date : 2026-04-01Epub Date: 2026-03-10DOI: 10.1016/j.lanmic.2026.101373
Linda S Klavinskis , Edward P Rybicki
{"title":"Report on the 2025 International Society for Vaccines Annual Congress","authors":"Linda S Klavinskis , Edward P Rybicki","doi":"10.1016/j.lanmic.2026.101373","DOIUrl":"10.1016/j.lanmic.2026.101373","url":null,"abstract":"","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"7 4","pages":"Article 101373"},"PeriodicalIF":20.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147460501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lancet MicrobePub Date : 2026-04-01Epub Date: 2025-12-02DOI: 10.1016/j.lanmic.2025.101292
Christoph Buchta MD , Prof Stephan W Aberle MD , Stéphanie Albarède PhD , Xavier Albe PhD , Tony Badrick PhD , Andreas Bietenbeck MD , Vincent Delatour PhD , Gro Gidske PhD , Prof Andrea Griesmacher MD , Prof Jaap J van Hellemond PhD , Gitte M Henriksen MSc , Jim F Huggett PhD , István Juhos PhD , Martin Kammel PhD , Piet Meijer PhD , Prof Ingo Schellenberg Dr rer nat , Prof Heinz Zeichhardt Dr rer nat , Cas Weykamp PhD
{"title":"The concept of external quality assessment super challenges with special consideration of their importance during pandemics","authors":"Christoph Buchta MD , Prof Stephan W Aberle MD , Stéphanie Albarède PhD , Xavier Albe PhD , Tony Badrick PhD , Andreas Bietenbeck MD , Vincent Delatour PhD , Gro Gidske PhD , Prof Andrea Griesmacher MD , Prof Jaap J van Hellemond PhD , Gitte M Henriksen MSc , Jim F Huggett PhD , István Juhos PhD , Martin Kammel PhD , Piet Meijer PhD , Prof Ingo Schellenberg Dr rer nat , Prof Heinz Zeichhardt Dr rer nat , Cas Weykamp PhD","doi":"10.1016/j.lanmic.2025.101292","DOIUrl":"10.1016/j.lanmic.2025.101292","url":null,"abstract":"<div><div>In this Personal View, we introduce the concept of external quality assessment (EQA) super challenges, in which multiple EQA providers, at approximately the same time and in a coordinated manner, use test samples with identical characteristics in their programmes. The evaluation of test results from the resulting increase in the number of laboratories and test systems used (considering the resulting greater variety of influencing factors that apply to the analysis in the individual laboratories) enables the collection of data that reveals differences, advantages, and disadvantages of individual test systems, in addition to the extent of individual influencing factors. By comparing the analytical performance of test systems and highlighting their limitations, EQA super challenges and the examination results collected by them are valuable contributions for post-market surveillance of diagnostic tests, aid harmonisation in laboratory medicine, and help to identify areas for improvement for manufacturers, policy makers, and regulators. Especially during or in preparation for epidemics or pandemics, EQA super challenges are particularly valuable for public health institutions to quickly gain a clear picture of the testing performance.</div></div>","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"7 4","pages":"Article 101292"},"PeriodicalIF":20.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145688472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lancet MicrobePub Date : 2026-04-01Epub Date: 2026-03-03DOI: 10.1016/j.lanmic.2025.101289
Soo Jen Low PhD , Matthew T O’Neill BSc , Janath A Fernando BSc , William J Kerry MBiotech , Jacqueline Prestedge BSc , Natasha Wild BSc , Simran Chahal MA , Georgina L Pollock PhD , Georgina Papadakis BSc , Marcelina Krysiak MSc , Eloise Williams PhD , Francesca Azzato BSc , Thomas Tran BSc , Prof Christopher Fairley PhD , Prof Catriona Bradshaw PhD , Prof Marcus Y Chen PhD , Chuan K Lim PhD , Prof Deborah A Williamson PhD , Shivani Pasricha PhD
{"title":"CRISPR-Cas-based diagnostics for point-of-care detection of sexually transmitted infections: a laboratory development and evaluation study","authors":"Soo Jen Low PhD , Matthew T O’Neill BSc , Janath A Fernando BSc , William J Kerry MBiotech , Jacqueline Prestedge BSc , Natasha Wild BSc , Simran Chahal MA , Georgina L Pollock PhD , Georgina Papadakis BSc , Marcelina Krysiak MSc , Eloise Williams PhD , Francesca Azzato BSc , Thomas Tran BSc , Prof Christopher Fairley PhD , Prof Catriona Bradshaw PhD , Prof Marcus Y Chen PhD , Chuan K Lim PhD , Prof Deborah A Williamson PhD , Shivani Pasricha PhD","doi":"10.1016/j.lanmic.2025.101289","DOIUrl":"10.1016/j.lanmic.2025.101289","url":null,"abstract":"<div><h3>Background</h3><div>Timely, point-of-care diagnosis of sexually transmitted infections (STIs) is crucial for enabling prompt treatment and reducing transmission. We aimed to develop a portable, multiplexed, CRISPR-based assay panel for the detection of <em>Neisseria gonorrhoeae</em> (including the ciprofloxacin resistance marker <em>gyrA</em> S91F), <em>Chlamydia trachomatis</em>, <em>Treponema pallidum</em>, and herpes simplex virus (HSV).</div></div><div><h3>Methods</h3><div>In this laboratory development and evaluation study, we developed and optimised four multiplexed, CRISPR-based, diagnostic STI assays for point-of-care use. The complete assay panel comprised a CRISPR TP–HSV (cTP–HSV) panel for the detection of <em>T pallidum</em> and pan-HSV, with reflex testing to distinguish HSV-1 from HSV-2, and a CRISPR NG–CT (cNG–CT) panel for the detection of <em>N gonorrhoeae</em> and <em>C trachomatis</em>, with reflex testing to detect <em>N gonorrhoeae</em> using two additional genome regions and to identify the <em>gyrA</em> S91F mutation. Each pathogen was targeted at two independent genomic regions by isothermal amplification and CRISPR-Cas reaction using Cas12a and Cas13a, each with distinct fluorescent reporters. Analytical specificity and limits of detection (LODs) were determined, and a retrospective, masked concordance study was conducted on genomic DNA from 900 clinical samples (400 for cTP–HSV and reflex testing and 500 for cNG–CT and reflex testing), using quantitative PCR as the reference standard. The diagnostic accuracy of the test was assessed by analysis of receiver operating characteristic curves.</div></div><div><h3>Findings</h3><div>The overall sensitivity of the TP–HSV CRISPR assay was 82·5% (95% CI 74·0–88·7) for <em>T pallidum</em> and 94·4% (90·2–97·0) for pan-HSV; LODs were 6·2 copies per μL for <em>T pallidum</em> and 7·8 copies per μL for HSV. Reflex testing gave sensitivities of 97·0% (91·1–99·3) for HSV-1 and 96·0% (89·7–98·7) for HSV-2. The NG–CT CRISPR assay had an overall sensitivity of 80·0% (74·0–84·9) for <em>N gonorrhoeae</em> and 73·0% (65·5–79·3) for <em>C trachomatis</em>, with a LOD of 3·9 copies per μL for both pathogens. Reflex testing for the detection of the <em>gyrA</em> S91F mutation in <em>N gonorrhoeae</em> showed an overall sensitivity of 63·1% (55·1–70·4); however, this was dependent on sample type, with a sensitivity of 85·7% (46·7–99·5) in genital samples and 61·2% (52·8–68·9) in extragenital samples. For all pathogens, assay sensitivity was positively correlated with pathogen load. Area under the curve (AUC) values were 0·90 for <em>T pallidum</em> and 0·99 for pan-HSV in the TP–HSV assay, with values of 0·99 for HSV-1 and 0·97 for HSV-2 obtained in the reflex HSV-1–HSV-2 assay. For the cNG–CT assay, AUC values were 0·90 for <em>N gonorrhoeae</em> and 0·85 for <em>C trachomatis</em>, with a value of 0·72 obtained for <em>gyrA</em> S91F in the reflex cNG–gyrA assay.</div></div><div><h3>I","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"7 4","pages":"Article 101289"},"PeriodicalIF":20.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147370203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lancet MicrobePub Date : 2026-04-01Epub Date: 2025-12-16DOI: 10.1016/j.lanmic.2025.101318
Matthew Ho , Jeffrey D Klausner , Lao-Tzu Allan-Blitz
{"title":"Impact of divergent MIC breakpoints on the predictive value of the A311V PBP2 mutation for ceftriaxone resistance in Neisseria gonorrhoeae","authors":"Matthew Ho , Jeffrey D Klausner , Lao-Tzu Allan-Blitz","doi":"10.1016/j.lanmic.2025.101318","DOIUrl":"10.1016/j.lanmic.2025.101318","url":null,"abstract":"","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"7 4","pages":"Article 101318"},"PeriodicalIF":20.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145795116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lancet MicrobePub Date : 2026-04-01Epub Date: 2026-01-19DOI: 10.1016/j.lanmic.2025.101297
Thibaut Vanbaelen , Irith De Baetselier , Achilleas Tsoumanis , Bernadette Hensen , Dorien Van den Bossche , Chris Kenyon
{"title":"Reversing resistance? Declines in macrolide-resistant STIs following antimicrobial stewardship interventions in Belgium","authors":"Thibaut Vanbaelen , Irith De Baetselier , Achilleas Tsoumanis , Bernadette Hensen , Dorien Van den Bossche , Chris Kenyon","doi":"10.1016/j.lanmic.2025.101297","DOIUrl":"10.1016/j.lanmic.2025.101297","url":null,"abstract":"","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"7 4","pages":"Article 101297"},"PeriodicalIF":20.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146031178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lancet MicrobePub Date : 2026-04-01Epub Date: 2026-01-24DOI: 10.1016/j.lanmic.2025.101295
Md Zakiul Hassan MD , Susan Khader Ibrahim MSc , Eli Harriss MSc , Prof Peter Horby PhD , Prof Piero Olliaro PhD , Amanda Rojek PhD
{"title":"Interpreting the natural history and pathogenesis of Nipah virus disease through clinical data, to inform clinical trial design: a systematic review","authors":"Md Zakiul Hassan MD , Susan Khader Ibrahim MSc , Eli Harriss MSc , Prof Peter Horby PhD , Prof Piero Olliaro PhD , Amanda Rojek PhD","doi":"10.1016/j.lanmic.2025.101295","DOIUrl":"10.1016/j.lanmic.2025.101295","url":null,"abstract":"<div><div>Nipah virus is a priority pathogen with high mortality and pandemic potential. Therapies for Nipah virus disease, such as monoclonal antibodies and antivirals, are under development and require clinical trials for evaluation. However, designing such trials is challenging due to the limited understanding of the clinical characteristics, pathogenesis, and current management of Nipah virus disease. In this Review, we gathered essential data from 59 studies reporting 717 Nipah virus disease cases, to inform trial design. Nearly all patients (618 [99%] of 624) had fever. Neurological symptoms included headache (419 [70%] of 601 patients), confusion (74 [65%] of 114), and altered consciousness (358 [62%] of 580); respiratory symptoms included cough (244 [45%] of 541) and difficulty in breathing (184 [58%] of 317). Imaging data revealed chest abnormalities (29 [80%] of 36) and brain involvement (40 [71%] of 56). Viral RNA was detectable early in illness across various sample types. The median case-fatality rate was 69% (IQR 31–88%), with 51 (26%) of 197 survivors presenting with persistent neurological deficits. Clinical management varied widely, with incomplete reporting limiting insights. Prospective observational studies are needed to generate actionable data on clinical case definitions, predictors of adverse outcomes, current standards of care, and standardised endpoints, to inform future trials.</div></div>","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"7 4","pages":"Article 101295"},"PeriodicalIF":20.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146067646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}