Journal of Clinical Virology最新文献

{"title":"Nucleic acid amplification testing using dried blood spots to confirm the diagnosis of HIV-1 in adults","authors":"Benjamin A. Pinsky ,&nbsp;Malaya K. Sahoo ,&nbsp;Justen Manasa ,&nbsp;Tariro Makadzange ,&nbsp;Carole L. Wallis ,&nbsp;Ed G. Marins ,&nbsp;Nagalingeswaran Kumarasamy ,&nbsp;John A. Bartlett ,&nbsp;Ronald J. Bosch ,&nbsp;Dennis Israelski ,&nbsp;David A. Katzenstein ,&nbsp;A5230 and PARC teams","doi":"10.1016/j.jcv.2024.105746","DOIUrl":"10.1016/j.jcv.2024.105746","url":null,"abstract":"<div><h3>Background</h3><div>The WHO HIV testing algorithm for high prevalence populations recommends the use of three different serologic assays, though this approach may lead to diagnostic misclassification. The study objective was to compare dried blood spot (DBS)-based HIV-1 nucleic acid detection methods to determine their suitability to confirm the diagnosis of HIV-1 in adults generally with suppressed or low-level plasma HIV-1 RNA.</div></div><div><h3>Methods</h3><div>Four methods were evaluated: Cepheid Xpert HIV-1 Qual Assay (Xpert), Hologic Aptima HIV-1 Quant Dx assay (Aptima), Roche Cobas Ampliprep/Cobas TaqMan HIV-1 test, v.2.0 (CAP/CTM) with guanidinium-based sample pre-extraction buffer (SPEX), or CAP/CTM with phosphate-buffered saline (PBS). Testing was performed on 163 DBS samples collected from participants with HIV-1 in the AIDS Clinical Trial Group (ACTG) A5230 study (73 samples) and the Peninsula AIDS Research Cohort (PARC) study (90 samples).</div></div><div><h3>Results</h3><div>Xpert and SPEX CAP/CTM [96.9 % (158/163):95.7 % (156/163); <em>P</em> = 0.75) showed similar sensitivity. However, PBS CAP/CTM and Aptima demonstrated significantly lower sensitivity, 68.2 % (107/157) and 69.2 % (99/143), respectively, compared to Xpert and SPEX CAP/CTM (<em>P</em> &lt; 0.0001 for all comparisons). Overall agreement between Xpert and SPEX CAP/CTM was 93.9 % (153/163), including 152 DBS samples in which both methods detected HIV-1 nucleic acids.</div></div><div><h3>Conclusions</h3><div>Xpert and SPEX CAP/CTM provide sensitive performance for the detection of HIV-1 nucleic acids using DBS collected from adults living with HIV-1, including those with suppressed virus loads. Given the cost and side-effects associated with inappropriate life-long antiretroviral therapy, these assays may play a role in diagnosing HIV-1 infection in individuals with suspected false-positive serologic testing.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"175 ","pages":"Article 105746"},"PeriodicalIF":4.0,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142681926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quantification of human immunodeficiency virus type 2 (HIV-2) viral load in plasma: Comparison of three commercial assays","authors":"Iker Falces-Romero ,&nbsp;Isabel García-Pérez ,&nbsp;Luz Martín-Carbonero ,&nbsp;Julio García-Rodríguez ,&nbsp;Jesús Mingorance","doi":"10.1016/j.jcv.2024.105745","DOIUrl":"10.1016/j.jcv.2024.105745","url":null,"abstract":"<div><h3>Introduction</h3><div>There are few validated commercially available HIV-2 assays for the measurement of viral load. Our aim was to compare three commercial assays for the quantification of HIV-2 viral load in plasma of patients with HIV-2 infection from our hospital.</div></div><div><h3>Material and methods</h3><div>We conducted a retrospective study at our tertiary-care hospital, analyzing samples from patients with known HIV-2 infection collected between 2022 and 2023. We compared three commercial assays for quantification of the viral load, Biomérieux® NASBA assay, Thermo Fisher® digital PCR (dPCR) assay and Altona® RT-PCR assay.</div></div><div><h3>Results</h3><div>A total of 27 samples from 11 different patients were included in the study. Sixteen out of them were negative across all three assays. One sample had a low viral load (&lt;2 log copies/mL) detected by the three assays. In five samples a low viral load was only detected by the Altona® assay. The remaining five samples, all from the same patient infected by a multidrug-resistant HIV-2, showed detectable viral load up to 2 log copies/mL by the Thermo Fisher® and Altona® assays, but none of these samples were detected by the Biomérieux® assay.</div></div><div><h3>Conclusions</h3><div>The Altona® RT-PCR assay and the ThermoFisher® dPCR assay could be reliable options as commercial assays for the quantification of HIV-2 RNA in plasma. However, the Biomérieux® NASBA assay, despite detecting both HIV-1 and HIV-2, may have limitations for HIV-2 detection in some cases.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"175 ","pages":"Article 105745"},"PeriodicalIF":4.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142687229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Coinfections and iterative detection of respiratory viruses among 17,689 patients between March 2021 and December 2022 in Southern France","authors":"Cédric Mantelli ,&nbsp;Philippe Colson ,&nbsp;Lucile Lesage ,&nbsp;Didier Stoupan ,&nbsp;Hervé Chaudet ,&nbsp;Aurélie Morand ,&nbsp;Bernard La Scola ,&nbsp;Céline Boschi","doi":"10.1016/j.jcv.2024.105744","DOIUrl":"10.1016/j.jcv.2024.105744","url":null,"abstract":"<div><h3>Objectives</h3><div>We aimed to describe coinfections and iterative infections with respiratory viruses diagnosed over a 22-month period in 2021–2022 in public university hospitals of the second largest French city.</div></div><div><h3>Material and methods</h3><div>Respiratory virus infections were diagnosed by qPCR with the Fast Track Diagnostics Respiratory Pathogens 21 on nasopharyngeal swabs collected between 01/03/2021–31/10/2022 and sent for routine diagnosis purpose to our clinical microbiology-virology laboratory at public university hospitals of Marseille, Southern France.</div></div><div><h3>Results</h3><div>Nasopharyngeal swabs from 17,689 patients were tested, of which 8,133 (46 %) were positive for ≥1 respiratory virus and 1,255 (15%) were co-infected with ≥2 viruses including 213 (2.6 %) with 3–7 viruses. Among them, 1,005 (80 %) were younger than 5 years, and mean age was significantly lower for coinfected than monoinfected patients (6.6 versus 23.8 years; <em>p</em> &lt; 0.0001). Viruses with the highest confection rates were HBoV (97 %), HPeV (97 %), EV (92 %), ADV (68 %), and HCoV-HKU1 (63 %). Iterative infections were observed in 96 patients and they involved 10 different viruses.</div></div><div><h3>Conclusions</h3><div>Our study points out that coinfections with respiratory viruses vary over time in prevalence, involve majoritarily young children, and may involve concurrent acute infections or acute-on-chronic infections, which deserves further specific studies.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"175 ","pages":"Article 105744"},"PeriodicalIF":4.0,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Performance evaluation of the Abbott Alinity Hepatitis C antigen next assay in a US urban emergency department population","authors":"John Prostko ,&nbsp;Richard Rothman ,&nbsp;Yu-Hsiang Hsieh ,&nbsp;Sandra Pearce ,&nbsp;Mark Kilbane ,&nbsp;Karl McAuley ,&nbsp;Edwin Frias ,&nbsp;Russell Taylor ,&nbsp;Hussain Ali ,&nbsp;Carsten Buenning ,&nbsp;Jessica Grieshaber ,&nbsp;Jenna Bedrava ,&nbsp;David Daghfal","doi":"10.1016/j.jcv.2024.105743","DOIUrl":"10.1016/j.jcv.2024.105743","url":null,"abstract":"<div><h3>Introduction</h3><div>HCV antibody assays have been used to screen for HCV, but confirmation of acute infection is dependent on RNA or core antigen testing. The aim of the study was to compare the performance of five HCV test methods, including RNA testing, on a US emergency department population.</div></div><div><h3>Methods</h3><div>Clinical performance metrics were calculated on 708 consenting Johns Hopkins Emergency Department patients who self-reported an increased risk for HCV infection. Detection times of antibody, antigen, and RNA testing were compared using 89 samples from commercially available seroconversion panels. Testing was performed on the Abbott Alinity HCV Ag Next (RUO), Roche Elecsys HCV Duo, Abbott ARCHITECT Anti-HCV, and Elecsys Anti-HCV II assays. RNA testing was performed on the Abbott m2000 system.</div></div><div><h3>Results</h3><div>Overall, 21 (3.0%) participants tested positive for HCV on at least one test, 11 (52.4%) had chronic, 1 (4.8%) had an acute, and 3 (14.3%) had resolved infections. The Alinity HCV Ag Next assay demonstrated 99.43% specificity when compared to RNA testing. The Alinity HCV Ag Next assay also detected 91.67% of the active infections compared to RNA testing, while the Elecsys HCV Duo Ag assay detected only 58.33%. The seroconversion panel testing demonstrated that the Alinity HCV Ag Next assay detects an infection within 0.8 days of an RNA result.</div></div><div><h3>Conclusion</h3><div>The Alinity HCV Ag Next assay demonstrated excellent concordance to RNA testing in a US urban E.D. population. This data supports the utility of Alinity HCV Ag Next in diagnosis of active HCV infections.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"175 ","pages":"Article 105743"},"PeriodicalIF":4.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142568010","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Standardization and evaluation of an in-house ELISA for the detection of rabies antibody in a tertiary care centre in South India","authors":"Kalpana Thangavelu,&nbsp;Hubert D-J Daniel,&nbsp;Rajesh Kannangai,&nbsp;Asha Mary Abraham,&nbsp;Selva Kumar Velladurai,&nbsp;Dr. Shoba Mammen","doi":"10.1016/j.jcv.2024.105742","DOIUrl":"10.1016/j.jcv.2024.105742","url":null,"abstract":"<div><h3>Background</h3><div>Rapid fluorescent focus inhibition test (RFFIT), a neutralization-based assay for <strong>detecting rabies antibodies</strong>, is the gold standard. <strong>The National Action Plan for Dog Mediated Rabies Elimination (NAPRE) is a national program that strategizes the establishment of enzyme-linked immunosorbent assays (ELISA) to detect rabies antibodies.</strong></div></div><div><h3>Objective</h3><div>We developed an in-house ELISA to screen for <strong>rabies antibodies</strong> using rabies vaccine antigen to study vaccine response among health care workers (HCWs) who received pre-exposure prophylaxis and a few animal bite victims who received post-exposure prophylaxis with rabies vaccine.</div></div><div><h3>Study design</h3><div>A prospective study was carried out from April to September 2023 <strong>at</strong> the Department of Clinical Virology of a tertiary care <strong>center</strong> in South India. A total of 161 serum specimens, which included 155 serum samples from study participants and 6 samples from a reference laboratory (as controls), <strong>were</strong> obtained during the study period. Rabies antibody was determined by the in-house standardized ELISA developed using <strong>the rabies vaccine</strong> and compared with the reference assay, RFFIT. The accuracy indices of the in-house ELISA were estimated by MedCalc software (version 22.023).</div></div><div><h3>Results</h3><div>A panel of 86 positive and 75 negative serum samples was used for evaluating the in-house standardized ELISA. <strong>The sensitivity, specificity, positive and negative predictive values of the in-house ELISA were 98.8 %, 100 %, 100 %, and 98.7 % respectively. The accuracy of the in-house ELISA is 99.4 %.</strong></div></div><div><h3>Conclusion</h3><div>ELISA can be a practically feasible and less expensive assay compared to RFFIT which is a cumbersome procedure with a long turn-around time of 3–4 days.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"175 ","pages":"Article 105742"},"PeriodicalIF":4.0,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142578873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of yellow fever virus genome in urine following natural infection or vaccination: review of current knowledge 1985–2023.","authors":"Zsofia Igloi ,&nbsp;Laura Pezzi ,&nbsp;Remi N. Charrel ,&nbsp;Marion Koopmans","doi":"10.1016/j.jcv.2024.105740","DOIUrl":"10.1016/j.jcv.2024.105740","url":null,"abstract":"<div><h3>Background</h3><div>Yellow fever virus (YFV) is endemic in the (sub)tropical regions of Africa and South America and is prone to cause epidemics. Molecular testing of YFV by reverse transcription-polymerase chain reaction (RT-PCR) was recently adopted by WHO using blood. Urine is a non-invasive diagnostic specimen which has been proven to be useful in diagnosing several flavivirus infections. Until now, systematic data on the usefulness of urine in YFV molecular diagnostics was lacking.</div></div><div><h3>Methods</h3><div>We have carried out an extensive literature search using key words “yellow fever AND urine” in PubMed/Medline, Embase and Web of Science.</div></div><div><h3>Results</h3><div>The search resulted initially in 113 publications. All titles and abstracts were screened and 15 were analyzed in detail. After natural infection (10 articles), the detection ratio of YFV in blood with RT-PCR was 61 % (105/171 samples) vs. 59 % (139/234) in urine from patients with mild/severe infections. YFV could be first detected at average 4.3 days in blood vs. 6.1 days in urine and last detected till 17.2 vs. 31.1 days respectively (significant difference <em>p</em> &lt; 0.05). Viral load over time in blood was not statistically different from urine. Virus could be isolated from blood, urine and semen. Following vaccination, virus was detected longer in patients with vaccine adverse events (VAE) compared to healthy vaccinees (average 34 vs. 25 days, not significant <em>p</em> &gt; 0.05).</div></div><div><h3>Conclusion</h3><div>YFV can be detected in urine later but longer. Thus, we see added value for YF molecular diagnostics and sequencing and recommend it besides blood as a standard specimen, especially for late samples post onset.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"175 ","pages":"Article 105740"},"PeriodicalIF":4.0,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142560523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical accuracy of OncoPredict HPV Quantitative Typing (QT) assay on self-samples","authors":"Ardashel Latsuzbaia ,&nbsp;Marianna Martinelli ,&nbsp;Chiara Giubbi ,&nbsp;Kate Cuschieri ,&nbsp;Hana Elasifer ,&nbsp;Anna D. Iacobone ,&nbsp;Fabio Bottari ,&nbsp;Andrea F. Piana ,&nbsp;Roberto Pietri ,&nbsp;Giancarlo Tisi ,&nbsp;Franco Odicino ,&nbsp;Clementina E. Cocuzza ,&nbsp;Marc Arbyn ,&nbsp;European VALHUDES working group","doi":"10.1016/j.jcv.2024.105737","DOIUrl":"10.1016/j.jcv.2024.105737","url":null,"abstract":"<div><h3>Background</h3><div>The VALHUDES initiative was established to assess the clinical accuracy of HPV assays to detect cervical precancers using urine and vaginal self-samples compared to cervical clinician-collected samples. Here, the clinical performance of OncoPredict HPV Quantitative Typing (QT) assay (OncoPredict QT) was evaluated.</div></div><div><h3>Methods</h3><div>490 women referred to colposcopy self-collected a urine and a vaginal specimen using Colli-Pee and FLOQSwab, respectively. Subsequently, a colposcopy was performed, and a cervical sample was collected with Cervex-Brush, followed by biopsy if clinically indicated. Vaginal samples were transported dry and resuspended in 5 mL of eNAT medium, whilst cervical brushings were immediately transferred in 20 mL ThinPrep.</div></div><div><h3>Results</h3><div>The clinical sensitivity of OncoPredict HPV QT testing for CIN2+ in urine and vaginal self-samples was similar to cervical samples (ratios of 0.99 [95 % CI 0.94–1.05] and 1.00 [95 % CI 0.96–1.04]), respectively, when manufacturer's cut-offs were applied. The specificity for &lt;CIN2 on both self-samples was lower than on cervical samples (urine/cervical ratio = 0.91 [95 % CI 0.84–0.98]; vaginal/cervical ratio = 0.90 [95 % CI 0.84–0.98]). Cut-off optimisation improved specificity without compromising sensitivity. Median viral load values adjusted for cellularity were significantly higher in cervical samples compared to urine or vaginal self-samples, in general for all 12 high-risk HPV and in particular for HPV16, 18, 31, 33, 35, 45, 51, 58 (<em>p</em> &lt; 0.05). No difference was observed in median viral loads between urine and vaginal samples.</div></div><div><h3>Conclusion</h3><div>Following cut-off optimisation OncoPredict HPV QT assay demonstrated similar accuracy on self-collected versus cervical samples.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"175 ","pages":"Article 105737"},"PeriodicalIF":4.0,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142560524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"International external quality assessment study for detection of monkeypox virus by PCR supporting laboratory preparedness during the 2022–2023 mpox outbreak and beyond","authors":"Rosina Ehmann ,&nbsp;Oliver Donoso Mantke ,&nbsp;Elaine McCulloch ,&nbsp;Amani Yousef ,&nbsp;Alastair Ricketts ,&nbsp;Harry Staines ,&nbsp;Joachim J. Bugert ,&nbsp;Roman Wölfel ,&nbsp;Hubert G.M. Niesters","doi":"10.1016/j.jcv.2024.105741","DOIUrl":"10.1016/j.jcv.2024.105741","url":null,"abstract":"<div><h3>Background</h3><div>Diagnostic capabilities and correspondent External Quality Assessments (EQA) are key for outbreak preparedness. To support diagnostic facilities with a quality assessment of newly established monkeypox virus (MPXV) molecular diagnostic workflows, Quality Control for Molecular Diagnostics (QCMD) and the Bundeswehr Institute of Microbiology (IMB) piloted an international EQA study conducting four challenges from autumn 2022 to summer 2023 during the global mpox outbreak.</div></div><div><h3>Objectives</h3><div>To assess the performance (sensitivity/specificity) of molecular assays used by diagnostic laboratories.</div></div><div><h3>Study design</h3><div>Inactivated EQA panels were prepared and distributed containing seven samples of clade Ia and clade IIb MPXV strains at different viral concentrations, two specificity controls with other zoonotic orthopoxviruses (vaccinia and cowpox virus) and a negative control. Assessment was based on reported qualitative testing results.</div></div><div><h3>Results</h3><div>In this outbreak-related EQA study, a total of 192 laboratories from 37 countries reported 346 qualitative datasets. Overall, core samples were correctly detected by approximately 92 % of participants in all four challenges. While sensitivity performance was acceptable in at least 90 % of datasets correctly reported even for educational MPXV-positive samples with low viral concentration [10² genome equivalents (GE)/mL], several laboratories reported the educational specificity controls as false positives or were unable to differentiate MPXV from related orthopoxviruses.</div></div><div><h3>Conclusions</h3><div>Mpox is now a globally occurring infection with a demand for quality-assured diagnostic capabilities. The newly established EQA scheme presented here, offers a multi-purpose panel for orthopoxviruses with a focus on MPXV which will continue to ensure diagnostic quality in clinical settings with up-to-date sample panels.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"175 ","pages":"Article 105741"},"PeriodicalIF":4.0,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation, implementation and quality control of a Torque Teno Virus qPCR in a multinational clinical trial","authors":"E.J. Gore ,&nbsp;L. Gard ,&nbsp;P. Bourgeois ,&nbsp;D. Kulifaj ,&nbsp;E. McCulloch ,&nbsp;P.G. Spezia ,&nbsp;H.G.M. Niesters ,&nbsp;F. Maggi ,&nbsp;G. Bond ,&nbsp;C. Van Leer-Buter ,&nbsp;TTVguideTX consortium partners","doi":"10.1016/j.jcv.2024.105738","DOIUrl":"10.1016/j.jcv.2024.105738","url":null,"abstract":"<div><h3>Background</h3><div>Immunosuppressive medication after organ transplantation is usually dosed through therapeutic drug monitoring. Trough levels of antirejection medication however, do not adequately predict rejection or infections. The TTVguideIT trial is a multinational clinical trial evaluating the safety of Torque Teno Virus (TTV) load assessed by qPCR, as an alternative to trough level tacrolimus dosing.</div></div><div><h3>Methods</h3><div>Prior to, and during the clinical trial, the inter-and intra-laboratory variability, accuracy, and precision of the TTV R-GENE® assay was evaluated through analysis of internal quality control (IQC), external quality assessment (EQA) and linearity panels performed by the thirteen participating clinical virology laboratories, each using their standard testing platforms.</div></div><div><h3>Results</h3><div>IQC samples with a target of 4 log₁₀ copies/mL (cp/mL) were tested by the participating laboratories 130 times during the implementation phase and 987 times during the trial phase. They showed excellent accuracy, with an inter-laboratory standard deviation (SD) of 0.17 log₁₀ cp/mL, and an intra-laboratory SD of 0.03 to 0.20 log₁₀ cp/mL during the implementation phase, and an inter-laboratory SD of 0.19 log₁₀ cp/mL, and an intra-laboratory SD 0.07 to 0.18 log₁₀ cp/mL during the trial phase. Three EQA panels and three linearity panels showed similarly small variability during implementation as well as within the trial phase.</div></div><div><h3>Conclusion</h3><div>This data shows that TTV load measurement can be standardized for use in a multinational clinical trial. By using IQC, LP and EQA samples, the quality and integrity of the assay can be compared between laboratories and precise and accurate results can be generated.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"175 ","pages":"Article 105738"},"PeriodicalIF":4.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142604968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Parvovirus B19 remains an underestimated pathogen among infections during gestation in Argentina: Insights through the study of symptomatic and asymptomatic pregnant patients and newborns from Córdoba","authors":"María Belén Colazo Salbetti ,&nbsp;Gabriel Boggio ,&nbsp;Néstor Dicuatro ,&nbsp;Ana Paula Gudiño ,&nbsp;Nicolás Olivera ,&nbsp;Mauro Pedranti ,&nbsp;María Beatriz Isa ,&nbsp;Ariel Bertoldi ,&nbsp;María José Miranda ,&nbsp;Gonzalo Rodriguez Lombardi ,&nbsp;Paola Sicilia ,&nbsp;Gonzalo Castro ,&nbsp;Laura Moreno ,&nbsp;María Pilar Adamo","doi":"10.1016/j.jcv.2024.105739","DOIUrl":"10.1016/j.jcv.2024.105739","url":null,"abstract":"<div><h3>Background</h3><div>Parvovirus B19 (B19 V) infection during pregnancy can cause adverse fetal outcomes. Our aim was to characterize both clinical and asymptomatic maternal and neonatal cases by studying virological and serological markers of B19 V infection, and to sequence the complete genome of the circulating virus in Argentina.</div></div><div><h3>Methods</h3><div>Symptomatic patients were included based on maternal and/or fetal-neonatal signs attributable to B19 V infection during gestation. Pregnant patients were analyzed in either the timely diagnosis group (TD, samples obtained when symptoms were present and infection was suspected) or the retrospective diagnosis group (RD, samples collected immediately postpartum), and newborns were analyzed at birth. A sample of asymptomatic individuals was also analyzed. Diagnostic tests (PCR/qPCR/serology) and sequencing were performed on archived serum samples from 2018 to 2023, and clinical data were obtained from medical records.</div></div><div><h3>Results</h3><div>We studied 328 symptomatic patients, including 185 pregnant patients (73 TD and 112 RD) and 143 newborns. Among them, we identified 27/328 (8.2 %) positive cases (B19V+): 12/73 (16.4 %) in the TD group, 6/112 (5.4 %) in the RD group, and 9/143 (6.3 %) newborns. Within the 77 mother-newborn pairs included, there were 8 (10.4 %) B19 V infections and 6 cases of vertical transmission. Additionally, B19 V infection was detected in 26/310 (8.4 %) asymptomatic patients. Phylogenetic analysis identified genotype 1a as a circulating strain in Argentina.</div></div><div><h3>Conclusions</h3><div>Our findings highlight the need to raise awareness and enhance diagnostic approaches in Argentina to more effectively identify and manage B19 V infections during pregnancy in our region.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"175 ","pages":"Article 105739"},"PeriodicalIF":4.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142466621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}