Journal of clinical virology plus最新文献

{"title":"Characteristics and outcomes of HBV-infected patients with HBsAg and anti- HBs coexistence","authors":"Nguyen Thi Cam Huong ,&nbsp;Pham Thi Hai Men ,&nbsp;Brian Thanh Do ,&nbsp;Hoa Pham Thi Le","doi":"10.1016/j.jcvp.2025.100220","DOIUrl":"10.1016/j.jcvp.2025.100220","url":null,"abstract":"<div><h3>Background</h3><div>The coexistence of HBsAg and anti-HBs is a unique detection in chronic HBV-infected patients. This serological status has not been reported in Vietnamese cases.</div></div><div><h3>Objectives</h3><div>description of HBV viral markers, activity of hepatitis, and progression of HBV-infected patients with HBsAg and anti-HBs coexistence over a six-month follow-up period and define related factors to HBsAg seroclearance.</div></div><div><h3>Method</h3><div>cross-sectional descriptive study with a six-month follow-up on patients who tested positive for HBsAg and anti-HBs simultaneously at the Liver Clinic nit, Hospital for Tropical Diseases, Vietnam, from 12/2018 to 12/2019.</div></div><div><h3>Result</h3><div>122 patients with coexistence of HBsAg and anti-HBs were included. 50.8 % were male, with median age of 42 (30-53). The median of ALT was 34 (24-66) U/L, 24.6 % had chronic hepatitis, 32 % had positive HBeAg, median of HBsAg was 1.76 ((-0.25) – (2.87)) log IU/mL, median of anti-HBs was 50 (24-99) mIU/mL, median of HBVDNA was 3.45 (1.46-6.55) log copies/mL. Eighty-four patients were confirmed chronic HBV infection with anti-HBs coexistence (68.9 %), 26.2 % loss HBsAg, and 6 cases (4.9 %) loss anti-HBs, as chronic HBV infection. Without chronic hepatitis, HBsAg &lt;100 S/CO, high anti-HBs, low HBsAg quantification lower 3 log IU/mL, HBeAg negative, HBV DNA lower 1.7 log copies/mL related to HBsAg seroclearance.</div></div><div><h3>Conclusion</h3><div>The coexistence of HBsAg and anti-HBs occurs in both HBeAg-negative and HBeAg-positive patients. Most cases had high viral load, and one-fourth of cases had chronic liver diseases. HBsAg loss occurred in 26.2 % of cases and related to chronic liver disease, low HBsAg, high anti-HBs, and low HBV DNA.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 3","pages":"Article 100220"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144313444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dengue virus proteins: Dual drivers of pathogenesis and vaccine development","authors":"Haidar Ali ,&nbsp;Iffat Saleem ,&nbsp;Kashif Abdaal ,&nbsp;Mobeen Ur Rashid ,&nbsp;Imran Shahid ,&nbsp;Sadia Aziz ,&nbsp;Jing Yang ,&nbsp;Liaqat Ali","doi":"10.1016/j.jcvp.2025.100227","DOIUrl":"10.1016/j.jcvp.2025.100227","url":null,"abstract":"<div><div>This systematic review provides a comprehensive exploration of Dengue virus (DENV), focusing on its history, transmission dynamics, tropism, structural proteins, and potential vaccine development targets. Originating from sub-Saharan Africa, DENV has spread globally, facilitated by Aedes mosquitoes. The review highlights challenges posed by mosquito expansion and climate change on DENV transmission. It delves into DENV tropism, emphasizing interactions with immune cells and tissue-specific infection outcomes. Structural proteins, including Capsid, Pre-Membrane, and Envelope, are examined for their roles in viral assembly and maturation. Targeting strategies for structural proteins, particularly the Envelope protein domain III (EDIII), are discussed in the context of vaccine development. Additionally, non-structural proteins such as NS1, NS3, and NS5 are explored for their contributions to viral replication, host immune modulation and potential as both therapeutic targets and vaccine components. By integrating insights into both structural and non-structural elements of DENV, this review underscores the importance of a multifaceted approach to vaccine design and antiviral development aimed at effectively controlling dengue infection and its associated disease burden.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 3","pages":"Article 100227"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144687298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of recent SARS-CoV-2 infection on anti-spike protein immunoglobulin G II response after BNT162b2 vaccination","authors":"Daiki Tanno ,&nbsp;Yasuka Hara ,&nbsp;Yoshiyuki Sugaya ,&nbsp;Koji Okuaki ,&nbsp;Shuko Kobari ,&nbsp;Mitsuki Kitabatake ,&nbsp;Suguru Yui ,&nbsp;Tomoo Hidaka ,&nbsp;Masahiro Toyokawa ,&nbsp;Yumiko Kanari ,&nbsp;Kiwamu Nakamura ,&nbsp;Keiji Kanemitsu","doi":"10.1016/j.jcvp.2025.100224","DOIUrl":"10.1016/j.jcvp.2025.100224","url":null,"abstract":"<div><h3>Objectives</h3><div>Our hospital experienced a SARS-CoV-2 outbreak 3 months before staff vaccination was initiated. This study compared antibody responses to the first and second doses of BNT162b2 mRNA vaccine among staff with and without prior infection.</div></div><div><h3>Methods</h3><div>Serum anti-spike (S) protein immunoglobulin (anti-S) IgG, IgM, and anti-nuclear (N) protein IgG, IgM were measured 1 week before the first dose (baseline). Serum anti-S IgG II levels were sequentially measured at the baseline, 3 weeks after the first dose (immediately prior to the second dose), and 3 weeks and 6 months after the second dose to assess neutralization activity.</div></div><div><h3>Results</h3><div>Ten of the 83 staff had evidence of prior SARS-CoV-2 infection. The baseline anti-S IgG, IgG II, anti-N IgM, and anti-N IgG levels were significantly higher in those with prior infection. Three weeks after the first dose, the mean anti-S IgG II level was significantly higher in the prior-infection group (406.94 ± 163.44 AU/mL) than that in the uninfected group (40.43 ± 50.16 AU/mL; <em>p</em> &lt; 0.001). Three weeks after the second dose, the mean anti-S IgG II level was significantly lower than that after the first dose in the prior-infection group (240.28 ± 81.46 AU/mL; <em>p</em> = 0.007), and significantly higher in the uninfected group (341.45 ± 192.75 AU/mL; <em>p</em> &lt; 0.001). Six months after the second dose, the mean anti-S IgG II levels did not differ significantly between groups.</div></div><div><h3>Conclusions</h3><div>A single dose of BNT162b2 vaccine is sufficient to induce a peak anti-S IgG II response in recently infected individuals.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 3","pages":"Article 100224"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144481545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a novel point-of-care device detecting monkeypox virus using lyophilized microspheres and lateral flow strips","authors":"Howard James Shi,&nbsp;Joshua David Shi,&nbsp;Zhijie Li,&nbsp;Tim Hao Shi","doi":"10.1016/j.jcvp.2025.100219","DOIUrl":"10.1016/j.jcvp.2025.100219","url":null,"abstract":"<div><div>Real-time PCR has been used in clinical diagnostics as the gold standard for detecting monkeypox virus (MPXV), the cause of monkeypox disease (mpox). However, to better prevent the spread of mpox disease, especially in areas where PCR equipment is not available, fast and self-administered medical diagnostic devices are urgently needed. Therefore, we attempted to detect mpox by loop-mediated isothermal amplification (LAMP) using a method involving lyophilized microspheres and reading results by color change and lateral flow immunoassay strips. We first tested the optimal temperature for our LAMP assay and found that 65 °C presented optimal results. At this temperature, we then tested three different primer groups targeting different regions of the MPXV genes and found that the F3L-1 primer outperformed the others with a limit of detection (LoD) of 70 genome copies per reaction. Surprisingly, adding another primer group to the F3L-1 group only lowered the LoD to 60 genome copies per reaction. For interference assays, we selected substances and/or microorganisms that are commonly applied to or found on the skins of patients and showed that none of them interfered with the testing results at the indicated concentrations. Finally, we tested clinically collected human skin swabs containing MPXVs and demonstrated that our assay performed well with these samples at 1 ×, 2 ×, 3 ×, and 5 × LoD. Based on these findings, we propose a medical device that may be used as a point-of-care solution in areas where traditional PCR equipment is not available.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 3","pages":"Article 100219"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144270562","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of COVID-19 vaccines among healthcare workers in the Kingdom of Saudi Arabia","authors":"Zainah M. Al Shahrani,&nbsp;Yahya I. Alnshbah,&nbsp;Safaa A. Fallatah,&nbsp;Tabish Humayun,&nbsp;Ghazail M. Albeshi,&nbsp;Nawal M. Alanazi,&nbsp;Fayze Z. Aldalbehi,&nbsp;Eman A. Barnawi,&nbsp;Nawaf M. Almatrafi,&nbsp;Dalal H. Almutairi,&nbsp;Alhanouf A. Aldarami,&nbsp;Rayed A. Alasiri,&nbsp;Nasser H. Alshanbari,&nbsp;Khalid H. Alanazi,&nbsp;Hala M. Roushdy","doi":"10.1016/j.jcvp.2025.100222","DOIUrl":"10.1016/j.jcvp.2025.100222","url":null,"abstract":"<div><h3>Background</h3><div>Although COVID-19 vaccinations prevent infection, certain cases have been documented even after vaccination. This has raised questions regarding their safety and effectiveness.</div></div><div><h3>Aim</h3><div>Evaluating the efficacy of COVID-19 vaccines among healthcare workers in Saudi Arabia and assessing the severity of post-vaccination infection.</div></div><div><h3>Subject and Methods</h3><div>A cross-sectional design enrolling 124,742 healthcare workers (HCWs) with PCR-confirmed COVID-19 infection from March 2020 to March 2022. They were divided into two groups based on their vaccination status: a pre-vaccination group and a post-vaccination group. The data collected were obtained from the following hospitals (MOH, governmental non-MOH, and Private hospitals). Statistical analyses were performed using SPSS version 25.</div></div><div><h3>Results</h3><div>The overall mean COVID-19 positivity rates among the HCWs were higher following vaccination and were found to be 52.88 % (<em>n</em> = 65,968) compared to 47.12 % (<em>n</em> = 58,774) in the pre-vaccination group. The mortality and ICU admission rates significantly decreased in the post-vaccination group (36.5 % and 40.9 %) than pre-vaccination (63.5 % and 59.1 %). The cure rate increased significantly from 47.0 % in pre-vaccination to 53.0 % in the post-vaccination group. Gender, nationality, job title, hospital category, and vaccine type were all associated with a significantly higher risk of infection following vaccination (<em>p</em> &gt; 0.05).</div></div><div><h3>Conclusion</h3><div>Vaccinated healthcare personnel remain susceptible to infection and should be instructed to take all necessary infection control precautions to avoid future COVID-19 pandemics. Rigorous oversight of the private sector is essential for conducting focused audits and evaluations of infection control policies in private healthcare environments.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 3","pages":"Article 100222"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144519209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Decrease in SinglePlex Viral PCRs Use and acyclovir utilization following implementation of The BioFire Meningitis/Encephalitis Panel at A Tertiary Care Cancer Center","authors":"Tracy McMillen ,&nbsp;Eleanor Powell ,&nbsp;Krupa Jani ,&nbsp;Marco R. Scipione ,&nbsp;Susan K. Seo ,&nbsp;N. Esther Babady","doi":"10.1016/j.jcvp.2025.100221","DOIUrl":"10.1016/j.jcvp.2025.100221","url":null,"abstract":"<div><h3>Purpose</h3><div>Meningitis and encephalitis are medical emergencies requiring prompt intervention. The BioFire Meningitis/Encephalitis (M/E) panel (BioFire® Diagnostics, Salt Lake City, UT) is approved by the U.S. Food and Drug Administration (FDA) for the detection of 14 pathogens directly on cerebrospinal fluid (CSF). Impact of the M/E panel on antiviral and viral tests use has been evaluated in a several patient populations but data in cancer patients remain limited. In this study, we evaluated the impact of the M/E panel within a year of its implementation on both acyclovir and singleplex viral PCR test utilization in a cancer patient population.</div></div><div><h3>Methods</h3><div>This was a pre- and post-intervention study. Data from patients tested in the year prior to the intervention and one year following the intervention were extracted from the laboratory and clinical information systems.</div></div><div><h3>Results</h3><div>A total of 476 patients (207 pre-intervention and 269 post-intervention) were tested during the study period. In the post-intervention period, the number of targeted viral tests was reduced by 64.9 % (703 to 247 PCRs), and the total number of patients treated with acyclovir was reduced by 29.1 % (82 patients vs 45 patients) with a reduction in the duration of therapy from 7.33 days to 4.47 days in the post-intervention period (<em>p</em> &lt; 0.0274).</div></div><div><h3>Conclusion</h3><div>The implementation of the M/E panel contributed to a reduction in the number of singleplex PCR tests performed and a reduction in the utilization and duration of acyclovir therapy in our cancer patient population.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 3","pages":"Article 100221"},"PeriodicalIF":1.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144290544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Persistent nucleic acids from endemic human coronaviruses in adenoids: Do they enhance children's immune response to SARS-CoV-2 infection?","authors":"Kira Winkler ,&nbsp;Lucia Otten ,&nbsp;Alina Abramian ,&nbsp;Eva Weber ,&nbsp;Florian Winkler ,&nbsp;Niklas Klümper ,&nbsp;Anna Maria Schmidt ,&nbsp;Zahrasadat Safavieh ,&nbsp;Anna Maria Eis-Hübinger ,&nbsp;Stephan Herberhold","doi":"10.1016/j.jcvp.2025.100208","DOIUrl":"10.1016/j.jcvp.2025.100208","url":null,"abstract":"<div><h3>Introduction</h3><div>Human Coronaviruses (HCoVs), including HCoV-OC43, HCoV-HKU1, HCoV-NL63, and HCoV-229E, are endemic viruses that circulate globally and infect humans. In contrast to SARS-CoV-2, which causes more severe symptoms, these endemic HCoVs typically induce mild cold symptoms and confer only temporary immunity [<span><span>1</span></span>,<span><span>2</span></span>]]. Understanding the presence and persistence of HCoVs in the human population, particularly in asymptomatic individuals, is crucial for understanding their potential role in immunity and viral dynamics.</div></div><div><h3>Methods</h3><div>This study aimed to investigate the presence of nucleic acids of endemic HCoVs (HCoV-OC43, HCoV-HKU1, HCoV-NL63, and HCoV-229E) in individuals without symptoms of acute respiratory infection. A total of 78 adenoid tissue samples were collected from children (up to 10 years old) without current symptoms of airway infection. The samples were analyzed using RT-nested PCR to detect viral RNA.</div></div><div><h3>Results</h3><div>Of the 78 adenoid samples, 24 (30,8 %) tested positive for at least one type of endemic HCoV. Additionally, throat swabs were collected from 56 participants immediately before surgery. Endemic HCoV RNA was rarely detected in these throat swabs, with only 3 out of 56 samples testing positive.</div></div><div><h3>Discussion</h3><div>Our findings suggest the frequent presence of endemic HCoV nucleic acids in the lymphatic tissue of Waldeyer's ring, especially in children. This observation supports the concept of these viruses acting as immune triggers. The persistence of viral remnants in the adenoid tissue may contribute to continuous immune surveillance, which could have implications for immunity to future infections and for understanding viral dynamics in asymptomatic individuals.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 2","pages":"Article 100208"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143724847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Monitoring humoral immune response following COVID-19 immunization and booster dose: A prospective study in tunisian healthcare workers","authors":"Chiraz Naffouti ,&nbsp;Hela Hannachi ,&nbsp;Wafa Aissi ,&nbsp;Ikram Ayari ,&nbsp;Fatma Ben Salem ,&nbsp;Manel Hamdoun ,&nbsp;Olfa Bahri","doi":"10.1016/j.jcvp.2025.100210","DOIUrl":"10.1016/j.jcvp.2025.100210","url":null,"abstract":"<div><h3>Background</h3><div>As SARS-CoV-2 vaccines are deployed worldwide, assessing the kinetics and magnitude of anti-SARS-CoV-2 antibodies post-vaccination at various time points is crucial to optimize immunization strategies. This study aims to evaluate the humoral response in healthcare workers (HCWs) after primary vaccination and booster doses both in the short and long term and to examine the effect of preexisting immunity, age, sex, and vaccine type on this response.</div></div><div><h3>Methods</h3><div>Prior to the primary vaccination, an initial serology was performed to determine the immunity to SARS-CoV-2. Based on the outcomes of this serology or the rapid diagnostic tests, participants were split into two groups: COVID-19-free and COVID-19-recovered people. In each group, serological tests were conducted one and six months following the first vaccination(M1,M6).The vaccines administrated were mRNA, viral vector and inactivated viral vaccines. The follow-up was done one and six months after the booster dose (mRNA vaccine) (M1B,M6B). Anti-SARS-CoV-2 anti-S IgG were evaluated using the Access SARS-CoV-2 IgGII® test (BECKMAN COULTER).</div></div><div><h3>Results</h3><div>A total of 319 HCWs were sampled. For COVID-19-recovered people, the median anti-S level was significantly higher at 130AU/mL(IQR 51.5–184) compared to 89AU/mL(IQR 34.1–145.4),<strong><em>p</em></strong> <strong>=</strong> <strong>0.0042.</strong> At every stage, there was a statistically significant increase in anti-S levels in adenovirus or inactivated vaccinations. Participants who received mRNA vaccines had significantly the highest anti-S levels at M1, M6, and M6B, according to post-hoc analysis. The anti-S level increased significantly one month after the third dose, from 12.7AU/mL(IQR 6.4–28.4) to 140.6AU/mL(IQR 88.6–258.5),<strong><em>p</em></strong> <strong>&lt;</strong> <strong>0.001</strong>. Six months after the booster dose, the anti-S titer dropped but remained positive at 40.8AU/mL(IQR22.5–91.3). In every time period, there was no correlation or association between anti-S level and age or sex.</div></div><div><h3>Conclusion</h3><div>The administration of mRNA vaccines allows to an enhanced humoral response in individuals recovering from COVID-19. Six months following the initial immunization, one dose has the same immunogenicity as two doses. However, a third dose of the mRNA vaccine should be given to lengthen the duration of the humoral in both COVID-19-free and COVID-19-recovered people. Booster doses should be administrated to high risk group who can transmit the disease to susceptible patient.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 2","pages":"Article 100210"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143817528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multicenter performance comparison of the hepatitis C antibody serology assay on the new Atellica integrated chemistry and immunoassay analyzer","authors":"Joe M. El-Khoury ,&nbsp;Anthony Bonito ,&nbsp;Rachel Fonstad ,&nbsp;Michael Anostario ,&nbsp;Michael Quintanilla ,&nbsp;Neil Birmingham ,&nbsp;Amin A. Mohammad","doi":"10.1016/j.jcvp.2025.100215","DOIUrl":"10.1016/j.jcvp.2025.100215","url":null,"abstract":"<div><h3>Background &amp; Aims</h3><div>To ensure more effective identification of individuals at risk of transmitting hepatitis C virus (HCV), the Centers for Disease Control suggest that all adults should undergo a one-time anti-HCV serological testing, driving increase in demand for high-performance, automated HCV serology assays. The Atellica CI analyzer is a new stand-alone, high-throughput integrated chemistry and immunoassay (IM) analyzer utilizing Atellica assays. This study evaluated the performance of the Atellica IM anti-HCV antibodies (aHCV) assay on the Atellica CI analyzer across 3 sites in the United States (U.S).</div></div><div><h3>Methods</h3><div>Precision, cutoff bias analysis and qualitative method comparison studies were performed on Atellica CI and Atellica IM analyzers. Method comparison was evaluated using serum specimens (<em>n</em> = 278) from aHCV positive individuals and negative individuals at increased risk for exposure to HCV, as well as 9 commercially available HCV seroconversion panels.</div></div><div><h3>Result</h3><div>Repeatability and reproducibility %CVs were &lt;3.0 % and 6.5 % respectively, on the Atellica CI, and equivalent on each analyzer for samples at or above 0.80 Index. Bias in Index values around cutoff was estimated at – 7 % between the analyzers. Negative and positive agreement between the Atellica CI and Atellica IM analyzers were 100 % and 99.23 %, respectively, for aHCV samples, and 100 % for the 9 HCV seroconversion panels tested.</div></div><div><h3>Conclusion</h3><div>This is the first report on analytical and clinical performance of the Atellica IM aHCV assay on the Atellica CI analyzer. The findings demonstrate its reliability for HCV serological testing, its consistency with the Atellica IM analyzer and provide practical considerations for operating both analyzers interchangeably, potentially supporting workflow efficiency in a hub-and-spoke laboratory setting.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 2","pages":"Article 100215"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144072664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnosis of SARS-CoV-2: Experience with rapid immunochromatography tests and RT‒qPCR","authors":"David Alejandro Cabrera Gaytán ,&nbsp;Porfirio Felipe Hernández Bautista ,&nbsp;Clara Esperanza Santacruz Tinoco ,&nbsp;Julio Elias Alvarado Yaah ,&nbsp;Yu-Mei Anguiano Hernández ,&nbsp;Bernardo Martínez Miguel ,&nbsp;Alfonso Vallejos Parás ,&nbsp;Lumumba Arriaga Nieto ,&nbsp;Nancy Sandoval Gutiérrez ,&nbsp;Concepción Grajales Muñiz ,&nbsp;Alejandro Moctezuma Paz ,&nbsp;Leticia Jaimes Betancourt","doi":"10.1016/j.jcvp.2025.100207","DOIUrl":"10.1016/j.jcvp.2025.100207","url":null,"abstract":"<div><h3>Background</h3><div>Mexico has experienced six waves were experiences between 2019 and 2023 of coronavirus disease 2019 (COVID-19). In the first wave, diagnosis relied on RT‒qPCR; rapid tests for SARS‒CoV‒2 were introduced from the second wave onward. However, the patterns of results with this test in Mexico have not been documented in population-based studies.</div></div><div><h3>Objective</h3><div>To describe the temporal patterns of the results from RT-qPCR and rapid immunochromatography tests for SARS-CoV-2 detection from the second to the sixth epidemic wave in Mexico.</div></div><div><h3>Materials and methods</h3><div>This was a multicenter study at the national level. The operational definition of suspected cases of viral respiratory illness, confirmed cases of SARS-CoV-2 in Mexico, and data for asymptomatic individuals who required rapid testing between 2020 and 2023 were employed; testing was employed for the entirety of the four years. Positivity was estimated per epidemiological week, state, and condition for both tests. Spearman's correlation coefficient, trend chi-square analysis, and odds ratios with 95 % confidence intervals were used.</div></div><div><h3>Results</h3><div>A total of 1749,765 cases had RT‒qPCR data recorded from 2020 to 2023, and 8356,903 cases with rapid tests were conducted for virus identification. Compared with the rest of the country, the southeastern region exhibited different patterns. The positivity rate of rapid tests from the epidemiological surveillance system was lower than that of RT‒qPCR during interepidemics periods, whereas the positivity rate of rapid tests for symptomatic individuals was higher than that of RT‒qPCR tests over two years.</div></div><div><h3>Conclusion</h3><div>Rapid tests for SARS-CoV-2 identification in Mexico were affordable and timely at the local level. These tests revealed differing epidemic wave patterns in the southeastern region of the country.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 2","pages":"Article 100207"},"PeriodicalIF":1.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143785855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}