Pub Date : 2025-10-01Epub Date: 2025-08-18DOI: 10.1016/j.jcv.2025.105856
Jacky Lu , Jessica Flores-Vazquez , Jaehyeon Lee , Leila C. Posch , Cristina Costales , Jennifer Dien Bard
Meningitis and encephalitis can lead to severe morbidity and result in permanent neurologic deficits in children, but outcomes differ depending on the causative pathogen. Early diagnosis of viral meningitis may allow for appropriate management, including avoidance of antimicrobial treatment and hospital admission. We sought to determine the clinical utility of a multiplexed meningitis-encephalitis (ME) panel at a quaternary care pediatric institution in patients diagnosed with human enterovirus (HEV) and human parechovirus (HPeV) meningitis. Retrospective analysis of patients between June 2016 and October 2023 positive for HEV or HPeV (n = 66) by ME panel were compared to HEV or HPeV positive patients (n = 53) diagnosed by standalone PCR (polymerase chain reaction) between December 2011 and May 2016. The turnaround time (TAT) for ME panel was 2.67 h compared to 22.05 h for standalone polymerase chain reaction (PCR) (p < 0.0001). In patients with cerebrospinal fluid (CSF) collected and tested by ME panel within 72 h of admission compared to standalone PCR, the duration of intravenous acyclovir therapy was significantly reduced (3.88 vs 16.03 h, P = 0.03). Despite viral detection by molecular methods, patients remained on antibiotics until CSF cultures were confirmed to be negative after 48 h of incubation. Implementation of ME panel in a pediatric hospital improved overall time to diagnosis of viral (or aseptic) ME. Although not statistically significant, the median length of stay (LOS) of patients positive for HEV or HPeV by ME panel was reduced by 0.51 days when compared to standalone PCR (1.95 vs. 2.46 days, p = 0.66).
脑膜炎和脑炎可导致严重的发病率，并导致儿童永久性的神经功能缺损，但结果因致病病原体而异。病毒性脑膜炎的早期诊断可能允许适当的管理，包括避免抗微生物治疗和住院。我们试图确定在一家四级护理儿科机构诊断为人类肠病毒（HEV）和人类parechovirus （HPeV）脑膜炎的患者中多重脑膜炎-脑炎（ME）小组的临床应用。回顾性分析了2016年6月至2023年10月期间由ME小组诊断的HEV或HPeV阳性患者（n = 66）与2011年12月至2016年5月期间通过独立PCR（聚合酶链反应）诊断的HEV或HPeV阳性患者（n = 53）。ME面板的周转时间（TAT）为2.67 h，而独立聚合酶链反应（PCR）的周转时间为22.05 h （p <； 0.0001）。与单独PCR相比，在入院72 h内收集脑脊液（CSF）并进行ME panel检测的患者，静脉注射阿昔洛韦的持续时间显著缩短（3.88 vs 16.03 h, P = 0.03）。尽管采用分子方法检测病毒，但患者仍继续使用抗生素，直到培养48 h后确认脑脊液培养为阴性。在儿科医院实施ME面板提高了病毒性（或无菌性）ME诊断的总体时间。虽然没有统计学意义，但与独立PCR相比，mepanel检测出HEV或HPeV阳性的患者的中位住院时间（LOS）减少了0.51天（1.95天对2.46天，p = 0.66）。
{"title":"Impact on hospital length of stay and antimicrobial usage in children diagnosed with viral meningitis by rapid multiplexed PCR assay","authors":"Jacky Lu , Jessica Flores-Vazquez , Jaehyeon Lee , Leila C. Posch , Cristina Costales , Jennifer Dien Bard","doi":"10.1016/j.jcv.2025.105856","DOIUrl":"10.1016/j.jcv.2025.105856","url":null,"abstract":"<div><div>Meningitis and encephalitis can lead to severe morbidity and result in permanent neurologic deficits in children, but outcomes differ depending on the causative pathogen. Early diagnosis of viral meningitis may allow for appropriate management, including avoidance of antimicrobial treatment and hospital admission. We sought to determine the clinical utility of a multiplexed meningitis-encephalitis (ME) panel at a quaternary care pediatric institution in patients diagnosed with human enterovirus (HEV) and human parechovirus (HPeV) meningitis. Retrospective analysis of patients between June 2016 and October 2023 positive for HEV or HPeV (n = 66) by ME panel were compared to HEV or HPeV positive patients (n = 53) diagnosed by standalone PCR (polymerase chain reaction) between December 2011 and May 2016. The turnaround time (TAT) for ME panel was 2.67 h compared to 22.05 h for standalone polymerase chain reaction (PCR) (p < 0.0001). In patients with cerebrospinal fluid (CSF) collected and tested by ME panel within 72 h of admission compared to standalone PCR, the duration of intravenous acyclovir therapy was significantly reduced (3.88 vs 16.03 h, P = 0.03). Despite viral detection by molecular methods, patients remained on antibiotics until CSF cultures were confirmed to be negative after 48 h of incubation. Implementation of ME panel in a pediatric hospital improved overall time to diagnosis of viral (or aseptic) ME. Although not statistically significant, the median length of stay (LOS) of patients positive for HEV or HPeV by ME panel was reduced by 0.51 days when compared to standalone PCR (1.95 vs. 2.46 days, p = 0.66).</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"Article 105856"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144885699","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}
Pub Date : 2025-10-01Epub Date: 2025-08-05DOI: 10.1016/j.jcv.2025.105852
Long Chen, Hong Yang, Hai-Long Zhang, Xiao-Lu Shi, Bo Peng, Jun Meng
Objectives: To investigate the etiological characteristics of acute conjunctivitis in Shenzhen, China.
Methods: A total of 1234 conjunctival swabs collected between 2018 and 2024 were examined for coxsackievirus A24 variant (CVA24v), enterovirus D70 (EV-D70) and human adenovirus (HAdV). Complete VP1 sequences of CVA24v strains were determined and analyzed. HAdV was genotyped by PCR methods targeting the three genes (penton base, hexon and fiber) and sequencing. SPSS 22.0 software was used for statistical analysis.
Results: CVA24v was first detected in 2023, with a detection rate of 33.3 % (63/189). No EV-D70 was detected in 2018-2024. The annual distributions of HAdV-infected patients were 52.6 % (101/192), 62.7 % (111/177), 21.1 % (37/175), 9.0 % (14/155), 10.5 % (17/162), 15.9 % (30/189) and 21.7 % (40/184), respectively. CVA24v strains from this study clustered in a clade with significant temporal aggregation characteristic within the genotype GIV. Eight amino acid variation sites (T11A, I16L, K20I, L32P, K105R, A146T, R277G and P280S) were observed in VP1 sequences of CVA24v strains from this study when compared to the close strains. Conjunctivitis patients with one of the three symptoms (weakness, fever and blurred vision) had a higher detection rate of HAdV. Eleven known HAdV genotypes (HAdV-B3, -B14, -B21, HAdV-D8, -D37, -D42, -D53, -D64, -D85, -D115 and HAdV-E4) and 7 unknown genotypes were detected in 2020-2024, with HAdV-D37 (30.9 %), HAdV-D115 (21.1 %) and HAdV-B3 (17.1 %) being the three predominant genotypes.
Conclusions: The unique genetic characteristics were observed in Shenzhen CVA24v strains. HAdVs associated with conjunctivitis exhibited a high degree of genotypic diversity in Shenzhen, and HAdV-D115 related to conjunctivitis was first reported in this study.
{"title":"Pathogen surveillance of acute conjunctivitis reveals recent emergence of coxsackievirus A24 variants and high genotypic diversity of human adenoviruses in Shenzhen, China, 2018-2024.","authors":"Long Chen, Hong Yang, Hai-Long Zhang, Xiao-Lu Shi, Bo Peng, Jun Meng","doi":"10.1016/j.jcv.2025.105852","DOIUrl":"10.1016/j.jcv.2025.105852","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate the etiological characteristics of acute conjunctivitis in Shenzhen, China.</p><p><strong>Methods: </strong>A total of 1234 conjunctival swabs collected between 2018 and 2024 were examined for coxsackievirus A24 variant (CVA24v), enterovirus D70 (EV-D70) and human adenovirus (HAdV). Complete VP1 sequences of CVA24v strains were determined and analyzed. HAdV was genotyped by PCR methods targeting the three genes (penton base, hexon and fiber) and sequencing. SPSS 22.0 software was used for statistical analysis.</p><p><strong>Results: </strong>CVA24v was first detected in 2023, with a detection rate of 33.3 % (63/189). No EV-D70 was detected in 2018-2024. The annual distributions of HAdV-infected patients were 52.6 % (101/192), 62.7 % (111/177), 21.1 % (37/175), 9.0 % (14/155), 10.5 % (17/162), 15.9 % (30/189) and 21.7 % (40/184), respectively. CVA24v strains from this study clustered in a clade with significant temporal aggregation characteristic within the genotype GIV. Eight amino acid variation sites (T11A, I16L, K20I, L32P, K105R, A146T, R277G and P280S) were observed in VP1 sequences of CVA24v strains from this study when compared to the close strains. Conjunctivitis patients with one of the three symptoms (weakness, fever and blurred vision) had a higher detection rate of HAdV. Eleven known HAdV genotypes (HAdV-B3, -B14, -B21, HAdV-D8, -D37, -D42, -D53, -D64, -D85, -D115 and HAdV-E4) and 7 unknown genotypes were detected in 2020-2024, with HAdV-D37 (30.9 %), HAdV-D115 (21.1 %) and HAdV-B3 (17.1 %) being the three predominant genotypes.</p><p><strong>Conclusions: </strong>The unique genetic characteristics were observed in Shenzhen CVA24v strains. HAdVs associated with conjunctivitis exhibited a high degree of genotypic diversity in Shenzhen, and HAdV-D115 related to conjunctivitis was first reported in this study.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"105852"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144812096","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}
Pub Date : 2025-10-01Epub Date: 2025-07-22DOI: 10.1016/j.jcv.2025.105843
Manfred Accrombessi, Cheryl Johnson, Alaleh Abadpour, Jean De Dieu Anoubissi, Joseph Fokam, Araz Chiloyan, Iryna Andrianova, Hamakwa Mantina, Agai Kherbino Akec, Fatou Ousmane Sall, Abdelaye Keita, Elizabeth Telan, Adoum Fouda Abderrazzack, Chatté Adawaye, Rose Wafula, Stephen Ayisi-Addo, Monkoe S Leqheka, Jacob Lusekelo Mwambeta, Jeremie Muwonga Masidi, Dramane Kania, Anita Sands, Rachel Baggaley, Jean-François Etard, Céline Lastrucci
This study highlights the importance of verifying HIV testing algorithms to reduce the risk of misdiagnoses caused by common false reactivity. Between 2020 and 2023, WHO supported 14 countries to assess rates of false reactivity and shared false reactivity across HIV rapid diagnostic tests (RDTs) used in HIV testing services. The study involved 26,278 results from 22 different RDT products, with sample sizes ranging from 100 to 302 results per country. The number of RDT products assessed varied between 4 and 13 per country. False reactivity rates ranged from 0 % to 3.32 %, with one country reporting a high false reactivity rate of over 4 % for one RDT. Five countries have no shared false reactivity between RDTs, while the remaining eight countries shared false reactivity across one to six pairs of RDT products. These findings were used to inform national policy, with more than 90 % of countries introducing new RDT products into their HIV testing algorithm based on these results. The study concludes that rates of false reactivity and shared false reactivity between RDT products vary across countries. Therefore, conducting verification studies is crucial for updating national HIV testing algorithms and ensuring accurate diagnosis while also facilitating the market entry of new HIV testing products.
{"title":"Heterogeneity of false reactivity profiles of HIV assays while optimizing national HIV testing algorithms: Findings from a multi-country analysis.","authors":"Manfred Accrombessi, Cheryl Johnson, Alaleh Abadpour, Jean De Dieu Anoubissi, Joseph Fokam, Araz Chiloyan, Iryna Andrianova, Hamakwa Mantina, Agai Kherbino Akec, Fatou Ousmane Sall, Abdelaye Keita, Elizabeth Telan, Adoum Fouda Abderrazzack, Chatté Adawaye, Rose Wafula, Stephen Ayisi-Addo, Monkoe S Leqheka, Jacob Lusekelo Mwambeta, Jeremie Muwonga Masidi, Dramane Kania, Anita Sands, Rachel Baggaley, Jean-François Etard, Céline Lastrucci","doi":"10.1016/j.jcv.2025.105843","DOIUrl":"10.1016/j.jcv.2025.105843","url":null,"abstract":"<p><p>This study highlights the importance of verifying HIV testing algorithms to reduce the risk of misdiagnoses caused by common false reactivity. Between 2020 and 2023, WHO supported 14 countries to assess rates of false reactivity and shared false reactivity across HIV rapid diagnostic tests (RDTs) used in HIV testing services. The study involved 26,278 results from 22 different RDT products, with sample sizes ranging from 100 to 302 results per country. The number of RDT products assessed varied between 4 and 13 per country. False reactivity rates ranged from 0 % to 3.32 %, with one country reporting a high false reactivity rate of over 4 % for one RDT. Five countries have no shared false reactivity between RDTs, while the remaining eight countries shared false reactivity across one to six pairs of RDT products. These findings were used to inform national policy, with more than 90 % of countries introducing new RDT products into their HIV testing algorithm based on these results. The study concludes that rates of false reactivity and shared false reactivity between RDT products vary across countries. Therefore, conducting verification studies is crucial for updating national HIV testing algorithms and ensuring accurate diagnosis while also facilitating the market entry of new HIV testing products.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"105843"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12439682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144816831","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}
Pub Date : 2025-10-01Epub Date: 2025-08-05DOI: 10.1016/j.jcv.2025.105849
Sébastien Lhomme, Isabelle Da Silva, Oriane Cabanel, Estelle Raguin, Guillaume Martin-Blondel, Nassim Kamar, Jacques Izopet, Florence Abravanel
Introduction: We evaluated the performance of the automated AltoStar JCV PCR platform for detecting and quantifying JC Polyomavirus (JCPyV) DNA in samples including urine, plasma and cerebrospinal fluid.
Methods and results: Using the NIBSC JCPyV DNA standard, the assay was linear from 1 to 6 log IU/mL standard and the limit of detection determined by Probit analysis corresponded to 9.3 [95 % CI: 7.0-16.5] IU/mL. Specificity was accessed by testing urines containing a high concentration of BK Polyomavirus; none tested positive for JCPyV. The intra-run and inter-run standard deviations were 0.02 IU/mL and 0.35 IU/mL, respectively. Lastly, clinical performance was determined by testing 45 samples quantified previously with a laboratory-developed test (LDT). The assays were concordant for 42/45 samples. One of the 3 samples that tested negative with the AltoStar assay had a low JCpyV DNA concentration. We were unable to re-test the 3 negative samples due to insufficient volume. A conservation problem could not be ruled out for the 3 samples with discordant results.
Conclusions: The AltoStar platform enables highly accurate testing for the detection and quantification of JCPyV DNA with very low limit of detection. This allowed us to shorten turnaround times and save time for technical staff.
{"title":"Performance of a commercial assay for detecting JC Polyomavirus DNA in human samples.","authors":"Sébastien Lhomme, Isabelle Da Silva, Oriane Cabanel, Estelle Raguin, Guillaume Martin-Blondel, Nassim Kamar, Jacques Izopet, Florence Abravanel","doi":"10.1016/j.jcv.2025.105849","DOIUrl":"10.1016/j.jcv.2025.105849","url":null,"abstract":"<p><strong>Introduction: </strong>We evaluated the performance of the automated AltoStar JCV PCR platform for detecting and quantifying JC Polyomavirus (JCPyV) DNA in samples including urine, plasma and cerebrospinal fluid.</p><p><strong>Methods and results: </strong>Using the NIBSC JCPyV DNA standard, the assay was linear from 1 to 6 log IU/mL standard and the limit of detection determined by Probit analysis corresponded to 9.3 [95 % CI: 7.0-16.5] IU/mL. Specificity was accessed by testing urines containing a high concentration of BK Polyomavirus; none tested positive for JCPyV. The intra-run and inter-run standard deviations were 0.02 IU/mL and 0.35 IU/mL, respectively. Lastly, clinical performance was determined by testing 45 samples quantified previously with a laboratory-developed test (LDT). The assays were concordant for 42/45 samples. One of the 3 samples that tested negative with the AltoStar assay had a low JCpyV DNA concentration. We were unable to re-test the 3 negative samples due to insufficient volume. A conservation problem could not be ruled out for the 3 samples with discordant results.</p><p><strong>Conclusions: </strong>The AltoStar platform enables highly accurate testing for the detection and quantification of JCPyV DNA with very low limit of detection. This allowed us to shorten turnaround times and save time for technical staff.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"105849"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144804232","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}
Pub Date : 2025-10-01Epub Date: 2025-08-06DOI: 10.1016/j.jcv.2025.105850
Romina Salpini, Lorenzo Piermatteo, Gian Paolo Caviglia, Ada Bertoli, Maurizia Rossana Brunetto, Bianca Bruzzone, Annapaola Callegaro, Cinzia Caudai, Daniela Cavallone, Luchino Chessa, Fernando Coghe, Nicola Coppola, Nunzia Cuomo, Stefano D'Anna, Mariantonietta Di Stefano, Floriana Facchetti, Claudio Farina, Donatella Ferraro, Elisa Franchin, Daniela Francisci, Silvia Galli, Anna Rosa Garbuglia, William Gennari, Valeria Ghisetti, Pietro Lampertico, Sergio Lo Caputo, Nadia Marascio, Stefano Menzo, Valeria Micheli, Grazia Anna Niro, Antonella Olivero, Pierpaolo Paba, Concetta Ilenia Palermo, Orazio Palmieri, Stefania Paolucci, Mariantonietta Pisaturo, Teresa Pollicino, Giuseppina Raffa, Teresa Santantonio, Giulia Torre, Ombretta Turriziani, Sergio Uzzau, Sara Colonia Uceda Renteria, Marialinda Vatteroni, Maurizio Zazzi, Antonio Craxì, Francesca Ceccherini-Silberstein, Valentina Svicher, Marco Arosio, Sabrina Bastianelli, Annamaria Gentile, Federica A M Giardina, Anna Gidari, Rosalba Govoni, Gabriele Ibba, Alessandro Loglio, Alessandra Lombardi, Chiara Mascarella, Fabrizio Maggi, Giovanni Matera, Chiara Mazzei, Maria Grazia Milia, Angela Quirino, Adriana Raddi, Rosetta Scioscia, Sara Tagliazucchi, Michele Totaro, Rea Valaperta
Introduction: A reliable quantification of hepatitis D virus (HDV) RNA is of paramount importance for monitoring patients under antiviral therapy. This quality control study compares the diagnostic performances of quantitative HDV-RNA assays used in clinical practice.
Methods: Two HDV-RNA sample panels were quantified in 30 centers by RoboGene (N = 9 laboratories), EurobioPlex (N = 7), RealStar (N = 4), AltoStar (N = 1), Bosphore (N = 3), Bosphore-on-InGenius (N = 1), Dia.Pro (N = 2), Nuclear-Laser-Medicine (N = 1) and 3 in-house assays. Panel A and B comprised 8 serial dilutions of WHO/HDV standard (range: 0.5-5.0 log10 IU/ml) and 20 clinical samples (range: 0.5-6.0 log10 IU/ml), respectively. The following parameters were determined: sensitivity by 95 % LOD (limit of detection), precision by intra- and inter-run CV (coefficient of variation), accuracy by the differences between expected-observed HDV-RNA, linearity by linear regression analysis.
Results: 95 % LOD varied across assays and centers underlining heterogeneous sensitivities: AltoStar had the lowest 95 % LOD (3 IU/ml) followed by RealStar (10 [min-max: 3-316] IU/ml), Bosphore-on-InGenius (10 IU/ml), RoboGene (31 [3-316] IU/ml), Nuclear-Laser-Medicine (31 IU/ml) and EuroBioplex (100 [100-316] IU/ml). Moreover, 6 assays (RoboGene, EurobioPlex, RealStar, AltoStar, Nuclear-Laser-Medicine and In-house) showed <0.5 log10 IU/ml differences between expected and observed HDV-RNA for all dilutions while other assays had >1 log10 IU/ml underestimations. RealStar, Bosphore-on-InGenius and EurobioPlex had the highest precision (mean intra-run CV < 20 %). Inter-run CV was higher for all assays, with CVs < 25 % for RealStar, AltoStar, Nuclear-Laser-Medicine and EurobioPlex. Seven assays (RoboGene/AltoStar/RealStar/EurobioPlex/Nuclear-Laser-Medicine/In-house) showed a good linearity (R2 > 0.90), but for HDV-RNA < 1000 IU/ml only Bosphore-on-InGenius, AltoStar, RealStar and Robogene showed a R2 > 0.85.
Conclusions: This study underlines heterogeneous sensitivities (inter- and intraassays), that could hamper proper HDV-RNA quantification, particularly at low viral loads. This raises the need to improve the diagnostic performance of most assays for properly identifying virological response to anti-HDV drugs.
{"title":"Comparison of diagnostic performances of HDV-RNA quantification assays used in clinical practice: Results from a national quality control multicenter study.","authors":"Romina Salpini, Lorenzo Piermatteo, Gian Paolo Caviglia, Ada Bertoli, Maurizia Rossana Brunetto, Bianca Bruzzone, Annapaola Callegaro, Cinzia Caudai, Daniela Cavallone, Luchino Chessa, Fernando Coghe, Nicola Coppola, Nunzia Cuomo, Stefano D'Anna, Mariantonietta Di Stefano, Floriana Facchetti, Claudio Farina, Donatella Ferraro, Elisa Franchin, Daniela Francisci, Silvia Galli, Anna Rosa Garbuglia, William Gennari, Valeria Ghisetti, Pietro Lampertico, Sergio Lo Caputo, Nadia Marascio, Stefano Menzo, Valeria Micheli, Grazia Anna Niro, Antonella Olivero, Pierpaolo Paba, Concetta Ilenia Palermo, Orazio Palmieri, Stefania Paolucci, Mariantonietta Pisaturo, Teresa Pollicino, Giuseppina Raffa, Teresa Santantonio, Giulia Torre, Ombretta Turriziani, Sergio Uzzau, Sara Colonia Uceda Renteria, Marialinda Vatteroni, Maurizio Zazzi, Antonio Craxì, Francesca Ceccherini-Silberstein, Valentina Svicher, Marco Arosio, Sabrina Bastianelli, Annamaria Gentile, Federica A M Giardina, Anna Gidari, Rosalba Govoni, Gabriele Ibba, Alessandro Loglio, Alessandra Lombardi, Chiara Mascarella, Fabrizio Maggi, Giovanni Matera, Chiara Mazzei, Maria Grazia Milia, Angela Quirino, Adriana Raddi, Rosetta Scioscia, Sara Tagliazucchi, Michele Totaro, Rea Valaperta","doi":"10.1016/j.jcv.2025.105850","DOIUrl":"10.1016/j.jcv.2025.105850","url":null,"abstract":"<p><strong>Introduction: </strong>A reliable quantification of hepatitis D virus (HDV) RNA is of paramount importance for monitoring patients under antiviral therapy. This quality control study compares the diagnostic performances of quantitative HDV-RNA assays used in clinical practice.</p><p><strong>Methods: </strong>Two HDV-RNA sample panels were quantified in 30 centers by RoboGene (N = 9 laboratories), EurobioPlex (N = 7), RealStar (N = 4), AltoStar (N = 1), Bosphore (N = 3), Bosphore-on-InGenius (N = 1), Dia.Pro (N = 2), Nuclear-Laser-Medicine (N = 1) and 3 in-house assays. Panel A and B comprised 8 serial dilutions of WHO/HDV standard (range: 0.5-5.0 log10 IU/ml) and 20 clinical samples (range: 0.5-6.0 log10 IU/ml), respectively. The following parameters were determined: sensitivity by 95 % LOD (limit of detection), precision by intra- and inter-run CV (coefficient of variation), accuracy by the differences between expected-observed HDV-RNA, linearity by linear regression analysis.</p><p><strong>Results: </strong>95 % LOD varied across assays and centers underlining heterogeneous sensitivities: AltoStar had the lowest 95 % LOD (3 IU/ml) followed by RealStar (10 [min-max: 3-316] IU/ml), Bosphore-on-InGenius (10 IU/ml), RoboGene (31 [3-316] IU/ml), Nuclear-Laser-Medicine (31 IU/ml) and EuroBioplex (100 [100-316] IU/ml). Moreover, 6 assays (RoboGene, EurobioPlex, RealStar, AltoStar, Nuclear-Laser-Medicine and In-house) showed <0.5 log10 IU/ml differences between expected and observed HDV-RNA for all dilutions while other assays had >1 log10 IU/ml underestimations. RealStar, Bosphore-on-InGenius and EurobioPlex had the highest precision (mean intra-run CV < 20 %). Inter-run CV was higher for all assays, with CVs < 25 % for RealStar, AltoStar, Nuclear-Laser-Medicine and EurobioPlex. Seven assays (RoboGene/AltoStar/RealStar/EurobioPlex/Nuclear-Laser-Medicine/In-house) showed a good linearity (R<sup>2</sup> > 0.90), but for HDV-RNA < 1000 IU/ml only Bosphore-on-InGenius, AltoStar, RealStar and Robogene showed a R<sup>2</sup> > 0.85.</p><p><strong>Conclusions: </strong>This study underlines heterogeneous sensitivities (inter- and intraassays), that could hamper proper HDV-RNA quantification, particularly at low viral loads. This raises the need to improve the diagnostic performance of most assays for properly identifying virological response to anti-HDV drugs.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"105850"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144816830","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}
Pub Date : 2025-10-01Epub Date: 2025-08-06DOI: 10.1016/j.jcv.2025.105853
Anja Oštrbenk, Helle Pedersen, Mario Poljak, Jesper Bonde
A key parameter for the continued success of cervical cancer screening is quality-controlled use of human papillomavirus (HPV) tests that are clinically validated according to international guidelines. The clinical accuracy for cervical screening of the Allplex HPV HR Detection (Allplex), which concurrently detects and distinguishes 12 high-risk HPV types (16,18,31,33,35,39,45,51,52,56,58,59) and HPV66 and HPV68 was assessed on SurePath samples by comparing its performance to the second-generation comparator BD Onclarity HPV assay (Onclarity). The absolute clinical sensitivity, assessed on 76 samples derived from a screening population with underlying CIN2+, of Allplex and Onclarity was 98.7 % (95 % CI, 92.9-100.0 %) and 100.0 % (95 % CI, 95.2-100.0 %), respectively, with relative sensitivity of Allplex of 0.99 (95 % CI; 0.96-1.01). The absolute clinical specificity, assessed on 801 consecutive clinician-collected cervical samples obtained from women 30 to 59 years old attending the routine Danish cervical screening program, for Allplex and Onclarity was 92.5 % (95 % CI, 90.4-94.2 %) and 92.5 % (95 % CI, 90.4-94.2 %), respectively, with relative specificity of Allplex of 1.00 (95 % CI; 0.99-1.01). With thresholds mandated by international guidelines of ≥90 % for relative clinical sensitivity (p = 0.001) and ≥98 % for relative clinical specificity (p = 0.0018), Allplex was non-inferior to Onclarity. Excellent intra- and inter-laboratory agreement of Allplex was observed, both overall (99.2 % and 99.6 %) and at the genotype level (range: 99.6-100.0 %). By fulfilling all guideline requirements for clinical sensitivity, specificity, and reproducibility, Allplex can be considered clinically validated for primary cervical screening using clinician-collected SurePath samples. With this study, Allplex also meets the criteria for a second-generation HPV comparator test.
{"title":"The Allplex HPV HR Detection assay fulfils international guideline requirements for primary cervical screening on SurePath samples and qualifies as a second-generation HPV comparator test.","authors":"Anja Oštrbenk, Helle Pedersen, Mario Poljak, Jesper Bonde","doi":"10.1016/j.jcv.2025.105853","DOIUrl":"10.1016/j.jcv.2025.105853","url":null,"abstract":"<p><p>A key parameter for the continued success of cervical cancer screening is quality-controlled use of human papillomavirus (HPV) tests that are clinically validated according to international guidelines. The clinical accuracy for cervical screening of the Allplex HPV HR Detection (Allplex), which concurrently detects and distinguishes 12 high-risk HPV types (16,18,31,33,35,39,45,51,52,56,58,59) and HPV66 and HPV68 was assessed on SurePath samples by comparing its performance to the second-generation comparator BD Onclarity HPV assay (Onclarity). The absolute clinical sensitivity, assessed on 76 samples derived from a screening population with underlying CIN2+, of Allplex and Onclarity was 98.7 % (95 % CI, 92.9-100.0 %) and 100.0 % (95 % CI, 95.2-100.0 %), respectively, with relative sensitivity of Allplex of 0.99 (95 % CI; 0.96-1.01). The absolute clinical specificity, assessed on 801 consecutive clinician-collected cervical samples obtained from women 30 to 59 years old attending the routine Danish cervical screening program, for Allplex and Onclarity was 92.5 % (95 % CI, 90.4-94.2 %) and 92.5 % (95 % CI, 90.4-94.2 %), respectively, with relative specificity of Allplex of 1.00 (95 % CI; 0.99-1.01). With thresholds mandated by international guidelines of ≥90 % for relative clinical sensitivity (p = 0.001) and ≥98 % for relative clinical specificity (p = 0.0018), Allplex was non-inferior to Onclarity. Excellent intra- and inter-laboratory agreement of Allplex was observed, both overall (99.2 % and 99.6 %) and at the genotype level (range: 99.6-100.0 %). By fulfilling all guideline requirements for clinical sensitivity, specificity, and reproducibility, Allplex can be considered clinically validated for primary cervical screening using clinician-collected SurePath samples. With this study, Allplex also meets the criteria for a second-generation HPV comparator test.</p>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"105853"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144804233","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}
To evaluate the clinical performance of an extended HPV genotyping assay for anal cancer screening in high-risk populations and investigate the prevalence of high-risk HPV (HR-HPV) genotypes in patients diagnosed with anal intraepithelial neoplasia grade 2 or worse (AIN2+).
Study design
A prospective cohort study was conducted at the European Institute of Oncology, Milan, Italy, from September 2022 to September 2024. A total of 202 high-risk individuals were enrolled. Anal samples were collected using a brush in ThinPrep PreservCyt from all subjects for HPV testing and genotyping; cytology was performed unless histology was already available. Associations between variables and sex were tested. Sensitivity, specificity, and predictive values for AIN2+ relative to HPV status were calculated. HR-HPV genotype prevalence was analysed in the overall population and among AIN2+ cases.
Results
The final study population comprised 192 subjects due to 10 invalid samples. No significant associations were found between patient characteristics and sex. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 87.7 % (95 % CI: 76.3–94.9), 72.6 % (95 % CI: 64.3–79.9), 57.5 % (95 % CI: 46.4–68.0), and 93.3 % (95 % CI: 86.7–97.3), respectively. Approximately 30 % of subjects were diagnosed with AIN2+. HR-HPV genotype distribution was similar between women and men. HPV16 was predominant in AIN2+ cases (>70 %), followed by the 33/58 and 56/59/66 pools in women.
Conclusions
Extended HPV genotyping may support anal cancer screening strategies by providing a potential standalone tool for both screening and triage. Further studies are needed to confirm these findings in larger cohorts.
{"title":"Clinical performance of the BD Onclarity™ HPV extended genotyping assay for anal cancer screening: a prospective pilot study","authors":"Anna Daniela Iacobone , Fabio Bottari , Davide Radice , Silvia Martella , Pietro Soru , Cristian Mauro , Chiara Scacchi , Clementina Di Tonno , Rita Passerini , Cristina Trovato","doi":"10.1016/j.jcv.2025.105846","DOIUrl":"10.1016/j.jcv.2025.105846","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate the clinical performance of an extended HPV genotyping assay for anal cancer screening in high-risk populations and investigate the prevalence of high-risk HPV (HR-HPV) genotypes in patients diagnosed with anal intraepithelial neoplasia grade 2 or worse (AIN2+).</div></div><div><h3>Study design</h3><div>A prospective cohort study was conducted at the European Institute of Oncology, Milan, Italy, from September 2022 to September 2024. A total of 202 high-risk individuals were enrolled. Anal samples were collected using a brush in ThinPrep PreservCyt from all subjects for HPV testing and genotyping; cytology was performed unless histology was already available. Associations between variables and sex were tested. Sensitivity, specificity, and predictive values for AIN2+ relative to HPV status were calculated. HR-HPV genotype prevalence was analysed in the overall population and among AIN2+ cases.</div></div><div><h3>Results</h3><div>The final study population comprised 192 subjects due to 10 invalid samples. No significant associations were found between patient characteristics and sex. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 87.7 % (95 % CI: 76.3–94.9), 72.6 % (95 % CI: 64.3–79.9), 57.5 % (95 % CI: 46.4–68.0), and 93.3 % (95 % CI: 86.7–97.3), respectively. Approximately 30 % of subjects were diagnosed with AIN2+. HR-HPV genotype distribution was similar between women and men. HPV16 was predominant in AIN2+ cases (>70 %), followed by the 33/58 and 56/59/66 pools in women.</div></div><div><h3>Conclusions</h3><div>Extended HPV genotyping may support anal cancer screening strategies by providing a potential standalone tool for both screening and triage. Further studies are needed to confirm these findings in larger cohorts.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"Article 105846"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144771306","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}
Pub Date : 2025-10-01Epub Date: 2025-07-28DOI: 10.1016/j.jcv.2025.105845
Keith Farrugia , Zain Khalil , Adriana van de Guchte , Bremy Alburquerque , Daniel Floda , PSP Study Group , Komal Srivastava , Luz H. Patiño , Juan David Ramirez , Alberto E. Paniz-Mondolfi , Emilia Mia Sordillo , Viviana Simon , Ana S. Gonzalez-Reiche , Harm van Bakel
Background
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern (VOCs) are characterized by distinct mutations in the S1 domain of the viral spike protein. This domain encompasses the N-terminal domain, the receptor-binding domain, and part of the cleavage site region. While mutations in other genomic regions of SARS-CoV-2 can impact VOC potential, the S1 domain holds particular importance for identifying variants and assessing antigenic evolution and immune escape potential.
Methods
We describe a rapid high-throughput sequencing-based assay, SpikeID, for the unbiased detection and identification of SARS-CoV-2 variants based on spike S1 amplicon sequencing. We benchmarked the SpikeID assay against Illumina whole-genome sequencing across 622 clinical biospecimens, representing lineages that circulated globally from October 2021 to January 2024.
Results
SpikeID unambiguously detected 100 % of WHO-designated VOCs and identified PANGO lineages circulating at ≥1 % prevalence in the New York City (NYC) area with 93 % accuracy in comparison to whole-genome sequencing. This reduction in accuracy was largely due to PANGO lineages that are only distinguishable by mutations outside the S1 domain.
Conclusions
We demonstrate the utility and scalability of the SpikeID assay during the emergence and subsequent surge of Omicron and Omicron-derived lineages in New York City, and show that our approach enables cost-effective, reliable, and near-real-time detection of emerging lineages.
{"title":"SpikeID: Rapid and unbiased identification of SARS-CoV-2 variants by spike sequencing","authors":"Keith Farrugia , Zain Khalil , Adriana van de Guchte , Bremy Alburquerque , Daniel Floda , PSP Study Group , Komal Srivastava , Luz H. Patiño , Juan David Ramirez , Alberto E. Paniz-Mondolfi , Emilia Mia Sordillo , Viviana Simon , Ana S. Gonzalez-Reiche , Harm van Bakel","doi":"10.1016/j.jcv.2025.105845","DOIUrl":"10.1016/j.jcv.2025.105845","url":null,"abstract":"<div><h3>Background</h3><div>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern (VOCs) are characterized by distinct mutations in the S1 domain of the viral spike protein. This domain encompasses the N-terminal domain, the receptor-binding domain, and part of the cleavage site region. While mutations in other genomic regions of SARS-CoV-2 can impact VOC potential, the S1 domain holds particular importance for identifying variants and assessing antigenic evolution and immune escape potential.</div></div><div><h3>Methods</h3><div>We describe a rapid high-throughput sequencing-based assay, SpikeID, for the unbiased detection and identification of SARS-CoV-2 variants based on spike S1 amplicon sequencing. We benchmarked the SpikeID assay against Illumina whole-genome sequencing across 622 clinical biospecimens, representing lineages that circulated globally from October 2021 to January 2024.</div></div><div><h3>Results</h3><div>SpikeID unambiguously detected 100 % of WHO-designated VOCs and identified PANGO lineages circulating at ≥1 % prevalence in the New York City (NYC) area with 93 % accuracy in comparison to whole-genome sequencing. This reduction in accuracy was largely due to PANGO lineages that are only distinguishable by mutations outside the S1 domain.</div></div><div><h3>Conclusions</h3><div>We demonstrate the utility and scalability of the SpikeID assay during the emergence and subsequent surge of Omicron and Omicron-derived lineages in New York City, and show that our approach enables cost-effective, reliable, and near-real-time detection of emerging lineages.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"Article 105845"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144779932","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}
Pub Date : 2025-10-01Epub Date: 2025-07-15DOI: 10.1016/j.jcv.2025.105835
Debarpan Dhar , Anjana Sasidharan , Katelyn E. VanDonge , Brian Lee , Maria Deza-Leon , Christopher J. Harrison , Dithi Banerjee , Rangaraj Selvarangan
Background
Parechovirus-A5 (PeV-A5) blood and central nervous system (CNS) infections are rare in the United States of America (USA) and globally. We report an emergence of PeV-A5 infections among infants in Kansas City, Missouri, in 2024.
Methods
Cerebrospinal fluid (CSF) and blood samples from infants were tested for Parechovirus-A (PeV-A) in 2024 as a part of standard of care at Children's Mercy Kansas City (CM-KC). PeV-A testing included a two-step reverse transcriptase-polymerase chain reaction, and genotyping was conducted using Sanger sequencing. We analyzed the amino acid sequences and phylogeny of the 2024 PeV-A viruses and described the clinical characteristics of PeV-A infected infants.
Results
Among 211 CSF and 46 blood samples from 248 patients, 10 (4 %) PeV-A infected patients were detected (8 CSF, 2 blood). Genotyping was successful for viruses from 9 PeV-A infected patients, with 8 identified as PeV-A5 (6 CSF, 2 blood) and 1 as PeV-A4 (CSF). PeV-A5 viral sequences from CM-KC clustered with other known PeV-A5 sequences, being most similar (>97 %) to a PeV-A5 viral sequence from Sapporo City, Japan, in 2018. PeV-A5 detections from CM-KC occurred with a summer-fall seasonality. All 8 PeV-A5 infected patients had symptoms of rash with less irritability and lower maximum temperature when compared to previous PeV-A3 and PeV-A4 infected patients at CM-KC.
Conclusions
PeV-A5 emerged as the predominant PeV-A genotype detected from sterile sites (CSF, blood) in infants in Kansas City, Missouri in 2024, representing the highest number of PeV-A5 systemic illness in infants in the USA within a year.
背景：在美国和全球范围内，小儿麻痹病毒- a5 （PeV-A5）血液和中枢神经系统（CNS）感染是罕见的。我们报告了2024年密苏里州堪萨斯城婴儿中出现的PeV-A5感染。方法作为堪萨斯城儿童慈善医院（CM-KC）护理标准的一部分，于2024年对婴儿脑脊液（CSF）和血液样本进行parechoovirus - a （PeV-A）检测。PeV-A检测包括两步逆转录聚合酶链反应，并使用Sanger测序进行基因分型。我们分析了2024株PeV-A病毒的氨基酸序列和系统发育，并描述了PeV-A感染婴儿的临床特征。结果248例患者的211份脑脊液和46份血液标本中，检出PeV-A感染者10例（4%），其中脑脊液8例，血液2例。9例PeV-A感染患者的病毒分型成功，其中8例为PeV-A5（6例脑脊液，2例血液），1例为PeV-A4（脑脊液）。CM-KC的PeV-A5病毒序列与其他已知的PeV-A5序列聚类，与2018年日本札幌市的PeV-A5病毒序列最相似（> 97%）。CM-KC的PeV-A5检测呈夏秋季季节性。8例PeV-A5感染患者在CM-KC与先前的PeV-A3和PeV-A4感染患者相比，均出现皮疹症状，易激惹性减轻，最高体温降低。结论2024年在美国密苏里州堪萨斯城的婴儿无菌部位（CSF、血液）检测到的PeV-A5是主要的PeV-A基因型，代表了一年内美国婴儿中PeV-A5全系统疾病的最高数量。
{"title":"Emergence of Parechovirus-A5 central nervous system infections in children from Kansas City, Missouri, USA","authors":"Debarpan Dhar , Anjana Sasidharan , Katelyn E. VanDonge , Brian Lee , Maria Deza-Leon , Christopher J. Harrison , Dithi Banerjee , Rangaraj Selvarangan","doi":"10.1016/j.jcv.2025.105835","DOIUrl":"10.1016/j.jcv.2025.105835","url":null,"abstract":"<div><h3>Background</h3><div>Parechovirus-A5 (PeV-A5) blood and central nervous system (CNS) infections are rare in the United States of America (USA) and globally. We report an emergence of PeV-A5 infections among infants in Kansas City, Missouri, in 2024.</div></div><div><h3>Methods</h3><div>Cerebrospinal fluid (CSF) and blood samples from infants were tested for Parechovirus-A (PeV-A) in 2024 as a part of standard of care at Children's Mercy Kansas City (CM-KC). PeV-A testing included a two-step reverse transcriptase-polymerase chain reaction, and genotyping was conducted using Sanger sequencing. We analyzed the amino acid sequences and phylogeny of the 2024 PeV-A viruses and described the clinical characteristics of PeV-A infected infants.</div></div><div><h3>Results</h3><div>Among 211 CSF and 46 blood samples from 248 patients, 10 (4 %) PeV-A infected patients were detected (8 CSF, 2 blood). Genotyping was successful for viruses from 9 PeV-A infected patients, with 8 identified as PeV-A5 (6 CSF, 2 blood) and 1 as PeV-A4 (CSF). PeV-A5 viral sequences from CM-KC clustered with other known PeV-A5 sequences, being most similar (>97 %) to a PeV-A5 viral sequence from Sapporo City, Japan, in 2018. PeV-A5 detections from CM-KC occurred with a summer-fall seasonality. All 8 PeV-A5 infected patients had symptoms of rash with less irritability and lower maximum temperature when compared to previous PeV-A3 and PeV-A4 infected patients at CM-KC.</div></div><div><h3>Conclusions</h3><div>PeV-A5 emerged as the predominant PeV-A genotype detected from sterile sites (CSF, blood) in infants in Kansas City, Missouri in 2024, representing the highest number of PeV-A5 systemic illness in infants in the USA within a year.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"Article 105835"},"PeriodicalIF":4.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144703721","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}
Pub Date : 2025-10-01Epub Date: 2025-08-07DOI: 10.1016/j.jcv.2025.105851
Erin McElvania , Deepa Rao , Alexander L. Greninger , Glenn Harnett , Allan Larcena , Amrish Patel , Brian Webster , Christina Ulen , Dallas F. Green , Dana King , Deepesh Rubin Patel , Imad Jandali , Jane Gibson , Jennifer Killion , Jibran Atwi , Kelly R. Bergmann , Lance Slade , Mary Allen Staat , Matthew Faron , Megan Washington , Xiaohong Liu
Background
Respiratory viruses are responsible for millions of healthcare visits annually. The unpredictable periodicity of Coronavirus disease 2019 and seasonal patterns of influenza and respiratory syncytial virus result in concurrent circulation of these viruses with non-specific and overlapping clinical symptoms.
Study design
This study evaluated the Cepheid Xpert Xpress CoV-2/Flu/RSV plus test using 3011 nasopharyngeal swab (NPS) and 2943 anterior nasal (NS) specimens. The assay was evaluated in CLIA-accredited (CA) laboratories with laboratory trained operators and CLIA-waived (CW) settings with non-laboratory personnel. Results were compared to the BioFire Respiratory Panel 2.1 for SARS-CoV-2 and Hologic Panther Fusion Flu A/B/RSV for influenza A, influenza B, and RSV. Cepheid Xpert Xpress CoV-2/Flu/RSV plus testing of NPS and NS specimens had high positive and negative agreement with reference testing.
Results
Overall agreement for NPS was 98.8 %, 99.1 %, 99.9 %, and 100 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. For NS, overall agreement was 98.7 %, 99.3 %, 99.9 %, and 99.9 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. Specimen testing performed at CA and CW locations also had high positive and negative agreement with reference testing. Overall agreement for CA testing was 97.7 %, 99.6 %, 100 %, and 100 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. For CW testing, overall agreement was 98.8 %, 99.0 %, 99.9 %, and 99.9 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively.
Conclusions
This study demonstrates that Xpert Xpress CoV-2/Flu/RSV plus provides rapid and accurate results from NPS and NS specimens in CA and CW testing facilities regardless of staff experience with molecular testing.
{"title":"Evaluation of Cepheid Xpert Xpress CoV-2/Flu/RSV plus for nasal and nasopharyngeal specimens tested in CLIA-accredited and CLIA-waived settings","authors":"Erin McElvania , Deepa Rao , Alexander L. Greninger , Glenn Harnett , Allan Larcena , Amrish Patel , Brian Webster , Christina Ulen , Dallas F. Green , Dana King , Deepesh Rubin Patel , Imad Jandali , Jane Gibson , Jennifer Killion , Jibran Atwi , Kelly R. Bergmann , Lance Slade , Mary Allen Staat , Matthew Faron , Megan Washington , Xiaohong Liu","doi":"10.1016/j.jcv.2025.105851","DOIUrl":"10.1016/j.jcv.2025.105851","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory viruses are responsible for millions of healthcare visits annually. The unpredictable periodicity of Coronavirus disease 2019 and seasonal patterns of influenza and respiratory syncytial virus result in concurrent circulation of these viruses with non-specific and overlapping clinical symptoms.</div></div><div><h3>Study design</h3><div>This study evaluated the Cepheid Xpert Xpress CoV-2/Flu/RSV plus test using 3011 nasopharyngeal swab (NPS) and 2943 anterior nasal (NS) specimens. The assay was evaluated in CLIA-accredited (CA) laboratories with laboratory trained operators and CLIA-waived (CW) settings with non-laboratory personnel. Results were compared to the BioFire Respiratory Panel 2.1 for SARS-CoV-2 and Hologic Panther Fusion Flu A/B/RSV for influenza A, influenza B, and RSV. Cepheid Xpert Xpress CoV-2/Flu/RSV plus testing of NPS and NS specimens had high positive and negative agreement with reference testing.</div></div><div><h3>Results</h3><div>Overall agreement for NPS was 98.8 %, 99.1 %, 99.9 %, and 100 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. For NS, overall agreement was 98.7 %, 99.3 %, 99.9 %, and 99.9 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. Specimen testing performed at CA and CW locations also had high positive and negative agreement with reference testing. Overall agreement for CA testing was 97.7 %, 99.6 %, 100 %, and 100 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively. For CW testing, overall agreement was 98.8 %, 99.0 %, 99.9 %, and 99.9 % for SARS-CoV-2, influenza A, influenza B, and RSV, respectively.</div></div><div><h3>Conclusions</h3><div>This study demonstrates that Xpert Xpress CoV-2/Flu/RSV plus provides rapid and accurate results from NPS and NS specimens in CA and CW testing facilities regardless of staff experience with molecular testing.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"180 ","pages":"Article 105851"},"PeriodicalIF":3.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144840769","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}
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