The study of Human Metapneumovirus (HMPV) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have critical importance due to their significant impact on the respiratory system and public health worldwide. Although they have different transmission dynamics, disease severity, and immune responses, both viruses are major causes of respiratory disorders. Focusing on their structural features, clinical symptoms, and epidemiological trends, this paper seeks to find the parallels and contrasts between HMPV and SARS-CoV-2. Although both viruses are RNA-based and cause acute respiratory illnesses, SARS-CoV-2 has caused a worldwide pandemic with high rates of transmission and severe consequences including great morbidity and mortality. While HMPV mostly causes minor respiratory problems, it still places a significant burden on vulnerable groups, especially children, the elderly, and immunocompromised people. Important variations noted include HMPV shows more confined seasonal outbreaks while SARS-CoV-2′s increased transmission rate and rapid evolution lead to the emergence of new variants.
Several factors currently limit HMPV's potential to cause pandemics. Its relatively low basic reproduction number (R0), lack of a non-human host that reduces opportunities for it to jump from animal reservoirs, non-segmented genome that prevents reassortment, and its low evolutionary rate. Moreover, HMPV is not an emerging virus, and has been circulating in humans for several decades. Therefore, a basic level of immunity already exists.
{"title":"Divergent origins, divergent pandemic potential: A comparative analysis of HMPV and SARS-CoV-2","authors":"Fateme Mozaffari , Setayesh Fakhari , Ameneh Elikaei , Zahra Ahmadi , Behrokh Farahmand , Ali Maleki","doi":"10.1016/j.jcvp.2025.100223","DOIUrl":"10.1016/j.jcvp.2025.100223","url":null,"abstract":"<div><div>The study of Human Metapneumovirus (HMPV) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have critical importance due to their significant impact on the respiratory system and public health worldwide. Although they have different transmission dynamics, disease severity, and immune responses, both viruses are major causes of respiratory disorders. Focusing on their structural features, clinical symptoms, and epidemiological trends, this paper seeks to find the parallels and contrasts between HMPV and SARS-CoV-2. Although both viruses are RNA-based and cause acute respiratory illnesses, SARS-CoV-2 has caused a worldwide pandemic with high rates of transmission and severe consequences including great morbidity and mortality. While HMPV mostly causes minor respiratory problems, it still places a significant burden on vulnerable groups, especially children, the elderly, and immunocompromised people. Important variations noted include HMPV shows more confined seasonal outbreaks while SARS-CoV-2′s increased transmission rate and rapid evolution lead to the emergence of new variants.</div><div>Several factors currently limit HMPV's potential to cause pandemics. Its relatively low basic reproduction number (R0), lack of a non-human host that reduces opportunities for it to jump from animal reservoirs, non-segmented genome that prevents reassortment, and its low evolutionary rate. Moreover, HMPV is not an emerging virus, and has been circulating in humans for several decades. Therefore, a basic level of immunity already exists.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 3","pages":"Article 100223"},"PeriodicalIF":1.6,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144331275","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}
Pub Date : 2025-06-12DOI: 10.1016/j.jcvp.2025.100221
Tracy McMillen , Eleanor Powell , Krupa Jani , Marco R. Scipione , Susan K. Seo , N. Esther Babady
Purpose
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.
Methods
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.
Results
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 (p < 0.0274).
Conclusion
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.
目的：脑炎和脑炎是需要及时干预的医疗紧急情况。BioFire脑膜炎/脑炎（M/E）面板（BioFire®Diagnostics, Salt Lake City， UT）被美国食品和药物管理局（FDA）批准用于直接检测脑脊液（CSF）上的14种病原体。已经在一些患者群体中评估了M/E小组对抗病毒和病毒检测使用的影响，但癌症患者的数据仍然有限。在这项研究中，我们评估了M/E小组在实施一年内对癌症患者群体中阿昔洛韦和单链病毒PCR检测使用的影响。方法采用干预前后对照研究。从实验室和临床信息系统中提取干预前一年和干预后一年检测的患者数据。结果研究期间共检测476例患者（干预前207例，干预后269例）。干预后，靶向病毒检测次数减少了64.9%(703对247个pcr)，接受阿昔洛韦治疗的患者总数减少了29.1%（82例对45例），治疗持续时间从干预后的7.33天减少到4.47天(p <；0.0274)。结论M/E小组的实施有助于减少进行的单复数PCR检测的数量，减少我们癌症患者群体中阿昔洛韦治疗的使用和持续时间。
{"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 , Eleanor Powell , Krupa Jani , Marco R. Scipione , Susan K. Seo , 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> < 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":"2025-06-12","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}
Pub Date : 2025-06-10DOI: 10.1016/j.jcvp.2025.100222
Zainah M. Al Shahrani, Yahya I. Alnshbah, Safaa A. Fallatah, Tabish Humayun, Ghazail M. Albeshi, Nawal M. Alanazi, Fayze Z. Aldalbehi, Eman A. Barnawi, Nawaf M. Almatrafi, Dalal H. Almutairi, Alhanouf A. Aldarami, Rayed A. Alasiri, Nasser H. Alshanbari, Khalid H. Alanazi, Hala M. Roushdy
Background
Although COVID-19 vaccinations prevent infection, certain cases have been documented even after vaccination. This has raised questions regarding their safety and effectiveness.
Aim
Evaluating the efficacy of COVID-19 vaccines among healthcare workers in Saudi Arabia and assessing the severity of post-vaccination infection.
Subject and Methods
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.
Results
The overall mean COVID-19 positivity rates among the HCWs were higher following vaccination and were found to be 52.88 % (n = 65,968) compared to 47.12 % (n = 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 (p > 0.05).
Conclusion
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.
{"title":"Efficacy of COVID-19 vaccines among healthcare workers in the Kingdom of Saudi Arabia","authors":"Zainah M. Al Shahrani, Yahya I. Alnshbah, Safaa A. Fallatah, Tabish Humayun, Ghazail M. Albeshi, Nawal M. Alanazi, Fayze Z. Aldalbehi, Eman A. Barnawi, Nawaf M. Almatrafi, Dalal H. Almutairi, Alhanouf A. Aldarami, Rayed A. Alasiri, Nasser H. Alshanbari, Khalid H. Alanazi, 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> > 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":"2025-06-10","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}
Pub Date : 2025-06-09DOI: 10.1016/j.jcvp.2025.100219
Howard James Shi, Joshua David Shi, Zhijie Li, Tim Hao Shi
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.
{"title":"Development of a novel point-of-care device detecting monkeypox virus using lyophilized microspheres and lateral flow strips","authors":"Howard James Shi, Joshua David Shi, Zhijie Li, 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":"2025-06-09","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}
Pub Date : 2025-05-22DOI: 10.1016/j.jcvp.2025.100217
Eloina Faye S. Gampoy , Gielenny M. Salem , Jedhan U. Galula , Fresthel Monica M. Climacosa , Leslie Michelle M. Dalmacio , Day-Yu Chao
Objectives
The immune response to SARS-CoV-2 infection, particularly the dynamics of antigen-specific and isotype-specific antibodies, is critical for understanding disease progression and outcomes. This study characterizes the antibody profiles and serum neutralizing capacity as well as its relationship with disease severity among COVID-19 patients from the Philippines, prior to the national COVID-19 vaccination rollout.
Methods
A total of 177 serum samples from 67 hospitalized patients with RT-PCR-confirmed COVID-19 were analyzed during the first wave of the pandemic between October 2020 to April 2021. Various antibody isotypes (IgG, IgM, and IgA) against SARS-CoV-2 S1, S2, RBD, and N proteins, as well as IgG antibodies against human ACE2, were quantified by enzyme-linked immunosorbent assay (ELISA). Serum neutralizing capacity was assessed by ACE2-RBD binding inhibition assay and pseudovirus neutralization assays. The relationship of the binding antibodies with various clinical parameters was also determined.
Results
IgG, IgM, and IgA antibody responses were associated with disease severity within two weeks of symptom onset. Notably, IgM responses positively correlated with elevated inflammatory markers, including ferritin and C-reactive protein, while IgM-N predicted in-hospital mortality. However, patient sera lacked neutralizing activity against the SARS-CoV-2 Wuhan strain. While the anti-ACE2 IgG antibodies were detected, their presence was not associated with disease severity or inflammatory responses.
Conclusions
These findings suggest that while binding antibodies are prevalent early in infection among COVID-19 patients early in the pandemic, serum neutralizing capacity remains low in the absence of vaccination. The clinical significance of detectable anit-ACE2 antibodies in COVID-19 warrants further investigation.
{"title":"SARS-CoV-2 antibody response and serum neutralizing capacity of early unvaccinated COVID-19 patients in the Philippines","authors":"Eloina Faye S. Gampoy , Gielenny M. Salem , Jedhan U. Galula , Fresthel Monica M. Climacosa , Leslie Michelle M. Dalmacio , Day-Yu Chao","doi":"10.1016/j.jcvp.2025.100217","DOIUrl":"10.1016/j.jcvp.2025.100217","url":null,"abstract":"<div><h3>Objectives</h3><div>The immune response to SARS-CoV-2 infection, particularly the dynamics of antigen-specific and isotype-specific antibodies, is critical for understanding disease progression and outcomes. This study characterizes the antibody profiles and serum neutralizing capacity as well as its relationship with disease severity among COVID-19 patients from the Philippines, prior to the national COVID-19 vaccination rollout.</div></div><div><h3>Methods</h3><div>A total of 177 serum samples from 67 hospitalized patients with RT-PCR-confirmed COVID-19 were analyzed during the first wave of the pandemic between October 2020 to April 2021. Various antibody isotypes (IgG, IgM, and IgA) against SARS-CoV-2 S1, S2, RBD, and N proteins, as well as IgG antibodies against human ACE2, were quantified by enzyme-linked immunosorbent assay (ELISA). Serum neutralizing capacity was assessed by ACE2-RBD binding inhibition assay and pseudovirus neutralization assays. The relationship of the binding antibodies with various clinical parameters was also determined.</div></div><div><h3>Results</h3><div>IgG, IgM, and IgA antibody responses were associated with disease severity within two weeks of symptom onset. Notably, IgM responses positively correlated with elevated inflammatory markers, including ferritin and C-reactive protein, while IgM-N predicted in-hospital mortality. However, patient sera lacked neutralizing activity against the SARS-CoV-2 Wuhan strain. While the anti-ACE2 IgG antibodies were detected, their presence was not associated with disease severity or inflammatory responses.</div></div><div><h3>Conclusions</h3><div>These findings suggest that while binding antibodies are prevalent early in infection among COVID-19 patients early in the pandemic, serum neutralizing capacity remains low in the absence of vaccination. The clinical significance of detectable anit-ACE2 antibodies in COVID-19 warrants further investigation.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 2","pages":"Article 100217"},"PeriodicalIF":1.6,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144167467","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}
Pub Date : 2025-05-17DOI: 10.1016/j.jcvp.2025.100216
Manami Yoshida , Nao Taguchi , Yi Piao , Rikisha Gupta , Jami Peters , Mazin Abdelghany , Mel Chiang , Chen-Yu Wang , Mark Berry , Hiroshi Yotsuyanagi
Aim
To describe treatment patterns and clinical outcomes in Japanese patients with diabetes mellitus (DM) hospitalized for coronavirus disease-2019 (COVID-19) treated with remdesivir (RDV).
Methods
We included data from patients aged ≥ 18 years with DM on insulin, hospitalized for moderate to severe COVID-19, and who received ≥ 1 dose of RDV between October 2021 and September 2022, using a Japanese medical claims database. All-cause mortality, progression to severe COVID-19, and hospital discharge/recovery status were evaluated up to 56 days from the index date defined as RDV initiation.
Results
The analysis included 502 patients. The mean (SD) age at index was 74.4 (12.5) years. Median (Q1–Q3) time to RDV initiation was 2.0 (1.0–3.0) days from hospital admission; median treatment duration was 5.0 (3.0–5.0) days. At index date, 36.85 % of patients had moderate I disease (hospitalized without oxygen support), 58.96 % had moderate II disease (non-invasive positive pressure ventilation, low/high-flow oxygen), and 4.18 % had severe disease (ICU admission, mechanical ventilation, or extracorporeal membrane oxygenation). Proportion of patients with all-cause mortality was 11.16 % (95 % CI, 8.54–14.24) and 13.15 % (10.32–16.42) by 28 and 56 days. At 28 days, 12.35 % (9.60–15.55) of patients had disease progression, and 68.13 % (63.85–72.19) had recovery.
Conclusion
Most patients were elderly and required oxygen support when initiating RDV. The majority of patients received RDV within 3 days of hospitalization and recovered by 28 days. The study provides insight into outcomes in Japanese COVID-19 patients with DM treated with RDV in inpatient settings.
{"title":"Patient characteristics, treatment patterns, and clinical outcomes of remdesivir in hospitalized COVID-19 patients with diabetes mellitus on insulin: A large-scale data analysis using a Japanese claims database","authors":"Manami Yoshida , Nao Taguchi , Yi Piao , Rikisha Gupta , Jami Peters , Mazin Abdelghany , Mel Chiang , Chen-Yu Wang , Mark Berry , Hiroshi Yotsuyanagi","doi":"10.1016/j.jcvp.2025.100216","DOIUrl":"10.1016/j.jcvp.2025.100216","url":null,"abstract":"<div><h3>Aim</h3><div>To describe treatment patterns and clinical outcomes in Japanese patients with diabetes mellitus (DM) hospitalized for coronavirus disease-2019 (COVID-19) treated with remdesivir (RDV).</div></div><div><h3>Methods</h3><div>We included data from patients aged ≥ 18 years with DM on insulin, hospitalized for moderate to severe COVID-19, and who received ≥ 1 dose of RDV between October 2021 and September 2022, using a Japanese medical claims database. All-cause mortality, progression to severe COVID-19, and hospital discharge/recovery status were evaluated up to 56 days from the index date defined as RDV initiation.</div></div><div><h3>Results</h3><div>The analysis included 502 patients. The mean (SD) age at index was 74.4 (12.5) years. Median (Q1–Q3) time to RDV initiation was 2.0 (1.0–3.0) days from hospital admission; median treatment duration was 5.0 (3.0–5.0) days. At index date, 36.85 % of patients had moderate I disease (hospitalized without oxygen support), 58.96 % had moderate II disease (non-invasive positive pressure ventilation, low/high-flow oxygen), and 4.18 % had severe disease (ICU admission, mechanical ventilation, or extracorporeal membrane oxygenation). Proportion of patients with all-cause mortality was 11.16 % (95 % CI, 8.54–14.24) and 13.15 % (10.32–16.42) by 28 and 56 days. At 28 days, 12.35 % (9.60–15.55) of patients had disease progression, and 68.13 % (63.85–72.19) had recovery.</div></div><div><h3>Conclusion</h3><div>Most patients were elderly and required oxygen support when initiating RDV. The majority of patients received RDV within 3 days of hospitalization and recovered by 28 days. The study provides insight into outcomes in Japanese COVID-19 patients with DM treated with RDV in inpatient settings.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 2","pages":"Article 100216"},"PeriodicalIF":1.6,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144134607","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}
Pub Date : 2025-05-16DOI: 10.1016/j.jcvp.2025.100214
Amirreza Radfar , Neda Pirbonyeh , Afagh Moattari
Background
Human papillomavirus (HPV) is the most prevalent sexually transmitted infection, with high-risk genotypes contributing to cervical and other cancers. While HPV epidemiology has been studied in Iran, comprehensive genotype distribution data remain limited for Fars province. This study examines HPV prevalence and genotype distribution to inform regional prevention strategies.
Methods
This cross-sectional study analyzed 616 samples collected from a clinical laboratory between 2021 and 2024. HPV DNA was detected using nested PCR, and genotyping was performed via reverse hybridization. Associations between HPV status, risk classification, gender, and sample collection method were statistically assessed.
Results
Overall, 56.3 % of individuals tested positive for HPV. High-risk HPV was detected in 56.6 % of positive cases, with HPV-16 (29.6 %) and HPV-18 (6.8 %) being the most common oncogenic types. Low-risk HPV-6 (35.0 %) and HPV-11 (17.1 %) were also prevalent. No significant associations were found between HPV status and age (p = 0.346), gender (p = 0.998), or sample collection method (p = 0.998).
Conclusion
The predominance of vaccine-covered HPV types underscores the need for expanded screening and targeted prevention programs in Fars province. Although demographic factors were not significantly associated with HPV status, the high burden of high-risk types necessitates stronger regional public health interventions. These findings contribute valuable epidemiological data to enhance HPV control measures and optimize vaccination policies.
{"title":"Comprehensive HPV genotyping in Fars, Iran: Molecular epidemiology and implications for prevention","authors":"Amirreza Radfar , Neda Pirbonyeh , Afagh Moattari","doi":"10.1016/j.jcvp.2025.100214","DOIUrl":"10.1016/j.jcvp.2025.100214","url":null,"abstract":"<div><h3>Background</h3><div>Human papillomavirus (HPV) is the most prevalent sexually transmitted infection, with high-risk genotypes contributing to cervical and other cancers. While HPV epidemiology has been studied in Iran, comprehensive genotype distribution data remain limited for Fars province. This study examines HPV prevalence and genotype distribution to inform regional prevention strategies.</div></div><div><h3>Methods</h3><div>This cross-sectional study analyzed 616 samples collected from a clinical laboratory between 2021 and 2024. HPV DNA was detected using nested PCR, and genotyping was performed via reverse hybridization. Associations between HPV status, risk classification, gender, and sample collection method were statistically assessed.</div></div><div><h3>Results</h3><div>Overall, 56.3 % of individuals tested positive for HPV. High-risk HPV was detected in 56.6 % of positive cases, with HPV-16 (29.6 %) and HPV-18 (6.8 %) being the most common oncogenic types. Low-risk HPV-6 (35.0 %) and HPV-11 (17.1 %) were also prevalent. No significant associations were found between HPV status and age (<em>p</em> = 0.346), gender (<em>p</em> = 0.998), or sample collection method (<em>p</em> = 0.998).</div></div><div><h3>Conclusion</h3><div>The predominance of vaccine-covered HPV types underscores the need for expanded screening and targeted prevention programs in Fars province. Although demographic factors were not significantly associated with HPV status, the high burden of high-risk types necessitates stronger regional public health interventions. These findings contribute valuable epidemiological data to enhance HPV control measures and optimize vaccination policies.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 2","pages":"Article 100214"},"PeriodicalIF":1.6,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144114943","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}
Pub Date : 2025-05-15DOI: 10.1016/j.jcvp.2025.100215
Joe M. El-Khoury , Anthony Bonito , Rachel Fonstad , Michael Anostario , Michael Quintanilla , Neil Birmingham , Amin A. Mohammad
Background & Aims
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).
Methods
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 (n = 278) from aHCV positive individuals and negative individuals at increased risk for exposure to HCV, as well as 9 commercially available HCV seroconversion panels.
Result
Repeatability and reproducibility %CVs were <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.
Conclusion
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.
{"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 , Anthony Bonito , Rachel Fonstad , Michael Anostario , Michael Quintanilla , Neil Birmingham , Amin A. Mohammad","doi":"10.1016/j.jcvp.2025.100215","DOIUrl":"10.1016/j.jcvp.2025.100215","url":null,"abstract":"<div><h3>Background & 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 <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":"2025-05-15","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}
Pub Date : 2025-04-15DOI: 10.1016/j.jcvp.2025.100212
Nicholaus P. Mnyambwa , Jinxin Gao , Alex Magesa , Edina Mgimba , Swaminathan Mahesh , Pawan Angra , Juma Kisuse , Clara Lubinza , Lawrence Mapunda , Aman Wilfred , Godfather Kimaro , George P. Judicate , Ambele Eliah , Augustino Msanga , Senkoro Mbazi , Esther Ngadaya , Mukurasi Kokuhabwa , Jackson P. Mushumbusi , Medard Beyanga , Wangeci Gatei , Sayoki Mfinanga
Background
Genomic sequences of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from Tanzania remain scarce in GISAID, thus hindering our understanding of how the pandemic evolved in the country.
Methods
We performed whole genome sequencing on SARS-CoV-2 samples collected between March 2021 and December 2022 to characterize the virus in Tanzania. Nasal and oropharyngeal swabs were collected from patients seeking health care, incoming travelers as well as from outgoing travelers undergoing pre-travel COVID-19 testing (required for flight boarding). Sample collection, and testing were coordinated by the National Public Health Laboratory.
Results
Among 515 samples, 260 (50.49 %) were from outgoing travelers, 227 (44.08 %) Covid-19 suspects seeking care, and 28 (5.44 %) incoming travelers identified at the airport. The majority of the samples came from Dar es Salaam (n = 380, 73.7 %), the country's largest city and the main port of entry. We identified 74 Pango lineages from all the samples, with Omicron 430 (83.50 %) and Delta 79 (15 %) variants being predominant. From the 380 Dar es Salaam samples, 67 Pango lineages were identified, showing both overlapping and unique lineages in each sample type.
Conclusion
Our findings reveal a dynamic circulation of SARS-CoV-2 variants over time, with Delta predominantly observed in 2021 and Omicron in 2022 in Tanzania. The temporal prevalence of the identified lineages was consistent with the global epidemiology of the virus. Sustained and expanded genomic surveillance is recommended to track and respond effectively to emerging variants.
{"title":"Genomic analysis of SARS-CoV-2 sequences obtained in Tanzania during the pandemic","authors":"Nicholaus P. Mnyambwa , Jinxin Gao , Alex Magesa , Edina Mgimba , Swaminathan Mahesh , Pawan Angra , Juma Kisuse , Clara Lubinza , Lawrence Mapunda , Aman Wilfred , Godfather Kimaro , George P. Judicate , Ambele Eliah , Augustino Msanga , Senkoro Mbazi , Esther Ngadaya , Mukurasi Kokuhabwa , Jackson P. Mushumbusi , Medard Beyanga , Wangeci Gatei , Sayoki Mfinanga","doi":"10.1016/j.jcvp.2025.100212","DOIUrl":"10.1016/j.jcvp.2025.100212","url":null,"abstract":"<div><h3>Background</h3><div>Genomic sequences of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from Tanzania remain scarce in GISAID, thus hindering our understanding of how the pandemic evolved in the country.</div></div><div><h3>Methods</h3><div>We performed whole genome sequencing on SARS-CoV-2 samples collected between March 2021 and December 2022 to characterize the virus in Tanzania. Nasal and oropharyngeal swabs were collected from patients seeking health care, incoming travelers as well as from outgoing travelers undergoing pre-travel COVID-19 testing (required for flight boarding). Sample collection, and testing were coordinated by the National Public Health Laboratory.</div></div><div><h3>Results</h3><div>Among 515 samples, 260 (50.49 %) were from outgoing travelers, 227 (44.08 %) Covid-19 suspects seeking care, and 28 (5.44 %) incoming travelers identified at the airport. The majority of the samples came from Dar es Salaam (<em>n</em> = 380, 73.7 %), the country's largest city and the main port of entry. We identified 74 Pango lineages from all the samples, with Omicron 430 (83.50 %) and Delta 79 (15 %) variants being predominant. From the 380 Dar es Salaam samples, 67 Pango lineages were identified, showing both overlapping and unique lineages in each sample type.</div></div><div><h3>Conclusion</h3><div>Our findings reveal a dynamic circulation of SARS-CoV-2 variants over time, with Delta predominantly observed in 2021 and Omicron in 2022 in Tanzania. The temporal prevalence of the identified lineages was consistent with the global epidemiology of the virus. Sustained and expanded genomic surveillance is recommended to track and respond effectively to emerging variants.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 2","pages":"Article 100212"},"PeriodicalIF":1.6,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143864808","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}
Pub Date : 2025-04-14DOI: 10.1016/j.jcvp.2025.100211
Armel Moumouni Sanou , Abdoulaye Dera , Jeoffray Diendere , Nina Mathuola Geneviève Ouattara , Eric Kyelem , Arhouna Siguina Traore , Arouna Dao , Arielle Sandra Bettina Badiel , Ina Marie Angèle Traore , Michel Kiréopori.B Gomgnimbou , Isidore Bonkoungou , Gautier Henri Ouedraogo
Tuberculosis (TB) and viral hepatitis B and C represent significant public health concerns. Co-infection with TB and hepatitis B and/or C results in significant complications, including suboptimal treatment outcomes in TB and the development of hepatitis induced by anti-TB drugs. At present, no data on these co-infections are available for Burkina Faso. This study investigates the epidemiology of these co-infections in TB patients in the Hauts-Bassins region of Burkina Faso. A cross-sectional analytical study was conducted in health facilities involved in the management of TB in the Hauts-Bassins region of Burkina Faso from October 2023 to June 2024. For each consenting TB patient, data were collected. A blood sample was obtained and analyzed for a range of infection markers (HBsAg, HBV DNA, anti-HCV antibodies, and HCV RNA) and liver enzymes (ALT and γ-GT). A total of 259 TB patients were included in the study. The mean age of the participants was 39.7 ± 15.9 years. The overall prevalence of HBsAg was 10.03 % and 3.8 % for anti-HCV. Among the HBsAg-positive samples, HBV DNA was detected in all cases, with 68.2 % exhibiting a viral load exceeding 20,000 IU/mL. Elevated ALT was observed in 19.2 % of TB/HBsAg patients and in 30.0 % of TB/anti-HCV. About γ-GT, an elavated result was observed in 46.1 % of TB/HBsAg patients and 40.0 % of TB/anti-HCV patients. The results demonstrated a high prevalence of hepatitis B and intermediate exposure to HCV in TB patients. It is thus recommended that routine screening for these diseases be considered in TB patients.
{"title":"Hepatitis B and C infection in tuberculosis patients in the Hauts Bassins region of Burkina Faso, West Africa","authors":"Armel Moumouni Sanou , Abdoulaye Dera , Jeoffray Diendere , Nina Mathuola Geneviève Ouattara , Eric Kyelem , Arhouna Siguina Traore , Arouna Dao , Arielle Sandra Bettina Badiel , Ina Marie Angèle Traore , Michel Kiréopori.B Gomgnimbou , Isidore Bonkoungou , Gautier Henri Ouedraogo","doi":"10.1016/j.jcvp.2025.100211","DOIUrl":"10.1016/j.jcvp.2025.100211","url":null,"abstract":"<div><div>Tuberculosis (TB) and viral hepatitis B and C represent significant public health concerns. Co-infection with TB and hepatitis B and/or C results in significant complications, including suboptimal treatment outcomes in TB and the development of hepatitis induced by anti-TB drugs. At present, no data on these co-infections are available for Burkina Faso. This study investigates the epidemiology of these co-infections in TB patients in the Hauts-Bassins region of Burkina Faso. A cross-sectional analytical study was conducted in health facilities involved in the management of TB in the Hauts-Bassins region of Burkina Faso from October 2023 to June 2024. For each consenting TB patient, data were collected. A blood sample was obtained and analyzed for a range of infection markers (HBsAg, HBV DNA, anti-HCV antibodies, and HCV RNA) and liver enzymes (ALT and γ-GT). A total of 259 TB patients were included in the study. The mean age of the participants was 39.7 ± 15.9 years. The overall prevalence of HBsAg was 10.03 % and 3.8 % for anti-HCV. Among the HBsAg-positive samples, HBV DNA was detected in all cases, with 68.2 % exhibiting a viral load exceeding 20,000 IU/mL. Elevated ALT was observed in 19.2 % of TB/HBsAg patients and in 30.0 % of TB/anti-HCV. About γ-GT, an elavated result was observed in 46.1 % of TB/HBsAg patients and 40.0 % of TB/anti-HCV patients. The results demonstrated a high prevalence of hepatitis B and intermediate exposure to HCV in TB patients. It is thus recommended that routine screening for these diseases be considered in TB patients.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 2","pages":"Article 100211"},"PeriodicalIF":1.6,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143848190","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}
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