Journal of clinical virology plus最新文献_第3页

Effect of recent SARS-CoV-2 infection on anti-spike protein immunoglobulin G II response after BNT162b2 vaccination 近期SARS-CoV-2感染对接种BNT162b2后抗刺突蛋白免疫球蛋白gii应答的影响

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus

Pub Date : 2025-06-19 DOI: 10.1016/j.jcvp.2025.100224

Daiki Tanno , Yasuka Hara , Yoshiyuki Sugaya , Koji Okuaki , Shuko Kobari , Mitsuki Kitabatake , Suguru Yui , Tomoo Hidaka , Masahiro Toyokawa , Yumiko Kanari , Kiwamu Nakamura , Keiji Kanemitsu

Objectives

Our hospital experienced a SARS-CoV-2 outbreak 3 months before staff vaccination was initiated. This study compared antibody responses to the first and second doses of BNT162b2 mRNA vaccine among staff with and without prior infection.

Methods

Serum anti-spike (S) protein immunoglobulin (anti-S) IgG, IgM, and anti-nuclear (N) protein IgG, IgM were measured 1 week before the first dose (baseline). Serum anti-S IgG II levels were sequentially measured at the baseline, 3 weeks after the first dose (immediately prior to the second dose), and 3 weeks and 6 months after the second dose to assess neutralization activity.

Results

Ten of the 83 staff had evidence of prior SARS-CoV-2 infection. The baseline anti-S IgG, IgG II, anti-N IgM, and anti-N IgG levels were significantly higher in those with prior infection. Three weeks after the first dose, the mean anti-S IgG II level was significantly higher in the prior-infection group (406.94 ± 163.44 AU/mL) than that in the uninfected group (40.43 ± 50.16 AU/mL; p < 0.001). Three weeks after the second dose, the mean anti-S IgG II level was significantly lower than that after the first dose in the prior-infection group (240.28 ± 81.46 AU/mL; p = 0.007), and significantly higher in the uninfected group (341.45 ± 192.75 AU/mL; p < 0.001). Six months after the second dose, the mean anti-S IgG II levels did not differ significantly between groups.

Conclusions

A single dose of BNT162b2 vaccine is sufficient to induce a peak anti-S IgG II response in recently infected individuals.

目的在工作人员接种前3个月，我院发生了SARS-CoV-2疫情。这项研究比较了有和没有感染过BNT162b2 mRNA疫苗的工作人员对第一剂和第二剂的抗体反应。方法首次给药前1周（基线）测定血清抗刺突(S)蛋白免疫球蛋白（anti-S） IgG、IgM和抗核(N)蛋白IgG、IgM。在基线、第一次给药后3周（紧接着第二次给药之前）、第二次给药后3周和6个月依次测定血清抗s IgG II水平，以评估中和活性。结果83名医务人员中有10人有SARS-CoV-2感染史。既往感染患者的基线抗s IgG、IgG II、抗n IgM和抗n IgG水平均显著升高。第一次给药后3周，既往感染组平均抗s IgG II水平（406.94±163.44 AU/mL）显著高于未感染组（40.43±50.16 AU/mL）；p & lt;0.001)。第二次给药后3周，既往感染组抗s IgGⅱ水平显著低于第一次给药后(240.28±81.46 AU/mL；p = 0.007)，未感染组明显高于对照组(341.45±192.75 AU/mL；p & lt;0.001)。第二次给药后6个月，组间平均抗s IgG II水平无显著差异。结论单剂BNT162b2疫苗足以在近期感染的个体中诱导抗s IgG II应答高峰。

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引用次数: 0

Characteristics and outcomes of HBV-infected patients with HBsAg and anti- HBs coexistence 乙型肝炎病毒感染患者HBsAg与抗hbbs共存的特点及预后

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus

Pub Date : 2025-06-14 DOI: 10.1016/j.jcvp.2025.100220

Nguyen Thi Cam Huong , Pham Thi Hai Men , Brian Thanh Do , Hoa Pham Thi Le

Background

The coexistence of HBsAg and anti-HBs is a unique detection in chronic HBV-infected patients. This serological status has not been reported in Vietnamese cases.

Objectives

description of HBV viral markers, activity of hepatitis, and progression of HBV-infected patients with HBsAg and anti-HBs coexistence over a six-month follow-up period and define related factors to HBsAg seroclearance.

Method

cross-sectional descriptive study with a six-month follow-up on patients who tested positive for HBsAg and anti-HBs simultaneously at the Liver Clinic nit, Hospital for Tropical Diseases, Vietnam, from 12/2018 to 12/2019.

Result

122 patients with coexistence of HBsAg and anti-HBs were included. 50.8 % were male, with median age of 42 (30-53). The median of ALT was 34 (24-66) U/L, 24.6 % had chronic hepatitis, 32 % had positive HBeAg, median of HBsAg was 1.76 ((-0.25) – (2.87)) log IU/mL, median of anti-HBs was 50 (24-99) mIU/mL, median of HBVDNA was 3.45 (1.46-6.55) log copies/mL. Eighty-four patients were confirmed chronic HBV infection with anti-HBs coexistence (68.9 %), 26.2 % loss HBsAg, and 6 cases (4.9 %) loss anti-HBs, as chronic HBV infection. Without chronic hepatitis, HBsAg <100 S/CO, high anti-HBs, low HBsAg quantification lower 3 log IU/mL, HBeAg negative, HBV DNA lower 1.7 log copies/mL related to HBsAg seroclearance.

Conclusion

The coexistence of HBsAg and anti-HBs occurs in both HBeAg-negative and HBeAg-positive patients. Most cases had high viral load, and one-fourth of cases had chronic liver diseases. HBsAg loss occurred in 26.2 % of cases and related to chronic liver disease, low HBsAg, high anti-HBs, and low HBV DNA.

背景HBsAg和anti-HBs共存是慢性hbv感染患者的独特检测结果。这种血清学状况尚未在越南病例中报告。目的描述HBV病毒标志物、肝炎活动性、HBV感染患者伴HBsAg和抗hbs共存的进展情况，并确定影响HBsAg血清清除率的相关因素。方法横断面描述性研究，对2018年12月至2019年12月在越南热带病医院肝脏门诊同时检测HBsAg和anti-HBs阳性的患者进行为期6个月的随访。结果共纳入122例HBsAg和anti-HBs共存的患者。50.8%为男性，中位年龄42岁（30-53岁）。ALT中位数为34 (24-66)U/L，慢性肝炎24.6%，HBeAg阳性32%，HBsAg中位数为1.76 (-0.25)- (2.87)log IU/mL， anti-HBs中位数为50 (24-99)mIU/mL， HBVDNA中位数为3.45 (1.46-6.55)log copies/mL。确诊慢性HBV感染84例（68.9%）存在抗- hbs共存，HBsAg丢失26.2%，抗- hbs丢失6例（4.9%）为慢性HBV感染。无慢性肝炎，HBsAg <100 S/CO，高抗- hbs，低HBsAg定量低3 log IU/mL， HBeAg阴性，HBV DNA低1.7 log拷贝/mL，与HBsAg血清清除率相关。结论hbeag阴性和hbeag阳性患者均存在HBsAg和anti-HBs共存的情况。大多数病例病毒载量高，四分之一的病例有慢性肝病。26.2%的病例发生HBsAg丢失，与慢性肝病、低HBsAg、高抗- hbs和低HBV DNA有关。

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引用次数: 0

Divergent origins, divergent pandemic potential: A comparative analysis of HMPV and SARS-CoV-2 不同的起源，不同的大流行潜力：HMPV和SARS-CoV-2的比较分析

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus

Pub Date : 2025-06-12 DOI: 10.1016/j.jcvp.2025.100223

Fateme Mozaffari , Setayesh Fakhari , Ameneh Elikaei , Zahra Ahmadi , Behrokh Farahmand , Ali Maleki

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.

人偏肺病毒（HMPV）和严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）的研究对全球呼吸系统和公共卫生产生重大影响，因此具有至关重要的意义。尽管它们具有不同的传播动态、疾病严重程度和免疫反应，但这两种病毒都是导致呼吸系统疾病的主要原因。本文从HMPV和SARS-CoV-2的结构特征、临床症状和流行病学趋势等方面进行对比分析。尽管这两种病毒都是以rna为基础并引起急性呼吸道疾病，但SARS-CoV-2已引起全球大流行，传播率高，后果严重，包括发病率和死亡率高。虽然人乳头状瘤病毒主要引起轻微的呼吸问题，但它仍然给弱势群体，特别是儿童、老年人和免疫功能低下的人造成重大负担。注意到的重要变异包括HMPV表现出更有限的季节性暴发，而SARS-CoV-2的传播率增加和快速进化导致新变种的出现。目前有几个因素限制了HMPV引起大流行的可能性。它的基本繁殖数（R0）相对较低，缺乏非人类宿主，减少了从动物宿主跳跃的机会，非片段基因组防止了重组，并且其进化速度较低。此外，HMPV不是一种新出现的病毒，已经在人类中传播了几十年。因此，已经存在基本的免疫水平。

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引用次数: 0

Decrease in SinglePlex Viral PCRs Use and acyclovir utilization following implementation of The BioFire Meningitis/Encephalitis Panel at A Tertiary Care Cancer Center 在三级保健癌症中心实施BioFire脑膜炎/脑炎小组后，单链病毒pcr使用和阿昔洛韦使用的减少

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus

Pub Date : 2025-06-12 DOI: 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。

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引用次数: 0

Efficacy of COVID-19 vaccines among healthcare workers in the Kingdom of Saudi Arabia 沙特阿拉伯王国卫生保健工作者COVID-19疫苗的有效性

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus

Pub Date : 2025-06-10 DOI: 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.

虽然COVID-19疫苗可以预防感染，但即使在接种疫苗后仍有记录的某些病例。这引起了人们对其安全性和有效性的质疑。目的评估沙特阿拉伯医护人员COVID-19疫苗的有效性，并评估疫苗接种后感染的严重程度。对象与方法采用横断面设计，纳入2020年3月至2022年3月期间pcr确诊的COVID-19感染的124,742名医护人员（HCWs）。他们根据接种情况分为两组：接种前组和接种后组。收集的数据来自以下医院（卫生部、政府非卫生部和私立医院）。采用SPSS 25进行统计分析。结果接种疫苗后，卫生保健工作者COVID-19总体平均阳性率为52.88% (n = 65,968)，高于接种前组的47.12% （n = 58,774）。接种疫苗后组病死率和ICU住院率（分别为36.5%和40.9%）明显低于接种疫苗前组（分别为63.5%和59.1%）。治愈率由接种前的47.0%显著提高到接种后的53.0%。性别、国籍、职称、医院类别和疫苗类型均与接种疫苗后感染风险显著升高相关(p >；0.05)。结论接种疫苗的卫生保健人员仍有感染易感，应指导其采取一切必要的感染控制措施，以避免未来的COVID-19大流行。对私营部门进行严格监督对于对私营医疗保健环境中的感染控制政策进行重点审计和评估至关重要。

{"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}

引用次数: 0

Development of a novel point-of-care device detecting monkeypox virus using lyophilized microspheres and lateral flow strips 使用冻干微球和侧流条检测猴痘病毒的新型即时护理设备的开发

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus

Pub Date : 2025-06-09 DOI: 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.

实时荧光定量PCR作为检测猴痘病毒（MPXV）的金标准已被应用于临床诊断。然而，为了更好地预防痘病的传播，特别是在没有聚合酶链反应设备的地区，迫切需要快速和自我管理的医疗诊断设备。因此，我们尝试采用环介导等温扩增（LAMP）方法检测m痘，该方法涉及冻干微球，并通过颜色变化和侧流免疫测定条读取结果。我们首先测试了LAMP实验的最佳温度，发现65°C是最佳的结果。在此温度下，我们测试了针对MPXV基因不同区域的三种不同引物组，发现F3L-1引物优于其他引物，每次反应的检测限为70个基因组拷贝。令人惊讶的是，在F3L-1组中添加另一个引物组仅将每次反应的LoD降低到60个基因组拷贝。对于干扰试验，我们选择了通常应用于或在患者皮肤上发现的物质和/或微生物，并表明它们在指定浓度下都不会干扰测试结果。最后，我们测试了临床收集的含有MPXVs的人类皮肤拭子，并证明我们的检测方法在1倍、2倍、3倍和5倍LoD下都能很好地处理这些样品。基于这些发现，我们提出了一种医疗设备，可以在传统PCR设备不可用的地区用作护理点解决方案。

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引用次数: 0

SARS-CoV-2 antibody response and serum neutralizing capacity of early unvaccinated COVID-19 patients in the Philippines 菲律宾早期未接种COVID-19患者的SARS-CoV-2抗体反应和血清中和能力

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus

Pub Date : 2025-05-22 DOI: 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.

对SARS-CoV-2感染的免疫反应，特别是抗原特异性和同型特异性抗体的动态，对于了解疾病进展和结局至关重要。本研究描述了在全国COVID-19疫苗接种之前，菲律宾COVID-19患者的抗体谱和血清中和能力及其与疾病严重程度的关系。方法对2020年10月至2021年4月第一波疫情期间67例经rt - pcr确诊的住院患者177份血清样本进行分析。采用酶联免疫吸附试验（ELISA）定量检测针对SARS-CoV-2 S1、S2、RBD和N蛋白的各种抗体同型（IgG、IgM和IgA）以及针对人ACE2的IgG抗体。采用ACE2-RBD结合抑制试验和假病毒中和试验评估血清中和能力。结合抗体与各种临床参数的关系也被确定。结果igg、IgM和IgA抗体反应与症状出现两周内疾病严重程度相关。值得注意的是，IgM反应与炎症标志物升高呈正相关，包括铁蛋白和c反应蛋白，而IgM- n预测住院死亡率。然而，患者血清缺乏对SARS-CoV-2武汉株的中和活性。虽然检测到抗ace2 IgG抗体，但它们的存在与疾病严重程度或炎症反应无关。结论这些结果表明，尽管结合抗体在大流行早期COVID-19患者感染早期普遍存在，但在没有接种疫苗的情况下，血清中和能力仍然较低。抗ace2抗体检测在COVID-19中的临床意义有待进一步研究。

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引用次数: 0

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 患者特征、治疗模式和瑞德西韦在住院的COVID-19合并胰岛素治疗的糖尿病患者中的临床结局：使用日本索赔数据库的大规模数据分析

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus

Pub Date : 2025-05-17 DOI: 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.

目的探讨瑞德西韦（RDV）治疗日本因冠状病毒病-2019 （COVID-19）住院的糖尿病（DM）患者的治疗模式和临床结果。方法：我们使用日本医疗索赔数据库，纳入了年龄≥18岁、接受胰岛素治疗的糖尿病患者、因中重度COVID-19住院且在2021年10月至2022年9月期间接受了≥1剂量RDV治疗的患者的数据。从定义为RDV开始的指标日期起56天内评估全因死亡率、进展到严重COVID-19和出院/康复状况。结果共纳入502例患者。平均（SD）年龄为74.4（12.5）岁。从入院到RDV发生的中位时间（Q1-Q3）为2.0（1.0-3.0）天；中位治疗时间为5.0（3.0-5.0）天。截至指标日，36.85%的患者为中度I型疾病（住院无氧支持），58.96%的患者为中度II型疾病（无创正压通气，低/高流量氧气），4.18%的患者为重度疾病（ICU入院，机械通气或体外膜氧合）。28天和56天全因死亡率分别为11.16% （95% CI, 8.54 ~ 14.24）和13.15%（10.32 ~ 16.42）。28 d时，12.35%（9.60 ~ 15.55）的患者出现疾病进展，68.13%（63.85 ~ 72.19）的患者恢复。结论患者多为老年患者，启动RDV时需吸氧支持。大多数患者在住院3天内接受RDV治疗，28天康复。该研究为在住院环境中接受RDV治疗的日本COVID-19 DM患者的结果提供了见解。

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引用次数: 0

Comprehensive HPV genotyping in Fars, Iran: Molecular epidemiology and implications for prevention 伊朗法尔斯的全面HPV基因分型：分子流行病学和预防意义

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus

Pub Date : 2025-05-16 DOI: 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.

人类乳头瘤病毒（HPV）是最普遍的性传播感染，具有高危基因型，可导致宫颈癌和其他癌症。虽然在伊朗研究了HPV流行病学，但法尔斯省的综合基因型分布数据仍然有限。本研究检查HPV患病率和基因型分布，为区域预防策略提供信息。方法本横断面研究分析了2021年至2024年从临床实验室收集的616份样本。采用巢式PCR检测HPV DNA，并通过反向杂交进行基因分型。统计评估HPV状态、风险分类、性别和样本收集方法之间的关系。结果总体上，56.3%的人HPV检测呈阳性。在56.6%的阳性病例中检测到高危HPV，其中HPV-16（29.6%）和HPV-18（6.8%）是最常见的致癌类型。低危HPV-6（35.0%）和HPV-11（17.1%）也普遍存在。HPV状态与年龄（p = 0.346）、性别（p = 0.998）或样本采集方法（p = 0.998）无显著相关性。结论法尔斯省疫苗覆盖HPV类型的优势强调了扩大筛查和有针对性的预防规划的必要性。虽然人口因素与人乳头瘤病毒状况没有显著相关性，但高风险类型的高负担需要加强区域公共卫生干预。这些发现为加强HPV控制措施和优化疫苗接种政策提供了宝贵的流行病学数据。

{"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}

引用次数: 0

Multicenter performance comparison of the hepatitis C antibody serology assay on the new Atellica integrated chemistry and immunoassay analyzer 新型Atellica综合化学和免疫分析分析仪丙型肝炎抗体血清学检测的多中心性能比较

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus

Pub Date : 2025-05-15 DOI: 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.

背景,为了确保更有效地识别有丙型肝炎病毒（HCV）传播风险的个体，疾病控制中心建议所有成年人都应接受一次性抗HCV血清学检测，这推动了对高性能、自动化HCV血清学检测的需求增加。Atellica CI分析仪是一种新型的独立、高通量集成化学和免疫分析（IM）分析仪。本研究评估了Atellica IM抗hcv抗体（aHCV）测定在美国3个地点的Atellica CI分析仪上的性能。方法对Atellica CI和Atellica IM分析仪进行精度分析、截止偏差分析和定性方法比较研究。使用aHCV阳性个体和HCV暴露风险增加的阴性个体的血清标本（n = 278）以及9个市售HCV血清转化面板进行方法比较。结果在Atellica CI上的重复性和重复性分别为3.0%和6.5%，在各分析仪上对0.80指数及以上样品的重复性和重复性相当。指标值在截止点附近的偏差在分析仪之间估计为- 7%。Atellica CI和Atellica IM分析仪对aHCV样本的阴性和阳性符合率分别为100%和99.23%，对9个HCV血清转化面板的检测符合率为100%。结论本文首次报道了Atellica IM aHCV检测在Atellica CI分析仪上的分析和临床性能。研究结果证明了它在HCV血清学检测中的可靠性，它与Atellica IM分析仪的一致性，并提供了可互换使用这两种分析仪的实际考虑，潜在地支持了中心辐射型实验室环境下的工作流程效率。

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引用次数: 0