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The prognostic potential of fetal platelet count and viral load in prenatal cytomegalovirus infection: A retrospective cohort of 74 cases 胎儿血小板计数和病毒载量在产前巨细胞病毒感染中的预后潜力:74例回顾性队列
IF 3.4 3区 医学 Q2 VIROLOGY Pub Date : 2025-12-17 DOI: 10.1016/j.jcv.2025.105909
Caroline De Coninck , Megane Bellemans , Marie-Luce Delforge , Elena Costa , Catherine Donner

Background

Congenital cytomegalovirus (CMV) infection is the most common congenital infection and a leading cause of childhood deafness and neurological impairment. Prenatal prognosis depends on gestational age at maternal infection, infection type, fetal brain imaging (ultrasound and MRI), and fetal blood markers such as viral load (VL) and platelet (plt) count.

Objectives

We aimed to evaluate the prognostic value of two fetal blood markers — CMV VL and plt count — for fetal, neonatal, and long-term outcomes.

Study design

This retrospective cohort study included 74 cases of cordocentesis performed between 2001 and 2021 at CUB-Hôpital Erasme and CHIREC hospitals in Brussels.

Results

Of the 74 infections, 52 occurred in the first trimester, 20 in the second and 2 in the third. Twenty-one pregnancies were terminated (19 first trimester, 2 s trimester). Severe brain abnormalities on antenatal imaging were significantly associated with being symptomatic at birth (OR 24.5; CI 2.69 – 223.34; p = 0.01) and during follow-up (OR 30.75; CI 4.59 – 205.86; p = 0,00). A fetal platelet count below 100.000/mm³ increased the risk of severe cerebral lesions (OR 2.59; CI 1.09 – 14.28; p = 0.04), but neither VL nor plt count alone correlated significantly with clinical symptoms at birth or later. The positive predictive value for being symptomatic at birth increased from 87.5 % to 100 % when severe imaging abnormalities were combined with VL ≥ 50.000 copies/ml and a plt count < 100.000/mm³ .

Conclusion

In our study, cordocentesis assessing VL and plt count appears to provide limited additional prognostic information beyond severe antenatal brain imaging in fetuses with congenital CMV infection.
先天性巨细胞病毒(CMV)感染是最常见的先天性感染,也是儿童耳聋和神经功能障碍的主要原因。产前预后取决于母体感染时的胎龄、感染类型、胎儿脑成像(超声和MRI)以及胎儿血液标志物,如病毒载量(VL)和血小板(plt)计数。目的:我们旨在评估两种胎儿血液标志物——巨细胞病毒VL和细胞计数——对胎儿、新生儿和长期预后的预后价值。本回顾性队列研究包括2001年至2021年间在布鲁塞尔CUB-Hôpital Erasme和CHIREC医院进行的74例脐带穿刺。结果74例感染中,52例发生在妊娠早期,20例发生在妊娠中期,2例发生在妊娠晚期。终止妊娠21例(早期妊娠19例,晚期妊娠2例)。产前影像学显示的严重脑异常与出生时出现症状显著相关(OR 24.5; CI 2.69 - 223.34; p = 0.01)和随访期间(OR 30.75; CI 4.59 - 205.86; p = 0 000)。胎儿血小板计数低于100.000/mm³ 会增加严重脑病变的风险(OR 2.59; CI 1.09 - 14.28; p = 0.04),但单独的VL和血小板计数与出生时或以后的临床症状均无显著相关性。当严重的影像学异常合并VL≥ 50.000拷贝/ml和plt计数<; 100.000/mm³ 时,出生时有症状的阳性预测值从87.5 %增加到100 %。结论:在我们的研究中,除了对先天性巨细胞病毒感染胎儿进行严重的产前脑成像外,脐带穿刺评估VL和plt计数似乎提供了有限的额外预后信息。
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引用次数: 0
Clinical evaluation of nasal swab specimens in VTM/UTM and RespDirect eSTM using the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay 使用Panther Fusion SARS-CoV-2/流感A/B/RSV试验对VTM/UTM和RespDirect eSTM鼻拭子标本的临床评价
IF 3.4 3区 医学 Q2 VIROLOGY Pub Date : 2025-12-15 DOI: 10.1016/j.jcv.2025.105908
Salika M. Shakir , Robert K. McCall , Rangaraj Selvarangan , Dithi Banerjee , Yitz Goldstein , Christine Lansang , Rachel Bogh , Carmelle V. Remillard , on behalf of the RespDirect Clinical Study Group

Background

Respiratory viral infections by SARS-CoV-2, influenza A and B viruses, and RSV overlap in disease signs and symptomology, but differ in treatment modality. Nasal swab specimens have been shown to be an effective alternative specimen type for SARS-CoV-2 detection.

Objectives

This study evaluated the performance of the Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay in anterior nasal swab specimens (self- or healthcare professional [HCP]-) collected in either viral/universal (VTM/UTM) transport media or the Hologic® RespDirect® collection kit (RespDirect swab in enhanced specimen transport media [eSTM]).

Study design

A multicenter study was conducted from October 2022 to March 2024. A total of 2686 nasal swab specimens collected in VTM/UTM or in eSTM were tested with the investigational assay and comparator molecular assays. Positive and negative agreement were calculated for each viral target.

Results

Overall, the results of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in nasal swab specimens demonstrated high concordance with the nasal swab-based molecular comparator methods with positive and negative percent agreement of 96.6 % and 98.9 % for SARS-CoV-2, 96.1 % and 99.3 % for influenza A virus, 96.0 % and 99.8 % for influenza B virus, and 97.7 % and 99.6 % for RSV, respectively. There were no statistically significant differences between specimens in VTM/UTM and eSTM and between self- or HCP-collected swabs in either transport medium for any of the viral pathogens.

Conclusion

The results of this study indicate that both self- and HCP- collected anterior nasal swabs in VTM or eSTM matrix are suitable options for detecting SARS-CoV-2, influenza A/B, and RSV using the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.
背景SARS-CoV-2、甲型和乙型流感病毒以及RSV引起的呼吸道病毒感染在疾病体征和症状上有重叠,但治疗方式不同。鼻拭子标本已被证明是检测SARS-CoV-2的有效替代标本类型。目的:本研究评估Panther Fusion®SARS-CoV-2/流感A/B/RSV检测在病毒/通用(VTM/UTM)运输介质或Hologic®RespDirect®收集试剂盒(RespDirect拭子在强化标本运输介质[eSTM])中收集的前鼻拭子标本(自我或医疗保健专业人员[HCP]-)中的性能。研究设计一项多中心研究于2022年10月至2024年3月进行。采用研究性分析和比较分子分析对采集于VTM/UTM或eSTM的2686份鼻拭子标本进行检测。计算每个病毒靶点的正一致性和负一致性。结果Panther Fusion鼻拭子标本SARS-CoV-2/流感A/B/RSV检测结果与基于鼻拭子的分子比较方法具有较高的一致性,SARS-CoV-2阳性阳性率为96.6% %,98.9% %;甲型流感病毒阳性率为96.1% %,99.3% %;乙型流感病毒阳性率为96.0% %,99.8% %;RSV阳性阳性率为97.7% %,99.6% %;在VTM/UTM和eSTM标本之间,以及在任何一种运输介质中自行收集或hcp收集的拭子之间,对任何一种病毒病原体没有统计学上的显著差异。结论采用Panther Fusion SARS-CoV-2/流感A/B/RSV检测方法,自体和HCP采集的鼻前拭子在VTM或eSTM基质中均可用于检测SARS-CoV-2、流感A/B/RSV。
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引用次数: 0
Is there a need to repeat single assay reactive HIV screens? A review of practice in two UK sites 是否需要重复单次检测反应性HIV筛查?对英国两个网站实践的回顾。
IF 3.4 3区 医学 Q2 VIROLOGY Pub Date : 2025-12-07 DOI: 10.1016/j.jcv.2025.105906
Callum Goolden , Cheryl Williams , Sabeen Khurshid Zaidi , Joel Paul , Dominic Haigh , Emma Davies , Shazaad Ahmad , Nicholas Machin , Thomas Whitfield

Background

In the United Kingdom, a 3-step algorithm for HIV screening is standard practice. Where there is discordancy between different serological assays, the interpretation of HIV status is challenging and guidance on reporting and follow up is conflicting. Inconclusive HIV results often prompt requests for repeat testing which is known to cause considerable anxiety as well as increased healthcare costs.

Objectives

We aimed to demonstrate the safety and efficacy of reporting single assay reactive HIV screens with a negative serum HIV-1 RNA PCR result as HIV negative, without the requirement for repeat sampling.

Study design

We conducted a retrospective review of local practice across two neighbouring NHS trusts. HIV results were reviewed to determine the proportion of single assay reactivity and to assess if any individuals exhibiting single assay reactivity were found to be HIV-1 positive by PCR, or with interval serological testing.

Results

A total of 1225 (0.26 %) of HIV screening requests exhibited single assay reactivity. None of these were found to be HIV-1 positive by PCR. 356 individuals with single assay reactivity had repeat testing performed, but none were shown to have developed HIV infection.

Conclusions

In our cohort, specimens exhibiting single HIV assay reactivity did not confirm when tested for HIV-1 RNA by PCR, or with interval serological testing of the source individual. This demonstrates the safety and efficacy of a longstanding approach at both NHS trusts.
背景:在英国,HIV筛查的三步算法是标准做法。在不同的血清学检测结果不一致的地方,对艾滋病毒状况的解释是具有挑战性的,报告和随访的指导是相互矛盾的。不确定的艾滋病毒检测结果往往促使人们要求进行重复检测,这众所周知会引起相当大的焦虑,并增加医疗保健费用。目的:我们旨在证明在不需要重复采样的情况下,将血清HIV-1 RNA PCR阴性结果报告为HIV阴性的单试验反应性HIV筛查的安全性和有效性。研究设计:我们对两个相邻的NHS信托机构的当地实践进行了回顾性审查。对HIV检测结果进行审查,以确定单次检测反应性的比例,并评估是否有任何表现出单次检测反应性的个体通过PCR或间隔血清学检测被发现为HIV-1阳性。结果:共有1225例(0.26 %)HIV筛查请求呈现单法反应性。这些人都没有通过PCR发现HIV-1阳性。356例具有单分析反应性的个体进行了重复检测,但没有显示出发生HIV感染。结论:在我们的队列中,当用PCR检测HIV-1 RNA或对源个体进行间歇血清学检测时,显示单一HIV检测反应性的标本未得到证实。这证明了NHS信托长期方法的安全性和有效性。
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引用次数: 0
The diagnostic complexities of human herpesvirus 6 (HHV-6) infections 人类疱疹病毒6 (HHV-6)感染的诊断复杂性。
IF 3.4 3区 医学 Q2 VIROLOGY Pub Date : 2025-12-04 DOI: 10.1016/j.jcv.2025.105905
Katelyn L. Gough , Taylah K. Anderson , David M. Whiley , Emma L. Sweeney
Human herpesvirus 6 (HHV-6) is a common virus which is typically acquired early in childhood, and like other herpesviruses, can induce lifelong latency. While healthy individuals are not at risk of disease, immunosuppressed individuals such as those receiving hematopoetic stem cell transplantation are at substantial risk of morbidity and non-relapse mortality. Swift diagnosis and treatment remain crucial for the timely management of infections and reduce the severity of complications. A range of diagnostic approaches to detect HHV-6 have been established, the most common of which include PCR and serology; however, substantial challenges remain. Namely, existing diagnostic techniques struggle to differentiate between active HHV-6 infection, latency and chromosomal integration of HHV-6, which occurs in around 1 % of the population. Here, we discuss the established and emerging diagnostic tools for HHV-6, their strengths and limitations, and considerations for future diagnosis of this challenging viral pathogen.
人类疱疹病毒6 (HHV-6)是一种常见的病毒,通常在儿童早期获得,像其他疱疹病毒一样,可以诱发终身潜伏。虽然健康个体没有患病风险,但免疫抑制个体(如接受造血干细胞移植的个体)有很大的发病率和非复发性死亡率风险。迅速诊断和治疗对于及时控制感染和减少并发症的严重程度仍然至关重要。已经建立了一系列检测HHV-6的诊断方法,其中最常见的包括聚合酶链反应和血清学;然而,重大挑战依然存在。也就是说,现有的诊断技术很难区分活跃的HHV-6感染、潜伏的HHV-6和染色体整合的HHV-6,这发生在大约1 %的人群中。在这里,我们讨论了现有的和新兴的HHV-6诊断工具,它们的优势和局限性,以及对这种具有挑战性的病毒性病原体的未来诊断的考虑。
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引用次数: 0
Optimized respiratory virus influenza A whole genome sequencing strategies for improving even read coverage of segments 优化呼吸道病毒甲型流感全基因组测序策略,提高片段的均匀阅读覆盖率
IF 3.4 3区 医学 Q2 VIROLOGY Pub Date : 2025-12-03 DOI: 10.1016/j.jcv.2025.105904
Ruimin Gao, Kennedy Irvine, Cody Buchanan, Cole Slater, Nikki PL Toledo, Jianjun Jia, Ameet Bharaj, Brittany Lagasse, April Powell, Nathalie Bastien
Whole genome sequencing is increasingly being deployed to support respiratory virus influenza clinical studies and surveillance. However, PCR amplification inefficiency results in an imbalanced distribution among the eight segments, which makes it challenging to obtain complete genomes. The difficulties of amplifying the longer polymerase genes, particularly when the cycle threshold (Ct) of a specimen is greater than 25, were highlighted by the whole genome sequencing (WGS) data of 109 influenza A virus (IAV) specimens. We addressed the low genome coverage of the PB1 segment by incorporating additional singleplex PB1 primers into the WGS PCR assay, as well as balancing the ratio of forward primer variants targeting a single nucleotide polymorphism – either uracil (U) or cytosine (C) – located at the 4th position of the promoter region at the 3’ terminus. Furthermore, we have verified the improved performance of the Invitrogen™ UniPrime™ enzyme when compared to its predecessor, SuperScript IV™, and developed a more efficient thermal cycling condition (“C”) to generate eight complete IAV segments. Lastly, we determined that the optimal amplicon-to-bead volume ratio for removal of shorter, unwanted DNA fragments during PCR amplicon purification is 1:0.5. In summary, these optimizations improve the recovery of lower coverage segments and provide strategies aimed at obtaining high quality IAV genomes by means of Oxford Nanopore Technologies-based sequencing, ultimately providing valuable insights for better serving influenza clinical research and surveillance.
全基因组测序越来越多地被用于支持呼吸道病毒流感临床研究和监测。然而,由于PCR扩增效率低,导致8个片段之间分布不平衡,这给获得完整基因组带来了挑战。109个甲型流感病毒(IAV)标本的全基因组测序(WGS)数据强调了扩增较长聚合酶基因的困难,特别是当标本的周期阈值(Ct)大于25时。为了解决PB1片段基因组覆盖率低的问题,我们在WGS PCR实验中加入了额外的单双链PB1引物,并平衡了位于3 '端启动子区域第4位的单核苷酸多态性(尿嘧啶(U)或胞嘧啶(C))的前引物变体的比例。此外,我们已经验证了与上一代SuperScript IV™相比,Invitrogen™UniPrime™酶的性能有所改善,并开发了更有效的热循环条件(“C”)来生成8个完整的IAV片段。最后,我们确定扩增子纯化过程中去除较短、不需要的DNA片段的最佳扩增子与头的体积比为1:0.5。总之,这些优化提高了低覆盖段的恢复,并提供了旨在通过基于牛津纳米孔技术的测序获得高质量IAV基因组的策略,最终为更好地服务于流感临床研究和监测提供了有价值的见解。
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引用次数: 0
In Memoriam 为纪念
IF 3.4 3区 医学 Q2 VIROLOGY Pub Date : 2025-12-01 DOI: 10.1016/j.jcv.2025.105878
Richard L. Hodinka
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引用次数: 0
Fourth generation HIV rapid diagnostic test: Adequate sensitivity in HIV primary infection settings? 第四代HIV快速诊断测试:在HIV原发感染环境中是否足够敏感?
IF 3.4 3区 医学 Q2 VIROLOGY Pub Date : 2025-11-30 DOI: 10.1016/j.jcv.2025.105903
Vincent Guiraud , Sofia Ben Attia , Nathalie Hamm , Luigi Piccin , Ay Ling Leng , Agnès Gautheret-Dejean

Background

HIV rapid diagnostic tests (RDT) enable easy point-of-care screenings but traditionally lack the HIV-1 p24-antigen detection, resulting in poor diagnostic window, up to three months after exposure. Fourth-generation HIV RDTs aimed to address this issue, through independent detection of p24-antigen and HIV-antibodies, but their performances in primary infection settings remains understudied.

Objective

To compare the sensitivity of two fourth-generation HIV RDTs, Determine™ Early Detect (Determine) and AQ+ HIV Ag/Ab Combo (AQ+), in primary HIV-1 infection samples.

Methods

Sensitivity of Determine and AQ+ was assessed using 162 primary infection samples. Primary infection was determined using the New Lav blot I (Bio-Rad) Western blot, with pre-seroconversion defined by a p24-positivity with the absence of HIV-1 antibodies on the 4th generation enzyme immunoassay Liaison XL. HIV-1 infection dates were retrieved from medical records.

Results

Overall sensitivity [95 % CI] was at 94.4 % [89.8–97.1 %] and 96.9 % [93.0–98.7 %] for Determine and AQ+ , respectively (p = 0.22). Pre-seroconversion sensitivity was at 66.7 % [47.8–81.3 %] and 81.5 % [63.3–91.8 %] for Determine and AQ+ , respectively (p = 0.22). All seroconversion samples were reactive on both assays. Regarding window periods, no assay was reactive the two first weeks after infection (n = 2), Between two and three weeks after infection (n = 11), sensitivity was at 73 % [43–90 %] and 91 % [62–98 %] for Determine and AQ+ , respectively. After three weeks (n = 26), all samples were reactive on both assays, with a 100 % [87–100 %] sensitivity.

Conclusion

Fourth-generation HIV RDT can be useful for a suspected primary HIV-1 infection, but should be used with caution the first three weeks post-infection.
背景:艾滋病毒快速诊断测试(RDT)可以方便地在护理点进行筛查,但传统上缺乏艾滋病毒-1 p24抗原检测,导致暴露后长达三个月的诊断窗口期很差。第四代HIV rdt旨在通过独立检测p24抗原和HIV抗体来解决这一问题,但它们在原发性感染环境中的表现仍有待研究。目的:比较两种第四代HIV RDTs (decide™Early Detect (decide))和AQ+ HIV Ag/Ab Combo (AQ+)在原发HIV-1感染样本中的敏感性。方法:对162例原发感染标本进行测定和AQ+ 的敏感性评价。使用New Lav blot I (Bio-Rad) Western blot检测原发感染,血清前转化为p24阳性,第四代酶免疫分析法Liaison XL中没有HIV-1抗体。从医疗记录中检索HIV-1感染日期。结果:测定法和AQ+ 的总灵敏度[95 % CI]分别为94.4 %[89.8 ~ 97.1 %]和96.9 %[93.0 ~ 98.7 %](p = 0.22)。测定和AQ+ 血清前转化敏感性分别为66.7 %[47.8 ~ 81.3 %]和81.5 %[63.3 ~ 91.8 %](p = 0.22)。所有血清转化样本在两项检测中均有反应。关于窗口期,没有活性测定一分之二周后感染(n = 2),两到三周后感染(n = 11),灵敏度为73 %(43 - 90 %)和91年 %(62 - 98年 %)为确定和AQ + ,分别。三周后(n = 26),所有样品对两种检测都有反应,灵敏度为100% %[87-100 %]。结论:第四代HIV RDT可用于疑似原发性HIV-1感染,但在感染后的前三周应谨慎使用。
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引用次数: 0
Peptide-assisted direct detection of HPV nucleic acids from liquid-based cytology samples without extraction 多肽辅助直接检测HPV核酸液基细胞学样品,无需提取。
IF 3.4 3区 医学 Q2 VIROLOGY Pub Date : 2025-11-29 DOI: 10.1016/j.jcv.2025.105901
Sadia Almas , Salima Karki , Rob E. Carpenter , Vaibhav K. Tamrakar , Aditya Sharma , Kamalpreet Suri , Rahul Sharma
High-risk human papillomavirus remains the causal agent of nearly all cervical cancers. And we need tools for rapid detection that work in routinely taken samples (e.g., PreservCyt®) that can speed up, facilitate or simplify the extraction process. Conventional workflows rely on nucleic-acid extraction, a cost- and labor-intensive step that restricts scalability in both high-throughput and resource-limited settings. Here, we introduce MDP-1, a rationally designed peptide that represents the prototype of a new class of capsid-targeted diagnostic enhancers. Unlike antimicrobial peptides historically developed for therapeutic membrane lysis, MDP-1 was engineered to bind the HPV L1 major capsid protein, interfere with L1–L1 interactions, and promote partial capsid destabilization to enhance genome accessibility. In silico docking demonstrated favorable binding (HADDOCK score –173.4 ± 6.2; BSA 1958 ± 83.9 Ų; RMSD 1.8 ± 0.1 Å) with extensive electrostatic and hydrophobic complementarity. When integrated into a direct-to-PCR workflow, MDP-1 enabled robust amplification from unextracted PreservCyt® specimens, maintaining efficiencies within 90–110 % and achieving a limit of detection of 1.25 copies/µL. Analytical specificity testing confirmed no cross-reactivity, while interference studies showed tolerance to common clinical inhibitors. In a feasibility cohort (n = 53), the MDP-1 workflow achieved 93.5 % sensitivity (95 % CI: 78.6–99.2) and 99.3 % specificity (95 % CI: 85.4–99.9) for the detection of high-risk HPV DNA, with an overall accuracy of 98.5 % compared to extraction-based qPCR and strongly correlated Ct values (R² = 0.772). This proof-of-concept positions MDP-1 as a first-in-class tool that recasts HPV diagnostics by leveraging peptide–virion interactions to bypass inhibitors and eliminate timely and costly extraction workflows.
高危人乳头瘤病毒仍然是几乎所有宫颈癌的致病因子。我们还需要能够在常规样品中快速检测的工具(例如,PreservCyt®),这些工具可以加速、促进或简化提取过程。传统的工作流程依赖于核酸提取,这是一个成本和劳动密集型的步骤,在高通量和资源有限的环境下限制了可扩展性。在这里,我们介绍了MDP-1,这是一种合理设计的肽,代表了一类新的衣壳靶向诊断增强子的原型。与历史上用于治疗性膜裂解的抗菌肽不同,MDP-1被设计成结合HPV L1主要衣壳蛋白,干扰L1-L1相互作用,促进部分衣壳不稳定,以增强基因组的可及性。在硅对接中表现出良好的结合(HADDOCK得分-173.4 ± 6.2;BSA得分1958 ± 83.9 Ų;RMSD得分1.8 ± 0.1 Å),具有广泛的静电和疏水互补。当集成到直接到pcr工作流程时,MDP-1能够从未提取的PreservCyt®标本中进行稳健扩增,将效率保持在90-110 %,并实现1.25拷贝/µL的检测限。分析特异性测试证实无交叉反应性,而干扰研究显示对常见临床抑制剂耐受。在可行性队列(n = 53)中,与基于提取的qPCR和强相关的Ct值(R²= 0.772)相比,MDP-1工作流程检测高危HPV DNA的灵敏度为93.5% %(95 % CI: 78.6-99.2)和特异性为99.3% %(95 % CI: 85.4-99.9),总体准确性为98.5% %。这一概念验证将MDP-1定位为一流的工具,通过利用肽-病毒粒子相互作用来绕过抑制剂,消除及时和昂贵的提取工作流程,从而重塑HPV诊断。
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引用次数: 0
Head-to-head comparison of the performance of BIOFIRE® SPOTFIRE® Respiratory/Sore Throat Panel, Cepheid Xpert® Xpress SARS-CoV-2/Flu/RSV and Cobas® SARS-CoV-2 & Influenza A/B assay for detection of respiratory viruses BIOFIRE®SPOTFIRE®呼吸/喉咙痛检测试剂盒、Cepheid Xpert®Xpress SARS-CoV-2/Flu/RSV和Cobas®SARS-CoV-2 &流感A/B检测试剂盒检测呼吸道病毒的性能进行正面比较
IF 3.4 3区 医学 Q2 VIROLOGY Pub Date : 2025-11-27 DOI: 10.1016/j.jcv.2025.105902
Dithi Banerjee, Anjana Sasidharan, Stephanie Gummersheimer, Sydnie Petty, Amanda O’Connor, Minati Dhar, Rangaraj Selvarangan

Background

We compared the performance of 3 multiplex respiratory platforms - BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel (BioMérieux), Xpert® Xpress SARS-CoV-2/Flu/RSV assay (Cepheid) and Cobas® SARS-CoV-2 & Influenza A/B assay (Roche) to detect Flu A/ B, SARS CoV-2 and RSV from nasopharyngeal swabs (NPS).

Method

A total of 250 leftover pediatric NPS from routine clinical testing (50 positives for each target and 50 negatives) were tested on all 3 platforms. Results were compared to a composite reference standard to calculate positive percent agreement (PPA) and negative percent agreement (NPA). For RSV, PPA and NPA were calculated by comparing Xpress and SPOTFIRE assays only. Discrepant samples were tested by single-plex PCRs for each viral target.

Results

PPA ranged between 97 % and 100 % for all targets except SARS-CoV-2 (86–97 %); NPA was > 95 % by all assays. SPOTFIRE reported 35 (14 %) discrepant samples, Xpress and Liat reported 31 (12.4 %) and 14 (5.6 %) samples respectively. SPOTFIRE was positive for an additional respiratory virus (excluding Flu A/B, SARS-CoV-2 and RSV) in 110/250 (44 %) samples. All samples with initial invalid results on Xpress (5, 2 %), SPOTFIRE (3, 1.2 %) and Liat (2, 0.8 %) were valid on re-testing. Total hands-on time (specimen processing and loading, retrieving results) was less than 5 min for all assays.

Conclusion

All 3 assays showed 95 % agreement for Flu A and B detection; performance for SARS-CoV-2 detection varied. SPOTFIRE provides an advantage of detecting additional respiratory pathogens. Overall, the assays were easy to perform with minimum technical skill.
我们比较了BIOFIRE®SPOTFIRE®呼吸/咽喉痛(R/ST) Panel (biomacrieux)、Xpert®Xpress SARS-CoV-2/Flu/RSV assay (Cepheid)和Cobas®SARS-CoV-2 & Influenza A/B assay (Roche)这3种多重呼吸平台检测鼻咽拭子(NPS)流感A/B、SARS-CoV-2和RSV的性能。方法在所有3个平台上对常规临床检测剩余的250例小儿NPS进行检测(每个目标50例阳性,50例阴性)。将结果与综合参考标准进行比较,计算阳性同意率(PPA)和阴性同意率(NPA)。RSV的PPA和NPA仅通过比较Xpress和SPOTFIRE测定法计算。每个病毒靶点的不同样本用单plex pcr检测。结果除SARS-CoV-2(86 ~ 97 %)外,其他靶点的sppa均在97 % ~ 100 %之间;所有检测NPA为>; 95 %。SPOTFIRE报告了35个(14 %)差异样本,Xpress和Liat分别报告了31个(12.4 %)和14个(5.6 %)样本。SPOTFIRE在110/250(44% %)样本中对另一种呼吸道病毒(不包括流感A/B、SARS-CoV-2和RSV)呈阳性。所有在Xpress(5,2 %)、SPOTFIRE(3,1.2 %)和Liat(2,0.8 %)上初始无效的样品在重新检测时均有效。所有检测的总动手时间(标本处理和装载,检索结果)均小于5 min。结论3种方法检测甲型流感和乙型流感的符合率为95% %;对SARS-CoV-2的检测效果不同。SPOTFIRE提供了检测额外呼吸道病原体的优势。总的来说,用最少的技术技能就可以很容易地进行测定。
{"title":"Head-to-head comparison of the performance of BIOFIRE® SPOTFIRE® Respiratory/Sore Throat Panel, Cepheid Xpert® Xpress SARS-CoV-2/Flu/RSV and Cobas® SARS-CoV-2 & Influenza A/B assay for detection of respiratory viruses","authors":"Dithi Banerjee,&nbsp;Anjana Sasidharan,&nbsp;Stephanie Gummersheimer,&nbsp;Sydnie Petty,&nbsp;Amanda O’Connor,&nbsp;Minati Dhar,&nbsp;Rangaraj Selvarangan","doi":"10.1016/j.jcv.2025.105902","DOIUrl":"10.1016/j.jcv.2025.105902","url":null,"abstract":"<div><h3>Background</h3><div>We compared the performance of 3 multiplex respiratory platforms - BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel (BioMérieux), Xpert® Xpress SARS-CoV-2/Flu/RSV assay (Cepheid) and Cobas® SARS-CoV-2 &amp; Influenza A/B assay (Roche) to detect Flu A/ B, SARS CoV-2 and RSV from nasopharyngeal swabs (NPS).</div></div><div><h3>Method</h3><div>A total of 250 leftover pediatric NPS from routine clinical testing (50 positives for each target and 50 negatives) were tested on all 3 platforms. Results were compared to a composite reference standard to calculate positive percent agreement (PPA) and negative percent agreement (NPA). For RSV, PPA and NPA were calculated by comparing Xpress and SPOTFIRE assays only. Discrepant samples were tested by single-plex PCRs for each viral target.</div></div><div><h3>Results</h3><div>PPA ranged between 97 % and 100 % for all targets except SARS-CoV-2 (86–97 %); NPA was &gt; 95 % by all assays. SPOTFIRE reported 35 (14 %) discrepant samples, Xpress and Liat reported 31 (12.4 %) and 14 (5.6 %) samples respectively. SPOTFIRE was positive for an additional respiratory virus (excluding Flu A/B, SARS-CoV-2 and RSV) in 110/250 (44 %) samples. All samples with initial invalid results on Xpress (5, 2 %), SPOTFIRE (3, 1.2 %) and Liat (2, 0.8 %) were valid on re-testing. Total hands-on time (specimen processing and loading, retrieving results) was less than 5 min for all assays.</div></div><div><h3>Conclusion</h3><div>All 3 assays showed 95 % agreement for Flu A and B detection; performance for SARS-CoV-2 detection varied. SPOTFIRE provides an advantage of detecting additional respiratory pathogens. Overall, the assays were easy to perform with minimum technical skill.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105902"},"PeriodicalIF":3.4,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623054","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}
引用次数: 0
Bacterial colonization and life-threatening respiratory syncytial virus infection in children 儿童细菌定植和危及生命的呼吸道合胞病毒感染
IF 3.4 3区 医学 Q2 VIROLOGY Pub Date : 2025-11-25 DOI: 10.1016/j.jcv.2025.105891
Eduardo L. López , Fausto Martín Ferolla , Agustina F. Denardi , Noelia Iraizos , Ana Fernández , María M. Contrini , Patricio L. Acosta

Background

Respiratory syncytial virus is a major cause of acute respiratory infection in children. While most cases are mild, some progress to life-threatening disease. The role of bacterial colonization in shaping respiratory syncytial virus outcomes remains incompletely understood.

Objective

To evaluate the association between respiratory tract bacterial colonization and respiratory syncytial virus disease severity in children.

Study design

Prospective cohort study conducted during 2019 and 2023. Children ≤ 24 months hospitalized with confirmed positive respiratory syncytial virus infection were enrolled. Clinical and epidemiological data were collected. respiratory syncytial virus subtypes, viral load, and detection of Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis were determined by qPCR.

Results

401 patients were hospitalized with acute respiratory infection, of which 172 (42.9 %) had confirmed respiratory syncytial virus infection. Among them, 15 (8.7 %) developed life-threatening disease. Bacterial colonization was highly prevalent (92.4 %): H. influenzae (68 %), S. pneumoniae (64.5 %), and M. catarrhalis (52.9 %). M. catarrhalis colonization was associated with mild disease (p = 0.003), while H. influenzae showed a trend toward increased severity (p = 0.054). Viral subtype and viral load were not linked to severity. Household crowding was independently associated with more severe disease (p = 0.031).

Conclusions

Our results support the growing evidence that airway microbiota modulates respiratory syncytial virus outcomes and highlights M. catarrhalis as potential microbial determinant of disease progression.
呼吸道合胞病毒是儿童急性呼吸道感染的主要原因。虽然大多数病例病情轻微,但有些会发展为危及生命的疾病。细菌定植在形成呼吸道合胞病毒结果中的作用仍然不完全清楚。目的探讨儿童呼吸道细菌定植与呼吸道合胞病毒疾病严重程度的关系。研究设计2019年至2023年进行的前瞻性队列研究。纳入≤ 确诊呼吸道合胞病毒阳性感染住院24个月的儿童。收集临床和流行病学资料。采用qPCR检测呼吸道合胞病毒亚型、病毒载量以及流感嗜血杆菌、肺炎链球菌和卡他莫拉菌的检测。结果401例急性呼吸道感染住院,其中确诊呼吸道合胞病毒感染172例(42.9% %)。其中15例(8.7% %)发展为危及生命的疾病。细菌定植非常普遍(92.4 %):流感嗜血杆菌(68 %)、肺炎链球菌(64.5 %)和卡塔林支原体(52.9% %)。卡塔林分枝杆菌的定植与轻度疾病相关(p = 0.003),而流感嗜血杆菌的定植呈加重趋势(p = 0.054)。病毒亚型和病毒载量与严重程度无关。家庭拥挤与更严重的疾病独立相关(p = 0.031)。结论我们的研究结果支持气道微生物群调节呼吸道合胞病毒结局的证据,并强调卡他分枝杆菌是疾病进展的潜在微生物决定因素。
{"title":"Bacterial colonization and life-threatening respiratory syncytial virus infection in children","authors":"Eduardo L. López ,&nbsp;Fausto Martín Ferolla ,&nbsp;Agustina F. Denardi ,&nbsp;Noelia Iraizos ,&nbsp;Ana Fernández ,&nbsp;María M. Contrini ,&nbsp;Patricio L. Acosta","doi":"10.1016/j.jcv.2025.105891","DOIUrl":"10.1016/j.jcv.2025.105891","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory syncytial virus is a major cause of acute respiratory infection in children. While most cases are mild, some progress to life-threatening disease. The role of bacterial colonization in shaping respiratory syncytial virus outcomes remains incompletely understood.</div></div><div><h3>Objective</h3><div>To evaluate the association between respiratory tract bacterial colonization and respiratory syncytial virus disease severity in children.</div></div><div><h3>Study design</h3><div>Prospective cohort study conducted during 2019 and 2023. Children ≤ 24 months hospitalized with confirmed positive respiratory syncytial virus infection were enrolled. Clinical and epidemiological data were collected. respiratory syncytial virus subtypes, viral load, and detection of <em>Haemophilus influenzae</em>, <em>Streptococcus pneumoniae</em>, and <em>Moraxella catarrhalis</em> were determined by qPCR.</div></div><div><h3>Results</h3><div>401 patients were hospitalized with acute respiratory infection, of which 172 (42.9 %) had confirmed respiratory syncytial virus infection. Among them, 15 (8.7 %) developed life-threatening disease. Bacterial colonization was highly prevalent (92.4 %): <em>H. influenzae</em> (68 %), <em>S. pneumoniae</em> (64.5 %), and <em>M. catarrhalis</em> (52.9 %). <em>M. catarrhalis</em> colonization was associated with mild disease (p = 0.003), while <em>H. influenzae</em> showed a trend toward increased severity (p = 0.054). Viral subtype and viral load were not linked to severity. Household crowding was independently associated with more severe disease (p = 0.031).</div></div><div><h3>Conclusions</h3><div>Our results support the growing evidence that airway microbiota modulates respiratory syncytial virus outcomes and highlights <em>M. catarrhalis</em> as potential microbial determinant of disease progression.</div></div>","PeriodicalId":15517,"journal":{"name":"Journal of Clinical Virology","volume":"182 ","pages":"Article 105891"},"PeriodicalIF":3.4,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623055","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}
引用次数: 0
期刊
Journal of Clinical Virology
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