Journal of Virological Methods

Influenza A, Influenza B, SARS-CoV-2, Respiratory Syncytial Virus and other respiratory pathogens are an ongoing public health concern. The ability to rapidly identify these viruses early in infection is essential for effective treatment and outbreak control. The AMDI Fast PCR Mini Respiratory Panel (MRP) incorporates sample preparation and real-time RT-PCR for detection of Flu A, Flu B, SARS-CoV-2 and RSV from anterior nasal swab (ANS) specimens in less than 10 minutes at the point of care. We ...

BackgroundErythrocyte indices are essential for the diagnosis and monitoring of hematologic diseases, but their determination depends on automated hematology analyzers, which limits access in regions with limited laboratory infrastructure. Although artificial intelligence approaches have been proposed for hematologic analysis, they usually rely on slide scanners or digitization systems. To date, no validated approaches have been identified in the literature that estimate these indices directly f...

BackgroundThere is a need for synthetic peptide-based serologic assays that exploit avidity to replace whole antigens while enabling low-cost diagnostics in resource-limited settings. ObjectiveTo evaluate the diagnostic accuracy of a polymeric peptide-based ELISA leveraging avidity to enhance signal. MethodA 15-member SARS-CoV-2 peptide library corresponding to multiple epitope clusters and proteins was screened by indirect ELISA using pooled sera from RT-PCR-confirmed COVID-19 patients to ide...

BackgroundAccurate and consistent laboratory measurements are essential for reliable diagnosis and clinical decision making. However, variability among automated analyzers can compromise diagnostic reliability and in population studies, instrument-specific differences in estimates hinder meaningful cross-study comparisons. ObjectiveTo evaluate inter-platform variability and interchangeability of laboratory parameters relevant to disease diagnosis across Beckman, Siemens and Roche automated anal...

Point-of-care (POC) blood testing enables rapid, decentralized diagnostics with transformative promise, yet its innovation landscape remains poorly mapped. To this end, we focused on features that we believe are key to make progress in areas of precision healthcare and predictive medicine, such as longitudinal data collection and data analytics integration. While no review can be complete, this work attempts to address this gap by analyzing 86 POC blood testing devices worldwide and proposing a ...

We evaluated the BOSCH Vivalytic MPXV assay using serial dilutions of monkeypox virus clade Ib, a new offshoot of clade I identified in 2023. The assay detected viral DNA down to [~]100 copies/mL demonstrating comparable analytical sensitivity to our in-house reference PCR and to other commercial platform-based mpox molecular assays.

Over-the-counter (OTC) lateral flow tests for respiratory viruses have newly emerged since the beginning of the coronavirus disease 2019 (COVID-19) pandemic and are increasingly available to consumers. While all marketed tests have met standards for Emergency Use Authorization (EUA), De Novo classification or 510(k) clearance, limited data are available to inform consumers of their relative performance. We performed a head-to-head benchtop analytical assessment of OTC tests available for purchas...

Microbial keratitis is a sight-threatening corneal infection with varying etiological agents, primarily bacteria and fungi. Assessing and contrasting the virulence factors of microorganisms isolated from a non-contact lens-associated keratitis (NCLAK) and contact lens-associated keratitis (CLAK) is the goal of the current investigation. Samples were collected from over 60 patients and analysed using standard microbiological techniques, including culture, Gram staining, KOH mount, biochemical tes...

Emerging infectious diseases often circulate undetected until they cause clinical illness, creating serious risks for public health and biosecurity. The U.S. blood supply, with millions of routinely collected and quality-controlled donations, offers an untapped national resource for proactive pathogen surveillance. We propose integrating metagenomic sequencing (MGS) into existing blood and plasma collection workflows to detect novel or unexpected viruses in deidentified residual samples. This ap...

BackgroundSevere Fever with Thrombocytopenia Syndrome (SFTS) is an acute infectious disease with high mortality. This study aimed to develop a quantitative scoring system for grading SFTS severity using dynamic clinical data. MethodsA retrospective study included 547 confirmed SFTS patients from two hospitals. Clinical data were collected over a 14-day course (divided into four phases). Patients were grouped into survivors (n=451) and non-survivors (n=96). Statistical analyses, including Kaplan...

Ziehl-Neelsen (ZN) smear microscopy remains central to tuberculosis (TB) diagnosis and treatment monitoring, yet its sensitivity is limited by incomplete recovery of Mycobacterium tuberculosis during pre-analytical processing. This study evaluated whether modifying centrifugation force and duration improves bacillary recovery and ZN smear performance. Laboratory experiments were conducted using M. tuberculosis H37Rv and pulmonary TB sputum samples. Following NALC-NaOH decontamination, samples we...

Herpes simplex virus (HSV) is an endemic pathogen, infecting most adults world-wide. HSV infection can cause a wide spectrum of disease outcomes, ranging from asymptomatic infection or mild lesions to rare cases of infectious keratitis, encephalitis, and death. HSV genome sequences have been shown to differ between individual patients, as well as within individuals. To date, the vast majority of publicly available HSV genomic data has come from Europe and North America. Our current understanding...

Inter-alpha Inhibitor Proteins (IAIP) are serine protease inhibitors and a reliable inflammatory biomarker. We have demonstrated that IAIP levels decrease during sepsis in humans and animal models. Currently, enzyme-linked immunosorbent assay (ELISA) is the standard procedure to measure IAIP levels. We developed a lateral flow immunoassay (LFIA) that allows rapid, point of care detection. We compared IAIP levels in infants with sepsis and/or necrotizing enterocolitis (NEC) by ELISA and LFIA in a...

BackgroundTransfusion-transmitted malaria remains a concern in non-endemic regions due to asymptomatic parasitemia in donors with prior residence in or travel to malaria-endemic areas. Nucleic acid testing (NAT)-based screening has been proposed to mitigate this risk, and supplemental assays are needed to confirm reactive donations. We developed a pan-Plasmodium reverse transcription quantitative PCR (RT-qPCR) assay with species identification capability as a supplemental tool for malaria donor ...

BackgroundAccurate and comparable human papillomavirus (HPV) testing is essential for HPV vaccine research, HPV surveillance, and cervical cancer screening. In 2008, the WHO HPV Laboratory Network initiated global HPV proficiency testing traceable to International Standards (IS), which has been issued regularly since. Here, we summarize recent results and trends over time. MethodsThe HPV genotyping panel, used since 2008, consists of 43 blinded samples, including HPV 6, HPV 11, all oncogenic an...

Carbapenem-resistant (CR) bacteria have emerged and been spreading beyond healthcare-associated facilities into the environment. It is recognized that toilet bowl water in patient rooms of healthcare-associated facilities can be one of internal reservoirs of CR bacteria. In accordance with this idea, toilet bowl water samples were collected from patient rooms in a tertiary healthcare-associated facility in North Macedonia, and meropenem (MEM)-resistant bacterial isolates were obtained from the t...

The rapid diagnosis of Campylobacter infections is important for the management of infectious gastroenteritis. Although stool culture is considered the gold standard, its sensitivity is limited and it requires prolonged incubation times. We performed a prospective multicenter study at nine healthcare facilities in Japan to evaluate a Campylobacter rapid antigen test using stool specimens between March 2024 and August 2025. Patients with suspected infectious gastroenteritis were consecutively enr...

BackgroundsFollowing an increase in mpox clade Ib cases in several African countries, the World Health Organization recognized mpox as a public health emergency of international concern, highlighting the need for reliable and accessible diagnostic tools. As several mpox clades are co-circulating in endemic countries, the analytical sensitivity of diagnostic assays should be evaluated for all of them in a comparative manner. MethodsThis study evaluated the analytical sensitivity of three rapid t...

ObjectiveIn vitro cytokine release assays are essential tools in immunological research, yet their reliability can be influenced by various pre-analytical factors. This study was initiated to investigate the potential impact of lithium heparin whole blood collection tubes from different manufacturers on assay performance. The objective of this work is to urge the scientific community to consider whole blood collection tubes as a significant and often underestimated source of variability in cell-...

Since 2014, Cubas National Tuberculosis Control and Elimination Program (PNCET, acronym in Spanish) has been using the Xpert(R) MTB/RIF technique (Cepheid, Sunnyvale, CA, USA) for rapid molecular diagnosis of tuberculosis (TB). Due to financial limitations and difficult access to kits and cartridges (both of which are of U.S. origin), this test is only intended for prioritized vulnerable groups. Thus, only one third of the cases reported annually are diagnosed by rapid tests, as an initial techn...