ArticleCurrent microbiology2026
Development and Validation of a Streamlined Multiplex RT-PCR Assay for Accurate SARS-CoV-2 Detection in Diverse Healthcare Environments.
Article in Current microbiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
7 authors.
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Abstract
The global spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), has triggered an extraordinary global disturbance. According toWHO epidemiological reports (June 2025) indicate the COVID-19 pandemic has resulted in approximately 778 million confirmed infections and 7 million attributable fatalities globally. The swift mutation of SARS-CoV-2 and the arrival of multiple variants highlight the critical need for rapid, accurate diagnostic assays to monitor and mitigate public health risks. This study presents the development and validation of a multiplex reverse transcription-PCR (RT-PCR) assay designed for sensitive and specific SARS-CoV-2 detection. The assay simultaneously targets two highly conserved viral genes (ORF1ab and N) along with human RNase P as an internal control. Comprehensive analytical validation using plasmid standards (1.5–150,000 copies/µL) confirmed a limit of detection (LOD) of 1.5 copies/µL, high amplification efficiency (97.7–102.2%), and excellent reproducibility (coefficient of variation < 5%). Clinical evaluation with 193 patient samples (N = 193:102 positive, 91 negative) demonstrated 100% concordance with commercial assays (diagnostic sensitivity/specificity: 100%), with results achievable in < 90 min. This rigorously validated, platform-independent assay provides a cost-effective and efficient diagnostic option, meeting WHO target product profile requirements and is suitable for use in both high-throughput and resource-limited laboratory settings.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.