ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2021
Evaluation of the clinical and analytical performance of the Seegene allplex™ SARS-CoV-2 variants I assay for the detection of variants of concern (VOC) and variants of interests (VOI).
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 20 citations in OpenAlex.
- Article
- Multiplex RT-qPCR strategy for SARS-CoV-2 variants detection in developing countries without ngs: The Bolivian experience.Epidemiology and infection · 2025Article
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- Multiplexed discrimination of SARS-CoV-2 variants via plasmonic-enhanced fluorescence in a portable and automated device.Nature biomedical engineering · 2023Article
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- Rapid screening of SARS-CoV-2 variants, a key tool for pandemic surveillance.Scientific reports · 2023Article
- Frequency of SARS-CoV-2 variants identified by real-time PCR in the AUNA healthcare network, Peru.Frontiers in public health · 2023Article
- Two-Period Study Results from a Large Italian Hospital Laboratory Attesting SARS-CoV-2 Variant PCR Assay Evolution.Microbiology spectrum · 2022Article
- Sewage surveillance of SARS-CoV-2 at student campus residences in the Western Cape, South Africa.The Science of the total environment · 2022Article
- Clinical Evaluation of Three Commercial RT-PCR Kits for Routine COVID-19 Diagnosis.Pathogens (Basel, Switzerland) · 2022Article
- SARS-CoV-2 RT-PCR to Screen for B.1.617.2 (Delta) Variant of Concern.Diagnostics (Basel, Switzerland) · 2022Article
- Design of SARS-CoV-2 Variant-Specific PCR Assays Considering Regional and Temporal Characteristics.Applied and environmental microbiology · 2022Article
- Comparative Analysis of Five Multiplex RT-PCR Assays in the Screening of SARS-CoV-2 Variants.Microorganisms · 2022Article
- Evaluation of a commercial SARS-CoV-2 multiplex PCR genotyping assay for variant identification in resource-scarce settings.PloS one · 2022Article
- Self-Collected Samples to Detect SARS-CoV-2: Direct Comparison of Saliva, Tongue Swab, Nasal Swab, Chewed Cotton Pads and Gargle Lavage.Journal of clinical medicine · 2021Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHigh-throughput assays for the detection of SARS-CoV-2 variants of concern (VOC) and interest (VOI) are a diagnostic alternative when whole genome sequencing (WGS) is unavailable or limited.
objectiveThis study evaluated the clinical and analytical performance of the Seegene Allplex™ SARS-CoV-2 Variants I assay, which detects the HV69/70 deletion, N501Y and E484K mutations of the S gene.
methodsGenotyping was evaluated on -871 SARS-CoV-2 RNA positive specimens, 408 nasopharyngeal (NP) swabs and 463 saline gargle (SG) specimens, with WGS used as the reference standard. Analytical performance was assessed including stability, reproducibility, limit of detection (LOD), cross-reactivity and interference with various respiratory microorganisms.
resultsThe clinical study revealed sensitivity of 100% (95% CI 99.27%-100%) and specificity of 100% (95% CI 98.99%-100%) for HV69/70 deletion, sensitivity of 100% (95% CI 99.55%-100%) and specificity of 100% (95% CI 93.73% - 100%) for N501Y, and sensitivity of 100% (95% CI 98.94% - 100%) and specificity of 98.10% (95% CI 96.53% - 99.08%) for E484K mutation. The E484Q mutation was detected in 10 specimens of the Kappa variant (B.1.627.1). Analytical performance demonstrated stability and reproducibility over 7 days, and LOD was calculated at 698 cp/mL for NP swab specimens, and 968 cp/mL for SG specimens. No interference or cross-reactivity with other microorganisms was noted.
conclusionThe Allplex™ SARS-CoV-2 Variants I assay is acceptable for clinical use for the detection of variant of concern and variant of interest.
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