EURM-014k: A New Certified Reference Material for SARS-CoV-2 Detection
Thomas Linsinger
Scientific Official at European Commission, JRC ,Directorate F - Health, Consumers and Reference Materials
The Joint Research Centre (JRC) is pleased to announce the release of EURM-014k, a certified reference material (CRM) for the detection of SARS-CoV-2 by reverse transcription (digital) polymerase chain reaction (RT-PCR). This CRM is designed to support the accurate quantification of both existing and emerging SARS-CoV-2 variants.
The COVID-19 pandemic has highlighted the need for accurate and reliable diagnostic tools to detect SARS-CoV-2. The current methods for detecting SARS-CoV-2 are not harmonised, and different laboratories may obtain different results for the same samples. To address this lack of standardisation, the JRC has developed EURM-014k, a synthetic single-stranded RNA (ssRNA) reference material that includes five target regions of the SARS-CoV-2 genome and part of the human RNase P gene. This CRM has been certified for its RNA identity and copy number concentration. It can be used for method calibration, quality control, and assessment of method performance in reverse transcriptase PCR assays.
EURM-014k is compatible with several WHO-recommended assays and can serve as a positive control for the human RNase P assay, which is used to verify the efficiency of the RNA extraction procedure and the integrity of clinical samples. Furthermore, EURM-014k can serve as a positive control for the JRC-CoV-UCE assay, a novel 'universal' assay that targets ultra-conserved elements of the SARS-CoV-2 genome which are anticipated to remain stable despite virus evolution.
EURM-014k was produced in compliance with ISO 17034:2016 and ISO 33405:2024, ensuring the highest level of quality and accuracy. The material was characterised through an interlaboratory comparison involving eight expert laboratories.
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EURM-014k is provided as a set of three single-use mini capsules and a shellOpener, and can be reconstituted in 100 μL, with a minimum sample size required for one measurement of 5 μL.
The release of EURM-014k is a significant step towards harmonising SARS-CoV-2 detection methods and ensuring the accuracy and reliability of wastewater surveillance (WWS) approaches. This CRM is compatible with existing RT-PCR assays, including the JRC-CoV-UCE assay, and can be used to support the detection of newly emerging variants.