AmpTec as GMP-manufacturer of Positive control IVT RNA for European Commission supporting reliable COVID-19 diagnostics in the EU
The European Commission has announced the release of a universal COVID-19 positive control IVT RNA called EURM-019 to facilitate the quality control of the detection of SARS-CoV-2 in the testing laboratories.
EURM-019 has been manufactured by AmpTec GmbH, Hamburg (DE) in compliance with ISO 13485, including regulations of FDA CFR Part 820 (cGMP manufacturing). EURM-019 is fully compatible with the official WHO recommended methods applied in the EU, in Asia and the USA to detect the presence of SARS-CoV-2. The material can also serve to benchmark and validate the numerous test kits based on RT-PCR currently developed worldwide.
The EURM-019 is available via weblink and can also be ordered by email to jrc-rm-distribution@ec.europa.eu
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