Reliable Diagnostic Tools Depend on Credible Reference Materials
미국 FDA (The US Food & Drug Administration)는 SARS-CoV-2 분자 진단 테스트 제품을 개발하는 제조사들에게 validation study를 진행할 것을 권고 하고 있습니다. 이에 ATCC에서는 COVID-19 진단 제품 및 임상 연구를 지원하기 위해 아래와 같이 다양하고 신뢰할 수 있는 reference materials을 제공합니다.
The highly pathogenic nature and transmission dynamics of SARS-CoV-2 has necessitated the availability of rapid, robust detection methods to ensure that infected individuals are treated in a timely manner. For commercial manufacturers developing SARS-CoV-2 molecular diagnostic tests for emergency use, the US Food & Drug Administration (FDA) has provided recommendations for validation studies to be conducted. To support this critical research, ATCC provides a variety of authenticated and clinically relevant heat-inactivated preparations, live strains, and molecular standards for evaluating limit of detection, inclusivity, and cross-reactivity.
Explore our Portfolio
Our extensive collection includes a variety of viral and non-viral strains and molecular standards representing species recommended by the FDA for SARS-CoV-2 molecular diagnostics development.
» SARS-CoV-2 reference materials
» High priority pathogens from the same genetic family as SARS-CoV-2
» High priority organisms likely present in respiratory specimens
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