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
SARS-092021-v01
©2021 American Type Culture Collection. The ATCC trademark and trade name, and any other trademarks listed in this publication are trademarks owned by the American Type Culture Collection unless indicated otherwise. ddPCR is a trademark of Bio-Rad Laboratories, Inc. These products are for laboratory use only. Not for human or diagnostic use. ATCC products may not be resold, modified for resale, used to provide commercial services or to manufacture commercial products without prior ATCC written approval.
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