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COVID-19 diagnostic standards development partnership

Multiple efforts, commercial, academic, and public-sector, are underway to develop the tools that ensure reliability of the vital COVID-19 testing enterprise. As testing scales up, we have to be confident that test results are right. The JIMB program in Bioengineering, in partnership with SLAC and NIST, is convening a partnership to make sure that the standards, controls, validation tests, and protocols that underpin testing are in place so we can count on test results.

Partners in this “Coronavirus Standards Working Group” include the organizations building the testing technology, the organizations making the standards and controls, the professional societies that represent the scientists and testing labs, the public health agencies, the regulatory agencies, and international standards bodies.

The Working Group is launching by developing an annotated inventory of resources, doing a gap analysis, and conducting international collaborative experiments to evaluate and establish comparability of the variety of control materials and test methods. It is developing an open information repository of validation methods and data. As our knowledge develops we will collaboratively produce the most-needed reference materials, reference samples, and reference measurement methods to underpin an enduring COVID testing enterprise we trust.

Relevant Publications or More Information

Collaborators:

  • Government: CDC, FDA, NIST
  • Non-governmental: WHO, AMP, CAP, AACC, IFCC, MDIC