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What is needed for the Longevity Test to pass CLIA requirements as a clinical test?

April 26, 2017CLIA clinical longevity needed pass requirements Test

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What is needed for the Longevity Test to pass CLIA requirements as a clinical test?

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Method validation must be done using an already approved Predicated Device or a true clinical standard. However, there are no predicated devices approved for lipoprotein particle size determination and no lipoprotein particle size standard is currently approved.