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IVD Reproducibility White paper

IVD Reproducibility Whitepaper

4 critical questions IVD manufacturers should ask when selecting a lab testing partner for reproducibility studies

This whitepaper explores 4 critical questions IVD manufacturers should ask when selecting a lab testing partner, along with Quest’s responses. 
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Many IVD manufacturers know Quest Diagnostics as one of their largest customers. In fact, as the largest diagnostic lab in the country, we utilize instrumentation from nearly every IVD company in the market.

When IVD manufacturers develop new assays on their instruments, they need to perform reproducibility studies, typically with a minimum of 2 external lab partners, to demonstrate that a test is robust and reliabiliable, and demonstrate its consistency in use by other labs when performed with the same or similar instrumentation, methods, and conditions.

This whitepaper is free and can be downloaded and read at your convenience.

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