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What are the QC requirements for release of the test cartridges?

April 26, 2017cartridges QC release requirements Test

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What are the QC requirements for release of the test cartridges?

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The archived curve is determined, as mentioned above, with acceptability requirements of <25% Coefficient of Variation between replicates and a Correlation Coefficient (R) of = 0.990. Recovery of the spiked values in the potency verification phase must be within 50% to 200%.