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When Assessing Limits Of Detection (LoD) For In Vitro Diagnostic Reagents, What If LoD Results Differ From Batch To Batch?

2021-10-18

Detection limit (LOD) is an important performance index of in vitro diagnostic reagents. Generally, three batches of reagents are used for LOD research. If the LOD results differ from batch to batch (generally there should be no significant difference), the maximum value or higher value shall be taken as the claimed LOD of the reagent to ensure that all batches of reagents meet the claim.

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