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Validating your ELISA kit

You’ve titred your antibodies and have a good calibration curve, but can you be confident in the performance of your new ELISA test? Here are some of the key validation steps commercial diagnostic companies take before launching a new ELISA test kit.

Stress testing of components
Most ELISA kits can be stored refrigerated. Freezing is generally only recommended for patient samples, and sometimes controls and calibrators. Repeated freezing and thawing of components is discouraged and the user is instructed to aliquot and freeze calibrators and controls where necessary.

Unlike in-house ELISA reagents and plates which are often used the same day as they are made, commercial ELISA kits need to have long shelf lives and show tolerance to the extremes of temperature and humidity that might be encountered during transportation to distributors and customers. All components are stress tested through repeated freeze-thaw cycles, high humidity and raised temperatures at 37C for prolonged periods…

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