What are the criteria of acceptance for the calibration curve on Phadia 250?

What are the criteria of acceptance for the calibration curve on Phadia 250?




This is the answer of Peter Boss, Product Specialist in Uppsala

When it comes to the acceptance criteria for the calibration curve and the curve controls it is not easy to give a straight answer by giving some numbers. The values differ between the different ideal curves of the different methods and even between different calibrator points. Most important when checking the curve is to make sure that the shape is good but there are several other parameters that are controlled.

First the response of all calibrator replicates is checked against upper and lower response limits. These limits are wide and will flag the most extreme outliers. In a second step curve shape is controlled, how each calibrator replicate lies compared to the other calibrator replicates. This is done by calculating the natural logarithm for the quotas between the calibrator replicates and an ideal-curve. The ideal-curve is the expected response for that method. In a third step for each calibrator point the variation between the two calibrator replicates is checked.

An established calibrator curve is checked by using curve controls where the response of these curve controls is compared towards inner and outer limits. The inner limit is set as 2.2*SD and the outer limit as 3.5*SD.

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As in all diagnostic testing, the diagnosis is made by the physican based on both test results and the patient history.