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Various factors may affect the test results, including changes of IA reagent batches, variation in the performance of the instrument (if applicable), the operator's processes and factors contributed by the environment [9-11]. A QC process has been implemented in many blood screening laboratories to monitor the consistency of IAs used to screen for TTI. There is evidence that some of the measures and principles of QC commonly used in clinical chemistry, such as an assumption of commutability of the QC result with the patient's sample results, may be less relevant in serological testing [12-16].

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