Pre-Analytical Requirements
John H Livesey,* M Jane Ellis, and Margaret J Evans



Summary
Correct test selection: a test must have the potential to alter patient management and have the specificity and sensitivity appropriate to the pretest probability of disease.
Correct dynamic test procedure: dynamic tests may assist diagnosis and protocols must be readily available.
Correct patient preparation: fasting, or other patient preparation, may reduce variability. Clear communication, to both patients and staff, of any such requirements is essential.
Correct sample collection: the tube type (for blood) or container (for urine) must be appropriate for the analyte; there must be sufficient volume, avoidance of venous stasis, contaminants and haemolysis; and adequate labelling.
Correct sample handling: the time and temperature before and after separation, and the centrifugation and separation procedures, must be suitable for the analyte. Accept/reject criteria must be defined.
Methods require thorough evaluation of patient-related pre-analytical factors, and quantification of the effects of time, temperature, haemolysis, anticoagulant type and minimum allowable volume on sample suitability.

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