Preanalytics and Precision Pathology

According to the Personalized Medicine Coalition, there are currently more than 60,000 molecular genetic tests on the market, with 8 to 10 new products entering the market every day.38 Multiplex technologies such as next-generation sequencing for nucleic acids and mass spectrometry for proteins, once residing solely in the research domain, have swiftly moved into the clinical care arena. [...]biospecimens of poor or unknown quality continue to contribute to the overall inefficiency, excessive cost, poor reproducibility, and high rate of failure of translational research, in general, and of biomarker development, in particular.2,54,55 Recent efforts by biobanking experts to address this problem after the fact include the development of batteries of assays for measurands in specimens that are affected by preanalytical factors. Lithium heparin tubes are not suitable for nucleic acid analysis by PCR because lithium heparin is a PCR inhibitor.172,187-189 Volume of Tube Fill: The Optimal Tube-Fill Volume per the Tube Manufacturer's Recommendation Is Advised.- Tube additives are calibrated to provide optimal ratios of blood to additive. [...]in tubes with additives, the tube fill level is an essential quality indicator for the test sample and should be documented at the time of the blood draw.190 Draw Order: The Recommended Draw Order Is as Shown Below (With Consideration to Alterations as Indicated Clinically) and Is Only Applicable if Multiple Specimens Are Being Collected at 1 Draw.-Prioritized Draw Order, First to Last 1. Furthermore, at the time of acquisition, it may not be known whether or not a biospecimen will be undergoing molecular testing, either as part of immediate patient care or in the future. [...]it is prudent and reasonable to treat all patient specimens in a uniform manner that safeguards molecular integrity and ensures their fitness for molecular analysis as a routine part of patient care.