Personalized medicine is experiencing unprecedented growth as its potential for revolutionizing human health and quality of life is revealed. Sample collection is an important step within the workflow of each personalized test. Test developers often perform initial feasibility and development studies using fresh samples—saliva from lab partners, blood from the phlebotomist down the street. Research is conducted, and tests are developed and verified using samples from right next door.
Samples are often collected and processed within a very short time and without the introduction of any environmental stresses. A saliva sample from your lab partner, however, has a very different history than a patient sample that has been shipped from Florida to California, through Arizona.
This patient sample undergoes environmental stresses such as:
- Temperature excursions
- Extended post-draw time
Samples experience many of these environmental stresses, and more, in clinical trials and beyond. The journey is a far cry from the sheltered upbringing of local samples. Environmental stress is the major factor contributing to test failure. Samples predisposed to stresses can have dramatic effects on results.
Take a look at the figure in the following case study. This table details failure modes for blood collection tubes that stabilize cell-free DNA—a particularly important analyte for personalized medicine:
Failures due to interference or environmental stress, for instance, can cause multiple types of failure outputs.
For the technician running the test and the clinician interpreting the results, there is no way to know what has gone wrong (sample rejected/no call). Many times, one cannot even tell whether something has even gone wrong (false positive/false negative). Significant time can be wasted mistakenly reworking an assay, chasing unwarranted technical modifications, drafting new protocols, or even withdrawing applications completely.
93% of errors encountered within the entire diagnostic process occur in the pre-analytical phase—an alarming statistic. Although the test analysis can be perfect, the final answer may still be wrong due to these pre-analytical variables, which are often not incorporated into the development of the test.
The moral of the story? Don’t waste resources, time, and money. Incorporate real-world environmental stress testing and conditions earlier in feasibility testing and development.
To find out how Biomatrica can save you from pre-analytical failure, click here!