Biospecimen Collection and Extraction Processes
Biospecimen collection and extraction processing is the step describing the way donor samples are collected from the donor-source, preserved, labeled, and then stored or delivered. Human biospecimens are usually obtained from a patient for a certain test or diagnostic procedure. In some cases, patients give advanced permission for more tissue to be taken than needed for the purposes of research. Consequently, it is not uncommon for biorepositories to store large quantities of frozen or FFPE tissues taken from donor patients and designated to different areas of research. (1)
Is There a Special Process of Retrieving Biospecimens?
The receipt or retrieval of biospecimens is handled by dedicated laboratory professionals often referred to as specimen processors. The laboratory staff at Geneticist works under a strict set of standard operating procedures (SOPs) that are commonplace in our industry. We find that by incorporating SOP’s and appropriate safety methods and procedures, we are able to better protect the viability of the specimens housed in our biorepository.
Specimen processing practices involves bringing into play appropriate handling guidelines set forth by laboratory professionals and regulatory agencies such as the CDC. The function of a biorepository is to facilitate the cycle the donor specimens have to travel through and arrive stable enough to be used in research or diagnostic capacities. Additionally, we do take into active note the requirements the IRB places on existing versus perspective samples and how it relates to clinical studies. (1) As a result, our biorepository maintains strict adherence throughout the entire cycle of specimens handling. (1) (4)
Is It Difficult to Avoid Specimen Contamination?
Handling specimen donor samples does require a high level of acuity. A laboratory personnel member must be trained specifically to handle specimen collection and processing duties. Once the specimen is removed from its original environment, the risk of contamination is a real possibility. Hence, the process of specimen extraction is an important component in maintaining the integrity of the sample.
Specimen collections can involve a variety of different scenarios, especially with varying types of tissue samples and biofluids such as:
Plasma
Urine
Saliva
Stool
Whole Blood
Hair Follicles
A dedicated area or space is often delegated for the strict purpose of assisting the investigator to collect donor samples. Those samples then either go on to specified research designations or to other to long-term bio-storage.
Factors that can alter the stability of a specimen sample include:
Temperature changes
Faulty preservation standards
Toxic Exposure
Time – (Handling, Transport, Processing, Exposure)
Type of Anesthesia
Field Contamination
Preanalytical Variables – Preparing Biospecimens for Use
Preparing the biospecimen for testing is a marriage of quality control and error-free methodology. Any variances with regards to the sample can affect the performance of the testing performance of the assay. Specimen handling is critical so as to avoid changes in the molecular structure of the sample. It is cited in a government article that as much as $28 Billion is spent each year on irreproducible research. This translates to inconsistencies in specimen management. (5)
Consequently, much attention is paid in the areas of specimen handling time, storage temperatures, size, and type. There is a myriad of variables that contribute to the biospecimen process as a whole. Before a sample can be stored for use in other capacities, there is a series of processes in which a sample must undergo prior to the analytic process.
What Are the Some of the Ways Human Biospecimens Are Used?
Whether the tissue extracted is needed for diagnostic reasons or for storage, the practice of obtaining donor samples is the cornerstone of drug discovery and the study of advanced disease. Researchers commonly use FFPE samples, frozen tissues, and other biospecimens in various scientific modalities. The use of human tissues in clinical studies has contributions to just about every area of medicine, advanced disease, and oncologic studies. (6) (7)
FFPE is one most common types of biospecimen samples used in a specific modality referred to as IHC or immunohistochemistry. These IHC applications are used for studying advance disease characterizations and aspects in the fields of hematology, immunology, Alzheimer’s research, and comparative studies. (6)
Preparing an FFPE involves preserving the tissue in a formalin-formaldehyde derivative and then fixed onto a slide. The slides can represent the isolation of a protein, RNA, DNA, or rare tissue types on the same assay for comparative views and analytical purposes. The general nature of the FFPE is a preservation by which it is favored in many circles because of the longevity and versatility of sample use.
Frozen tissues also are represented well in research. They are used for examining cell structure, type, and mechanism of action. (9) It is important to note that all human tissues or specimens are somewhat volatile. In the scientific community, there are noted differences between the specific preferences of FFPE tissues or frozen tissues – especially in terms of their long-term storage capabilities. Geneticist provides both types and any requested customizations.
References and Further Reading:
1. [Online] https://bios.ucsf.edu/what-are-human-biospecimens.
2. [Online] https://irb.ucsf.edu/research-using-human-biological-specimens#common.
3. [Online] https://biospecimens.cancer.gov/bestpractices/to/bcpsrd.asp.
4. [Online] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3995361/.
5. [Online] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5073593/.
6. [Online] https://www.ncbi.nlm.nih.gov/pubmed/21347257.
7. [Online] https://www.cancer.org/treatment/understanding-your-diagnosis/tests/testing-biopsy-and-cytology-specimens-for-cancer/what-happens-to-specimens.html.
8. [Online] https://www.ncbi.nlm.nih.gov/pubmed/30113239.
9. [Online] https://www.nature.com/articles/srep39394.
