Clinical Researcher—December 2020 (Volume 34, Issue 10)

PEER REVIEWED

Dr. Dina Avery

 

No one was prepared for the significant impact COVID-19 is having on global healthcare and biobanking operations. Once COVID-19 arrived across the world, few hospitals and biobanks were fully ready for the influx of infected patients and high death rates associated with the virus.

COVID-19 has caused global biobanks to purchase more personal protective equipment (PPE) in order to protect their employees, and even employees had to be monitored closely for possible COVID-19 symptoms. Biobanks had to communicate and search globally to order needed supplies to collect and store specimens rapidly. They also had to become innovative in their practices to accelerate digital communication to healthcare facilities, regarding the number of patients being tested and to communicate each patient’s results.

For these and other reasons, COVID-19 has provided a vivid example of why and how biobanks are crucial to advancing clinical trials involving vaccine development and longitudinal studies involving outcomes data.

COVID-19 Biobanking, LIMS, and Regulatory Concerns

Virtual biobanks are now essential, especially since globally there were 43,341,451 confirmed COVID-19 cases and 1,157,509 deaths due to the virus as of October 27, 2020.{1} According to the Centers for Disease Control and Prevention (CDC), the digital tools being utilized to capture routine health data during this pandemic include District Health Information Software (DHIS2), the Surveillance, Outbreak Response Management, and Analysis System (SORMAS), Go.Data, Open Data Kit, Epi Info, CommCare, KoboToolbox, and Excel.{2} Laboratory Information Management Systems (LIMS) are being widely utilized among biobanks located in North America, Europe, China, Japan, Southeast Asia, India, Central America, South America, and elsewhere.{3}

No digital tool will be effective without the needed data being stored in LIMS. Global biobanks are extremely useful during the current pandemic because they enable global researchers to access source material and data needed to perform clinical research and trials, irrespective of the actual geographical location of the COVID-19 specimens.{4} This aids researchers’ in-depth studies of COVID-19, as they seek to develop better treatment options and vaccines to irradicate this virus.

Since travel to and from various countries is limited during the pandemic, it is necessary to utilize data-sharing solutions to review data and outcomes from diagnosed COVID-19 patients. Global biobanks working within the same consortium must communicate and narrow down the data to be collected via a questionnaire by the biobanking employee. It is vital to collect each diagnosed patient’s pathology results, medical history, symptoms, and other needed outcomes data. The collected data from each specimen can be entered into a database such as LIMS.

LIMS will definitely allow global biobanks to improve workflows by managing sample collection, sample distribution, patient scheduling, test reporting, and data analysis. Global biobanks utilizing LIMS must follow international regulatory guidelines issued by the United National Educational, Scientific, and Cultural Organization’s (UNESCO’s) International Declaration on Human Genetic Data, which provides principles related to collecting, processing, and storing human proteomic data and genetic data.{4}

Additional guidances are provided by the International Society for Biological and Environmental Repositories (ISBER), Clinical Laboratory Improvement Amendments (CLIA), International Organization for Standardization (ISO) 15189:2021, and the Health Insurance Portability and Accountability Act (HIPAA).{4,5} Biobanking employees must be trained by their management team in reviewing these regulatory guidelines to maintain compliant and efficient quality management systems and biobanking practices.

Risk Management

Biobanks have become innovative by streamlining processes to meet the public health demand. We see more biobank and laboratory employees working in outdoor locations due to the number of daily COVID-19 tests being conducted. The demand for biobanking employees is continuously increasing because they are needed both at these sometimes remote locations and within the regular facilities.

Many students, employees of large organizations, medical professionals, and others are now required to undergo regular COVID-19 testing, even when not showing any signs of the virus. Specimens are even collected from patients already hospitalized with COVID-19. This alone has increased the labor force needed to maintain efficient biobanks.

No matter where a biobank is located, everyone involved in it must practice effective risk management strategies. Biobank employees must safely handle all fresh and frozen biospecimens as infectious materials, which minimizes potential exposure to those collecting and transporting them. Appropriate, safe handling practices also protect the general population.{6}

Further, it is required that all biobanking employees wear PPE and have the necessary equipment to process and store the collected specimens within a sterile environment. International Air Transport Association (IATA) Dangerous Goods Regulations provide guidance on packing and shipping specimens.{7} Environmental Protection Agency–registered disinfectants must always be readily available and proper sanitation protocols must be followed.

Conclusion

The COVID-19 pandemic has increased the money generated by biobanks. The biobanking market is expected to generate $49.46 billion annually by 2026.{8} As a result, the LIMS market is expected to reach $896.8 million annually by the end of that same year, compared to $601.7 million generated in 2019.{3}

Due to large number of clinical trials related to COVID-19, biobanks are essential in collecting and storing biosamples such as plasma, serum, DNA and RNA, clinical data, and genomic data. Researchers want to know more than just if a specimen is positive or negative for COVID-19. Collected data related to each COVID-19 specimen will allow researchers to develop evidence-based strategies, design treatment protocols and predictions based on precision medicine, and share lessons learned.

No one can really predict what is ahead globally, due to the predicted second wave of the pandemic and the unknown effectiveness of future vaccines to be distributed globally. However, biobanking employees are essential workers and their role is continuously evolving since COVID-19 is a new virus. It is imperative for biobanks across the globe to continue to communicate, streamline processes, learn from each other, and work together with other medical professionals toward improving the relevance of their contributions to scientific research and fostering a sustainable network expansion that will lead to novel COVID-19 biobanking strategies.

References

1. World Health Organization. 2020. WHO Coronavirus Disease (COVID-19) Dashboard. https://covid19.who.int/
2. Centers for Disease Control and Prevention. 2020. Guide to Global Digital Tools for COVID-19 Response. https://www.cdc.gov/coronavirus/2019-ncov/global-covid-19/compare-digital-tools.html
3. Market Watch. 2020. Global LIMS Market Size 2020 Trend and Opportunities, Market Share, Analysis, CAGR and Value Chain Study, Showing Impressive Growth by 2026. https://www.marketwatch.com/press-release/global-lims-market-size-2020-trend-and-opportunities-market-share-analysis-cagr-and-value-chain-study-showing-impressive-growth-by-2026-2020-09-03
4. Shonali P and Chatterjee MK. 2020. Data Sharing Solutions for Biobanks for the COVID-19 Pandemic. Biopreservation and Biobanking. https://doi.org/10.1089/bio.2020.0040
5. CloudLIMS. 2020. Deploy in Less than a Week: Preconfigured COVID-19 Testing, Research and Biobanking Workflows Using CloudLIMS, an in the Cloud COVID-19 LIMS. https://cloudlims.com/industries/covid-19-lims-software.html
6. Lankes HA and Makhlouf H. 2020. Biospecimens Collection During the COVID-19 Pandemic: Considerations for Biobanking. American Journal of Clinical Pathology. https://doi.org/10.1093/ajcp/aqaa171
7. Therapak. 2020. Category B and IATA Packaging. https://therapak.com/catalog/specimen-shipping-systems-iata/category-b/
8. Globe Newswire. 2020. Biobanking Market to Reach $49.46 Billion by 2026; Recent Breakthrough Concepts Have Indicated Potential in Covid-19 Vaccine, Says Fortune Business Insights. https://www.globenewswire.com/news-release/2020/06/18/2050309/0/en/Biobanking-Market-to-Reach-49-46-Billion-by-2026-Recent-Breakthrough-Concepts-have-Indicated-Potential-in-Covid-19-Vaccine-says-Fortune-Business-Insights.html

Dr. Dina Avery, (dvavery@uab.edu) is an Assistant Professor and Associate Scientist in the School of Health Professions at University of Alabama at Birmingham.