As the spread of COVID-19 continues across the globe, establishing COVID-19 biobanks is the need of the hour. Biobanks serve as an indispensable resource to accelerate COVID-19 research and trials by providing high-quality COVID-19 specimens. For those looking to scale and those planning to set up COVID-19 biobanks, this blog provides a quick guide for the setup, following international standards and guidelines, and for the smooth running of a COVID-19 biobank.
The Centers for Disease Control and Prevention (CDC) provides specific guidelines on how to best collect, handle, and ship COVID-19 specimens. Per the CDC, biorepository personnel must be trained in transporting patient specimens, cultures, or isolates. This is done by providing laboratory personnel on the proper safety, packing, and shipping regulations for Division 6.2, UN 3373 Biological Substance, Category B in accordance with the current edition of the International Air Transport Associate (IATA) Dangerous Goods Regulations (DGR).
Hiring & Training the Staff
When recruiting biobank personnel, it is advisable to consider recruiting individuals with an educational background in biological sciences, biomedical sciences, chemistry, or biotechnology. A sound background enables them to have a prior understanding of organic chemistry, histology, genetics, immunology, molecular pathology, which aids further understanding the dynamics surrounding COVID-19 specimens and working within a biobank. It is also essential for them to be good communicators to be able to clearly explain the specimen procurement protocol and obtain signatures for informed consent forms (ICF) from the patients and(or) their families.
Managing COVID-19 Specimen Life Cycle
Based upon the number of specimens collected and the number of assigned research protocols, biobanks that work 8-hour shifts can employ at least 1 laboratory manager, 1 lead biobank coordinator (which can also assist with administrative duties), 2 biobank coordinators (that can procure and store the specimens), and 1 individual overseeing the finances. The laboratory manager and lead biobank coordinator can work together to conduct audits and laboratory training. When conducting specimen audits, the Laboratory Information Management System (LIMS) proves to be an efficient tool that helps locate the exact placement of each collected specimen as well as maintaining SOPs. All biobank coordinators should be responsible for entering data collected for the protocol he/she has been assigned to. It is essential to ensure the automation of workflows to seamlessly manage a massive influx of COVID-19 specimens.
It is possible for a biobank to be up and running within a week if all laboratory supplies are in place, experienced staff members are trained or hired, and a COVID-19 LIMS is deployed. The staff can be easily trained to use disparate software products, such as a cloud-based LIMS, even if they come with zero or little experience.
Handling COVID-19 Specimens
COVID-19 biobanks store various specimens, including blood serum, upper respiratory specimens, and genotype germline samples. Some research protocols may require COVID-19 biobanks to collect sputum.
Once the specimens are collected, they should be stored immediately within the biorepository. Specimens that can be delivered promptly to the laboratory can be stored and shipped at 2-8°C. When there is likely to be a delay in specimens reaching the laboratory, the use of the viral transport medium is strongly recommended. Specimens may be frozen to -20°C or ideally -70°C and shipped on dry ice if further delays are expected. When biobank coordinators collect postmortem COVID-19 specimens, the CDC recommends collecting nasopharyngeal swab, lung swab from each lung, separate swab specimens for testing of other respiratory pathogens, and formalin-fixed autopsy tissues from lung, upper airway, and other major organs.
Setting Up Safety Equipment
Personal Protective Equipment (PPE) should mandatorily be worn by those collecting COVID-19 specimens. COVID-19 biobanks must provide their staff with appropriate face shields, N95 or higher respirators, gloves, isolation gowns, centrifuge safety cups, and sealed centrifuge rotors.
It is mandatory to decontaminate work surfaces and equipment with appropriate EPA-registered disinfectants along with proper measures to manage laboratory wastes. Ensuring adequate supplies for packing and shipping is mandatory as per IATA Dangerous Goods Regulations.
Additionally, biospecimens collected from suspected or confirmed COVID-19 positive patients should not be stored or opened at workstations, such as cubicles and desks. They should only be processed or handled in BSL-2 or higher laboratories having biosafety cabinets. At any point, specimens should not be handled without hand gloves, as hand hygiene is of the utmost importance when handling COVID-19 biospecimens. Unless hands are visibly soiled, using an Alcohol-based Hand Rub (ABHR) with greater than 60% ethanol or 70% isopropanol is recommended over soap and water in most healthcare settings.
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule allows a covered entity to disclose the Protected Health Information (PHI) of an individual who is infected with or has come in contact with a COVID-19 patient with law enforcement, paramedics, other first responders, and public health authorities, without the individual’s HIPAA authorization in some cases.
However, when collecting and storing specimens in COVID-19 biobanks, all specimens should receive the LIMS barcoded de-identified samples. The LIMS barcode identifier will help when sharing LIMS collected data on specimens consented for research protocols. COVID-19 biorepositories must maintain copies of all ICFs because this protects their entity along with any approved collaborators.
The world has still not seen a flat curve in the number of COVID-19 positive cases. Clinical trials are being run to find a vaccine for the novel coronavirus disease (COVID-19). Numerous COVID-19 biobanks are being set up to satiate the increasing demand for storing, managing, and supplying COVID-19 specimens to clinical testing and research labs. It is, in fact, more than essential today to deploy technology that helps scale COVID-19 biobanking operations and accelerates the process.
The major challenges of COVID-19 biobanks are the safe handling of specimens, automating workflows, following regulatory guidelines, and keeping up with the surging demand for COVID-19 specimens. Thus, it is important to ensure adequate staffing, supplies, and proper training of the staff to prevent hazardous situations. COVID-19 biobanks must also ensure adequate supplies of sanitizers, disinfectant wipes, cleaners, and PPE and ensure their timely replenishment. If any employee comes in close contact with a confirmed COVID-19 patient, he/she must be quarantined immediately for 14 days.
A COVID-19 LIMS seamlessly manages biospecimens and associated metadata, safeguards Protected Health Information (PHI) of patients, helps locate stored specimens, and manages packaging and shipment of specimens while following international standards and guidelines, including ISO 20387:2018, HIPAA, EU GDPR, and ISBER Best Practices.
CloudLIMS, a leading provider of laboratory informatics has launched a preconfigured, rapid deployment COVID-19 LIMS to streamline and automate COVID-19 biobanking operations. Apply for a Free LIMS today to streamline and automate your biobanking workflows.