April 08, 2020
The outbreak of novel coronavirus, also known as COVID-19 or Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in December 2019 has resulted in a global pandemic. Clinical researchers across the globe are working on a war footing to find a cure or treatment for the deadly disease. Biobanks provide high-quality biospecimens to accelerate clinical research and trials on COVID-19, enabling researchers to better understand the virulence of the pathogen and to develop a vaccine for the prevention of disease. Some of the common COVID-19 biospecimens biobanks store are nasopharyngeal or oropharyngeal swab, serum, blood, nasopharyngeal aspirate, bronchoalveolar lavage sample, tissue from biopsy or autopsy including lung tissue. Biobanks also facilitate population-based cohort studies that help in estimating the actual seroprevalence i.e., the level of COVID-19 virus in a population, as measured in blood serum, in different areas.
COVID-19 is a high-threat pathogen. Biobanks must take necessary precautions and follow best practices for safe handling, processing, storage, and shipment of COVID-19 biospecimens to minimize health risks to the biobank staff. Some of the best practices biobanks must follow while managing COVID-19 biospecimens are as follows:
Biobanks must take standard precautions when handling COVID-19 biospecimens. Some of the precautions include regular washing and sanitization of hands with sanitizers, having at least 60% alcohol, use of Personal Protective Equipment (PPE), such as laboratory coats, gloves, and surgical masks. Safety glasses or face shields should be used to protect the eyes. Biobanks personnel should use a designated area for donning and doffing Personal Protective Equipment. This area should be ideally away from the workspace to minimize the risk of transmitting the virus and contaminating other samples.
Biobanks should use Class II Biosafety Cabinets for opening containers having COVID-19 positive specimens and for processing them. The Biosafety Cabinets should be equipped with HEPA (High-efficiency Particulate Air) filters that can remove 99.97% airborne particles with a size of 0.3 microns. The HEPA filters remove aerosols generated during specimen processing. The Biosafety Cabinets acts as a physical barrier between the biospecimens and the staff processing them, thereby protecting them from the pathogen. Biobank personnel should regularly decontaminate work surfaces and equipment used for processing biospecimens using disinfectants such as 0.5% sodium hypochlorite solutions.
The waste materials generated from processing COVID-19 specimens are classified as biohazardous waste. Biobank staff should follow the same procedure for disposing of waste generated from COVID-19 specimen processing that they follow for other biohazardous waste.
For long term preservation of COVID-19 biospecimens, biobanks must store them at -70°C or below. Biobanks storing COVID-19 samples should ensure uninterrupted power supply so that the cryo freezers maintain the required ultra-low temperatures for preserving the biospecimens. Proper storage of specimens is important to maintain the virulence of COVID-19 specimens, which is important for clinical research.
Biobank personnel responsible for the shipment of COVID-19 specimens must be trained to pack and ship the specimens as per the regulatory guidelines. The packaging must be done as per the P650 (or Packaging Instruction 650) guidelines. For shipping out COVID-19 specimens by air, biobanks must treat the specimens as 3373 Biological Substance, Category B. The specimens must be shipped following the International Transport Association (IATA) Dangerous Goods Regulations. If a sample is already frozen then dry ice should be used for the shipment of samples. Local transportation should be taken care of by personnel who understand the hazards or characteristics of the package contents. Leak-proof primary and secondary containers should be used for the shipment of COVID-19 specimens.
If a biobank staff member is accidentally exposed to COVID-19 biospecimens, they must seek immediate medical care and must report it to the healthcare authorities. If a COVID-19 biospecimen, for example, blood, is accidentally spilled on a surface, the biobank staff must take appropriate measures as per the biobank's guidelines to minimize the pathogen's transmission risk.
Biobanks must perform a site-specific and activity-specific risk assessment to determine and minimize potential risks. The risks must be assessed based on several factors. Some of them are methods used for specimen handling and processing, the competency of the staff involved in processing COVID-19 specimens, average volumes of specimens received and handled by the biobank on a day-to-day basis, the laboratory equipment and other resources available in the biobank. The risk assessment helps biobanks determine the need for additional safety measures. Only biobanks with the appropriate equipment, trained personnel, and facilities should collect, share, and handle COVID-19 positive specimens.
A COVID-19 LIMS software plays a crucial role in managing biospecimens and associated metadata, safeguarding Protected Health Information (PHI) of patients, locating stored samples, managing packaging and shipment of samples. It also helps manage patient consent and follow Standard Operating Procedures, best practices, and regulatory guidelines such as HIPAA, EU GDPR, and ISO 20387. Additionally, it helps in generating personalized reports of specimens, patients, and studies in a few clicks. Furthermore, a LIMS helps maintain an audit trail, Chain of Custody to regulate the transfer of specimens from one custodian to another, and assign role-based access to protect confidential data, such as PHI.
To contain the spread of the virus, work from home has become the norm and is recommended by various organizations to their employees. A Biobanking LIMS in the cloud helps biobank managers to securely access data via the Internet from their home. This is a big advantage since local and federal authorities are enforcing people to work from home to prevent the spread of the virus. Biobank customers can also place requests for specimens or their storage from the client portal and track the status of the requests in real-time. The cloud service provider takes regular backup of data at disparate locations, eliminating any chances of data loss. If you are managing SARS-CoV-2 or COVID-19 biospecimens, you can apply for a Free LIMS to streamline and automate your biobank workflows.