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In recent decades, the battle for health has been driven by scientific research. The creation of a line of work that transcends conventional genetic recommendations has been immersed in the relationship between genetics, nutrition and pathologies. This new way of working offers a new approach through new ways of intervening that also require updates in both clinical treatments and laboratory-based care.
Laboratory requirements
Molecular biology aims to explain biological phenomena in molecular terms. It integrates various disciplines of knowledge from basic sciences to biology, including biochemistry, physiology, physics and mathematics. It is the most modern branch of biology and medicine. In molecular biology laboratories, an infinite number of methods and techniques are carried out on the basis of nucleic acids. They are performed for diagnostic purposes or for risk estimation in both genetic and non-genetic pathologies.
Molecular biology focuses on the study of nucleic acids (DNA and RNA) and proteins: the two macromolecules of greatest relevance in the functioning of living beings.
Basic instructions
Biological agents
According to Royal Decree 664/1997, a biological agent is defined as “material or its derivatives, including genetically modified material, cell cultures and human endoparasites, susceptible to cause any type of infection, allergy or toxicity”
Biological agents are classified according to their hazardousness. Based on this classification, the necessary protective measures must be taken for activities with exposure to biological agents. Four hazard levels are then established:
- Group I biological agent: unlikely to cause disease in man.
- Group II biological agent: can cause disease in humans. There is effective prophylaxis or treatment, so it is unlikely to spread to the community.
- Group III biological agent: can cause disease in humans and presents a risk of spreading to the community. Effective prophylaxis and treatment is available.
- Group IV biological agent: causes serious illness and represents a serious danger to the worker. With high risk of spreading without the existence of prophylaxis or effective treatment.
Basic material
The basic instrumentation and equipment for a molecular biology laboratory does not involve a very large outlay either technically or economically. The basic instrumentation does not differ much from that required for a standard laboratory.
Refrigerators and freezers are required for the preservation of samples and reagents. Generally, these are very similar to those for domestic use, but probes are added for temperature control. This ensures that the temperature is constant enough to detect possible failures that could damage both the sample and the reagents.
Sample handling is performed with automatic pipettes and disposable tips to avoid any contamination between samples. If the protocol or the sample requires it, it is necessary to work inside laminar flow hoods. To complete the work, small laboratory equipment such as centrifuges, microcentrifuges, thermostatic bath, electrophoresis system and image capture are needed. In addition, to work with DNA, it is very important to know both the quality and concentration of the DNA. Spectrophotometers or fluorometers are used for this purpose.
Thermocyclers
A separate mention is required for PCR equipment. Thermal cyclers or PCR machines perform the temperature cycles necessary to amplify DNA (PCR or polymerase chain reaction). PCR is a fundamental technique in molecular biology.
Environmental conditions
Laboratory conditions must be perfectly controlled since variations in laboratory temperature or humidity can affect the quality of the results. It is important to be able to reproduce your own results and to do so you must avoid any internal or external variables. Most laboratory equipment is precision instrumentation and works within a very narrow range of temperature and humidity.
PPE
Personal Protective Equipment (PPE) is “any equipment intended to be worn or held by the worker to protect him from one or more risks that may threaten his safety or health at work, as well as any complement or accessory intended for this purpose”.
In a molecular biology laboratory, the PPE used protects the skin, eyes and hands. Depending on the reagents used, it is also necessary to protect the respiratory tract when working in fume hoods.
Glasses
Their purpose is to protect the worker’s eyes. There are different types of eyewear from which you should choose the one that best suits your needs.
Screens
These cover the entire face of the worker. In the laboratory, face shields with plastic visors are often used.
Gloves
Its purpose is to protect the skin from contact with toxic, irritating or corrosive substances, as the hands are the part of the body with the highest risk of contact. In addition to chemical products, contact with biological agents must not be forgotten. Gloves are made of different materials (PVC, PVA, nitrile, latex…) and the use of one or the other depends on the risk to be protected.
Gown
The gown protects against the risk of impregnation of clothing with chemical or biological agents.
Other measures
The laboratory must be equipped with measures of action and protection to control any emergency situation. The UNE-EN 15154 standards regulate the installation and operation of showers and eyewashes in laboratories. These equipments must be in areas of free access and properly signposted.
Required accreditations
Accreditations are very useful tools to guarantee the reliability and quality of the analyses performed both in the healthcare sector and in R&D laboratories. Any accreditation must be granted by an accreditation organism external to the company and recognized nationally or internationally.
ISO (International Organization for Standardization) is a non-governmental organization whose function is to develop standards and regulations for industry and commerce. ISO 15189 standard specifies the requirements that clinical laboratories must meet for the analysis of biological samples of human origin. The standard is divided into two parts:
- Technical: describes requirements for personnel, facilities, equipment, procedures, reporting and quality assurance.
- Management: refers to the requirements for the certification of the quality system.
For a laboratory, the fact of having an accreditation means that:
- The staff is qualified and experienced.
- The equipment and infrastructure are adequate and functioning properly.
- Methods and procedures are appropriate, ensuring calibrations and traceability.
- Applies methods for quality control of the entire process.
- The results are certified and accurate.
Legal Aspects
Personal information generated in the laboratory is considered confidential information. Any person having access to this information must be aware of its confidentiality and have signed a confidentiality document.
The information must be processed according to the criteria and procedures established by the Organic Law on Personal Data Protection (LOPD). The data generated may contain health information, so they must be specially protected.
Molecular biology context
The constant innovation in the field of medicine and the volume of existing materials makes training in it a difficult goal to achieve. High quality training is TECH Technological University answer to this need.
As examples of different specialized areas of healthcare, the Master’s Degree in Clinical Genetics and the Master’s Degree in Precision Oncology: Genomics and Big Data are available postgraduate degrees related to the topic of laboratory results and the study of DNA for the use of new treatments.
On the other hand, a complete and updated compendium of learning that will allow the physician to be trained can be found through the Master’s Degree in Genomic and Precision Nutrition.
