4.2.1. National Microbiology Center (CNM)
The National Microbiology Center (CNM) has the specific mission of providing scientific and technical support to the General State Administration, the Autonomous Communities, and the Spanish National Health System (SNS) in the field of infectious diseases (ID). Its activity is based on prevention and control, diagnosis, advice and research in this field. One of its main strengths is the ability to combine biomedical research with quality support activities for the SNS in such a way that they reinforce each other.
Highlighted activities
● The key role of the CNM in the fight against the COVID-19 pandemic during 2020, with different interventions adjusted to the needs of each phase of the evolution of the disease in our country. In the first weeks, the CNM fine-tuned the methodology for the molecular diagnosis of this new disease and confirmed or ruled out the diagnosis of the first real and suspected cases. In the middle of the first pandemic wave, the CNM undertook an emergency reorganization of its capacities to support the diagnostic needs of the National Health System for COVID-19. Simultaneously, validation activities were initiated for commercial PCR prototypes developed by Spanish companies, as well as for different serological techniques for the detection of specific SARS- CoV-2 antibodies, with the aim of increasing diagnostic capabilities at the national level. Culturing the virus to support different research projects and to establish a virus bank with the different circulating variants, as well as complete sequencing of their genomes have also been key activities in 2020, which will reach their full development in 2021. The CNM has been actively involved in the four rounds of the National Sero-epidemiological Study ENE-COVID-19 by coordinating the microbiology laboratories and carrying out the serological determinations. The CNM has promoted, designed and coordinated validation studies of rapid antigen detection tests for their incorporation into the national diagnostic strategy for SARS-CoV-2 infection.
● Interventions of the Rapid Response System (RRS) of the CNM in alerts activated by the health authorities, and also at the request of the RE-LAB.
In 2020, it was actively involved in SARS-CoV-2 diagnosis by providing support to the Respiratory Viruses Laboratory, and in the establishment and coordination of the essential working groups formed for SARS-CoV-2 diagnosis in the CNM COVID-19 Operation during the State of Emergency. It also participated in 7 alerts related to the diagnosis of viruses causing Hemorrhagic Fevers and 1 of bioterrorism alert due to suspicion of Bacillus anthracis spores.
● Characterization of the first outbreak of West Nile virus (WNV) detected in humans in Spain. Seventy-seven cases were reported (40 confirmed and 37 probable): 71 in Andalucía and 6 in Extremadura. Neurological symptoms were present in 93.5% of the cases and 94.8% required hospitalization.
More than 300 groups of samples of Culex modestus, C. perexiguus and C. pipiens mosquitoes from the Doñana Biological Station, captured in 15 localities in the provinces of Sevilla and Huelva, were also analyzed. The characterization of the outbreak, conducted by the CNM Serology and Arbovirus laboratory, consisted of serological confirmation of human cases and analysis of the virus genome by complete sequencing in human and mosquito samples.
● The use of massive sequencing in the study and surveillance of outbreaks, in accordance with the recommendations of the European Center for Disease Prevention and Control (ECDC). In 2020, progress was made with the technological development activities of the previous year and these were implemented for the characterization of viruses such as West Nile, SARS-CoV-2, Dengue, Crimean Congo, Chikungunya, Toscana, Rabies, Enterovirus, Measles, Mumps, Hepatitis A, E, C and D, bacteria of the genera Francisella, Klebsiella, Pseudomonas, Haemophilus, Acinetobacter, Serratia, Streptococcus, and fungi of the genera Aspergillus and Candida.
● Coordination and implementation of the National Network of Laboratories for the surveillance of resistant microorganisms (RedLabRA).
● Expansion of the quality management system, based on ISO 15189, 17025 and 9001 standards, to 19 more tests and 3 more Units, totaling 171 tests and 21 Units accredited by ENAC, in addition to the services certified by AENOR. More importantly, a flexible scope of accreditation was obtained for the whole system, which authorizes, within this scope, the incorporation of new tests or modifications of tests to the accreditation without requiring prior evaluation by ENAC. The CNM is the only accredited body in Spain with a flexible scope of accreditation for its entire set of procedures.
Scientific and technical activities
● The scientific and technical activities of the CNM cover the following topics: RRS in biological alerts, scientific and technical advice to the SNS, service portfolio for microbiological diagnoses, study and control of outbreaks, microbiological surveillance programs, and participation in research networks and projects.
● The CNM operates 25 Microbiology Surveillance programs relevant to Public Health, which are reviewed and renewed annually. This surveillance allows us to become aware of evolutionary patterns, study the circulating clones and detect early changes in trends, both in Spain and as in comparison to the rest of the European countries. This knowledge sets the basis for the implementation of health measures that favor the control and prevention of infectious diseases.
● The CNM service portfolio consists of 370 techniques for diagnosis and/or reference of infectious diseases.
● In 2020, 123,942 samples/strains associated with requests for diagnosis and/or reference were studied, and 160,694 tests were done. In addition, molecular characterization of a total of 63 outbreaks produced by different pathogens was completed.
● In 2020, 85 research projects and 36 agreements were active. In addition, the CNM participated in 2 CIBERs and 9 RETICS, and coordinated one of them.