On May 4, the government and regional authorities agreed a plan to widen COVID-19 early detection capacity as well as improving rapid response for isolating new cases and contact tracing, so as to guarantee a safer transition across de-escalation stages. Hence, the plan comprises the reinforcement of early detection in primary care (by PCR or any other equivalent test), and a closer coordination with the epidemiological surveillance services (https://www.mscbs.gob.es/gabinete/notasPrensa.do?id=4893).
On May 9, a new guidance on surveillance and monitoring states that all suspected cases will have a PCR test (or similar) within the first 24 hours after contacting the health system. On a different note, according to current evidence, rapid antibody tests are not recommended for diagnosis or clinical decision making (https://www.mscbs.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov-China/documentos/COVID19_Estrategia_vigilancia_y_control_e_indicadores.pdf).
After the expiration of the state of alarm, regional health authorities have to guarantee that all suspicious cases are tested by PCR, or by any other analogue molecular technique, as soon as symptoms are known. All public and private authorised labs have to report on the tests performed (PCR or any other molecular technique) on a daily basis (Royal Decree 21/2020 https://boe.es/diario_boe/txt.php?id=BOE-A-2020-5895).
On August 14, in order to prevent a new expansion of the virus within nursing homes and assisted-living facilities, the Interterritorial Council approved the expansion on the frequency and coverage of PCR testing. The new procedure aims to test those new residents entering a facility 72 hours prior to the admission; regular testing to all personnel (at least once each 15 days); testing those employees returning from leave or vacation; and, testing new employees before joining. In addition, visits to residents are limited to just one relative per resident, one hour per day (https://www.mscbs.gob.es/gabinete/notasPrensa.do?metodo=detalle&id=5025).
On September 22, the Public Health Commission approved the use of antigen tests as a diagnostic tool, updating the guidelines for diagnosis, surveillance and control of COVID-19 accordingly. Their use is recommended for symptomatic patients with less than five days of evolution as well as close contacts.
At nursing homes and assisted living facilities, antigen tests will be preferred to PCR testing in case residents or personnel show symptoms and when PCR results are expected to be delayed more than 24 hours. In case of asymptomatic people, PCR is recommended. In turn, at hospital settings, either PCR or antigen tests are recommended, both in symptomatic and asymptomatic patients and healthcare workers.
Finally, antigen tests could be used for population screening purposes in high prevalence areas, if PCR capacity were overloaded (https://www.mscbs.gob.es/gabinete/notasPrensa.do?id=5057; https://www.mscbs.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov/documentos/COVID19_Estrategia_vigilancia_y_control_e_indicadores.pdf).
On December 16, the Conference on Alert Preparedness and Response Plans (Ponencia de Alertas y Planes de Preparación y Respuesta) established that rapid antibody tests were not appropriate for diagnosis of neither symptomatic nor asymptomatic people. As a consequence, Public Health authorities will no longer use antibody testing results in the surveillance and monitoring strategies and physicians have been strongly recommended not to prescribe rapid antibody tests for self-diagnosis purposes (https://www.mscbs.gob.es/gabinete/notasPrensa.do?id=5171).
Laboratory testing for the diagnosis of the SARS-CoV-2 is mandatory in two situations:
● A patient presenting clinical signs of acute respiratory infection who is hospitalized or who meets criteria for hospital admission; and
● A patient presenting clinical signs of acute respiratory infections of any severity who belongs to the health and social care workforce or to any other essential service (e.g. police, military forces).
In addition, laboratory testing may be considered for vulnerable patients with clinical signs of acute respiratory infection regardless of the severity of their condition, and just after an individualized clinical assessment.
Routine diagnostic testing is not being performed in patients with mild acute respiratory infections not included in the above assumptions or in people who have had contact with patients.
When it comes to the procedure, public health authorities in the different ACs have set up testing premises, both in primary care centres and in hospitals. Additionally, primary care coordination and response teams have been set up to assess via telephone or home visit any evolution of the self-isolation patients that advise transfer for testing. Several ACs have also established drive-through testing facilities. Tests can only be requested by any medical doctor, and are approved once public health authorities check whether the patient fulfils the testing criteria described above.
The ACs informed that up to 355,000 laboratory tests for SARS-CoV-2 had been performed until March 22. From that date on, the Ministry of Health had also purchased a set of 640,000 rapid COVID-19 antibodies detection tests and set purchasing orders for other 5.5 million more, including the provision of 4 robots for testing automation (Minister for Health’s parliamentary appearance, March 26 (https://www.mscbs.gob.es/gabinetePrensa/notaPrensa/pdf/26.03260320134953882.pdf; Consumo y Bienestar Social - Gabinete de Prensa - Notas de Prensa).
Until April 5, the testing capacity of the Spanish National Health System was around 15,000 to 20,000 tests per day. On April 5, around one million rapid COVID-19 antibodies detection tests arrived in Spain to be used as a complement to PCR tests in COVIC-19 high prevalence environments, such as hospitals, nursing homes and assisted-living homes (https://www.lamoncloa.gob.es/serviciosdeprensa/notasprensa/sanidad14/Paginas/2020/050420test-coronavirus.aspx).
On April 7, the Ministry of Health published guidance on the utilization of the rapid antibodies detection tests regarding their utilization in hospitals, nursing and living-assisted homes and penitentiary settings. In hospitals and penitentiary settings, in symptomatic patients, rapid tests will be deemed confirmatory if positive (i.e., PCR is not needed); if negative, they will require further PCR testing. In nursing and assisted-living homes, tests will be used to early detect COVID19 cases; just one positive case would suffice to declare the institutional outbreak (https://www.mscbs.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov-China/documentos/Guia_test_diagnosticos_serologicos_20200407.pdf).
From April 13, throughout a Ministerial Order, Regional Authorities are entitled to make use of the testing capacity of those private laboratories located in their regions. Accessing COVID-19 tests will require, in any case, a physician’s prescription and labs are obliged to notify all new cases to the corresponding health authority.
As per the potential implications on pricing abuse and shortage of testing material, the provision entitles Regional Authorities to regulate prices at regional level and it requires private labs to inform on the purchase and provisioning of testing material, in terms of volume and purpose (Order SND/344/2020 https://www.boe.es/diario_boe/txt.php?id=BOE-A-2020-4442).
On April 16, there has been an increase in testing capacity with 40,000 to 47,000 PCRs tests performed daily across the country (930,230 PCR tests had been performed until April 13).
Since April 15, several Autonomous Communities have started using rapid antibodies detection tests to identify new cases in asymptomatic individuals, prioritizing front-line workers and, particularly, nursing and living-assisted home professionals. Information on confirmed asymptomatic cases is being included in the official reports.
On April 23, a total of 1,345,560 tests had been performed, 28.6 tests per 1,000 inhabitants; 77% were PCR tests (22 per 1,000 inhabitants) and the rest were rapid antibody tests (6.6 per 1,000 inhabitants) (https://www.mscbs.gob.es/gabinete/notasPrensa.do?id=4883).
Until April 24, a total of 24 new centres had been accredited to carry out PCR tests. The requirements for a lab to get certified are: self-sufficiency in terms of staff and supplies; ability to safely work with “level 2” samples; availability of biological safety cabinets; and, having staff trained in molecular techniques (https://www.lamoncloa.gob.es/serviciosdeprensa/notasprensa/ciencia-e-innovacion/Paginas/2020/240420-test.aspx).
On May 9, the Ministry of Health released a report on the total number of diagnostic tests performed by the Autonomous Communities until May 7, that is, 1,625,211 PCR tests (34.5 test per 1,000 inhabitants) and 842,550 rapid antibody tests (18 per 1,000 inhabitants) (https://www.mscbs.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCov-China/documentos/COVID-19_pruebas_diagnosticas_07_05_2020.pdf).