Policy responses for Romania - HSRM

Romania


Policy responses for Romania

1.5 Testing

MEASURES INTRODUCED IN 2020

Based on the initial case definition, all people arriving from countries/localities with a high infection rate were screened for COVID-19. All symptomatic cases, people in quarantine and close contacts of confirmed cases have been tested since the beginning of March. Due to the evolution of the epidemic and the community spread of the infection, on March 23rd the National Centre for the Surveillance and Control of Communicable Diseases issued a new testing protocol, based on the EC recommendation at the ECDC advice. The new protocol sets up the priorities of testing as follows:

1. Symptomatic people with a history of international travel;
2. Symptomatic close contacts of confirmed cases;
3. Symptomatic healthcare personnel;
4. Cases of pneumonia without other aetiology, from all age categories and all hospitals;
5. Cases of Severe Acute Respiratory Illness (SARI) without other aetiology, from all age categories and all hospitals;
6. Symptomatic institutionalized people;
7. All patients due to undergo a transplant procedure (asymptomatic), and all hematopoietic stem cell donors before donation.

The updated case definition and surveillance methodology published April 16 and April 28, and on May 14 (see Section 1.4) set testing priorities as follows:

1. Symptomatic persons, including medical staff according to the case definition;
2. Symptomatic close contacts of confirmed cases;
3. Asymptomatic patients before the transplant procedure and donors of hematopoietic organs, tissues and stem cells before donation; patients with transplants of hematopoietic organs, tissues and stem cells undergoing immunosuppressive therapy, before each hospitalization during the post-transplant monitoring period - 2 tests at 24-hour intervals;
4. Asymptomatic patients with immunosuppression in the context of the disease or drug-induced hospitalization - 2 tests at 24-hour intervals;
5. Asymptomatic cancer patients undergoing chemotherapy and / or radiotherapy - twice a month;
6. Asymptomatic cancer patients before surgery or invasive interventions;
7. Symptomatic haemodialysis patients;
8. Asymptomatic haemodialysis patients who have been in contact with a confirmed case, 2 tests at 6-7 days interval between them; during this period they will be dialyzed in separate sessions from the rest of the patients;
9. Symptomatic institutionalized individuals;
10. Asymptomatic pregnant women in quarantine/home isolation or close contact with a confirmed case;
11. Staff of residential centres/long-term care facilities – twice a month;
12. Asymptomatic healthcare personnel who have been in direct contact with a confirmed case, in the 6th or 7th day since the last contact.
13. (Added on May 14th) Asymptomatic institutionalized individuals, upon admission to a residential centre, or return to the residential centre from a health unit or family care.

Public laboratories use the PCR testing method. COVID-19 testing is done based on a referral from a specialist physician. The authorities have committed to increasing national COVID-19 testing capacity. Testing capacity remains low compared to other countries, but facilities are being developed. At the end of February, Romania had just one testing centre; this number has now risen to 35 (see Section 2.1).

The surveillance methodology is regularly updated (June 4, June 19, July 23, August 10, September 18, October 14, October 24, November 18). The update on June 19 made the following adjustments to the priority testing groups:

1. Symptomatic persons, including medical staff according to the case definition.
2. Asymptomatic close contacts of confirmed cases (6-7 days after the last contact with the confirmed case.
3. Asymptomatic patients before the transplant procedure and donors of hematopoietic organ tissues, and stem cells before donation (tested at maximum 48 hours before the procedure); patients with transplants of hematopoietic organs, tissues and stem cells undergoing immunosuppressive therapy, before each hospitalization during the post-transplant monitoring period - 2 tests at 24-hour intervals.
4. Asymptomatic patients with immunosuppression in the context of the disease or drug-induced hospitalization – tested at maximum 48 hours before hospitalization.
5. Asymptomatic cancer patients undergoing chemotherapy (tested at maximum 48 hours before each cure or visit), or radiotherapy (tested at maximum 48 hours before the procedure and each 14 days till the cure is completed).
6. Asymptomatic cancer patients before surgery or invasive interventions (tested at maximum 48 hours before the procedure).
7. Asymptomatic haemodialysis patients (twice a month).
8. Symptomatic haemodialysis patients.
9. Asymptomatic institutionalized individuals (twice a month).
10. Staff of residential centres/long-term care facilities (twice a month).
11. Asymptomatic pregnant women in quarantine/home isolation or close contact with a confirmed case (day 14 if still asymptomatic).
12. Asymptomatic healthcare personnel who have been in direct contact with a confirmed case, in the 6th or 7th day since the last contact.
  
The update from July 23 added medical teams who transport transplant organs as priority testing group (they can be tested every two weeks). The last update, from September 18, notes that all symptomatic direct contacts of confirmed cases should be tested.

Testing capacity has increased to 57 public and private testing centres (see Section 2.1 Physical infrastructure).

From June to September 2020, around 30,000 people will be tested in a national seroprevalence study coordinated by the National Institute of Public Health / the Centre for Surveillance and Control of Communicable Diseases. Asymptomatic people of all age groups who consent will be included in the study, and three to five selected testing centres in each county and the capital city of Bucharest will report the results based on a standardized methodology. In addition, the Bucharest’s City Hall announced a testing programme for around 10,500 city residents sampled from all residential areas and age groups.

References:
https://www.cnscbt.ro/index.php/1574-algoritm-testare-internare-externare-23-03-2020/file 
https://www.cnscbt.ro/index.php/1697-definitii-de-caz-si-algoritm-de-testare-pentru-covid-19-actualizare-28-04-2020-1/file 
https://www.cnscbt.ro/index.php/info-medical/1728-metodologia-de-supraveghere-a-covid-19-actualizare-14-05-2020-2 
https://www.cnscbt.ro/index.php/informatii-pentru-personalul-medico-sanitar/1781-metodologia-de-supraveghere-a-covid-19-actualizare-04-06-2020 
https://www.cnscbt.ro/index.php/lex/1779-ordinul-nr-979-2020-pentru-aprobarea-efectuarii-studiului-de-seroprevalenta-a-infectiei-sars-cov-2-pe-teritoriul-romaniei 
https://www.agerpres.ro/administratie/2020/05/24/firea-maine-vom-da-startul-proiectului-de-testare-de-tip-anticorpi-pe-un-esantion-de-10-500-de-bucuresteni--511136 
https://www.cnscbt.ro/index.php/legislatie_cov/1780-ordinul-nr-978-2020-pentru-modificarea-si-completarea-ordinului-ministrului-sanatatii-nr-807-2020-pentru-stabilirea-atributiilor-in-activitatea-de-testare-in-vederea-depistarii-infectiei-cu-virusul-sa/file 
https://www.cnscbt.ro/index.php/info-medical/1809-metodologia-de-supraveghere-a-covid-19-actualizare-19-06-2020/file 
https://www.cnscbt.ro/index.php/info-medical


MEASURES INTRODUCED IN 2021

The SARS-CoV-2 PCR testing capacity increased from 7 centres in March 2020 to 176 centres at the end of January 2021, which was supported by consecutive ordinances if the Ministry of Health (see Section 2.1. Physical infrastructure).

Although the RT-PCR testing remains the “golden standard” for COVID-19 testing, rapid antigen testing is also performed in healthcare facilities, residential care centres, and penitentiary institutions. Rapid testing is performed only by qualified healthcare staff (public or private healthcare providers, including mobile units and drive-thru points).  Standardized reporting of test results in a dedicated platform and to the county public health directorates in each county is mandatory.

The National Centre for the Surveillance and Control of Communicable Diseases at the National Institute of Public Health coordinates and sets testing priority groups at the national level, periodically updates the surveillance methodology, collects all data (test results) and reports it to the Ministry of Health and other national and international authorities. The 2021 updates (January 4 and February 24) of the surveillance methodology added the rapid antigen tests as an alternative to the RT-PCR tests for some priority groups. For other priority groups, the RT-PCR test is recommended. The priority groups for which the rapid antigen test may be used are:
1. Symptomatic people, including medical staff, according to the case definition.
2. Direct contacts of a confirmed case.
3. Parents or caregivers of children with cancer or COVID-19.
4. Asymptomatic pregnant women in quarantine/home isolation or close contact with a confirmed case.
5. Asymptomatic healthcare staff, direct contact of a confirmed case (5-7 days from the last contact).
6. Staff of residential care centres, long-term mental health facilities and prisons in case of a community outbreak (minimum 3 people) confirmed by RT-PCR testing (the rapid tests can be used to facilitate the early detection of other cases).
7. Asymptomatic institutionalized individuals, including chronic psychiatric patients and inmates, upon admission and four times per month (as an alternative to twice-a-month RT-PCR tests).

Rapid testing is recommended for symptomatic individuals in healthcare facilities with temporarily limited RT-PCR testing capacity or in those situations where positive testing rate is high or very high (over 10%).

Asymptomatic vaccinated individuals are exempted from testing after 10 days from their second vaccine dose; this includes patients with chronic diseases receiving inpatient or outpatient care. The Competent Authority (the National Agency for Medicines and Medical Devices in Romania) did not allow the pharmacies to distribute the rapid SARS-CoV-2 tests, as they are marked “for professional use only” by their manufacturers, but the online commerce is not tightly regulated and tests can be freely ordered online.

Rapid antigen testing for COVID-19 was introduced at schools when they reopened on February 8, 2021. They are administered through the school medical facilities, based on a standardized consent form signed by the parents/caregivers for children under 18 years old. Although the Health Minister declared in February that rapid tests are available for schools countrywide, many rural communities have had difficulties finding medical staff to administer rapid testing, as school medical facilities are not available in all schools.

The genetic sequencing of SARS-CoV-2 from confirmed cases is included in the COVID-19 surveillance methodology by the National Centre for the Surveillance and Control of Communicable Diseases. The methodology recommends a set of criteria for selecting the cases; additionally, only samples with Cycle threshold (Ct) values under 30 should be sent for genetic sequencing. The laboratories that perform genetic sequencing must have standardized working methodologies. The results are sent to the County Health Directorates and the National Centre for the Surveillance and Control of Communicable Diseases.

The Ministry of Health aims to enhance the capacity for the genetic sequencing of SARS-CoV-2 confirmed cases. In February 2021, the Ministry of Health set up a technical committee to assess the national SARS-CoV-2 testing and sequencing capacities to inform further policy measures.

References:
http://www.ms.ro/centre-testare/ 
https://www.cnscbt.ro/index.php/info-medical
https://www.anm.ro/anunt-important-13-11-2020-2/
MoH Order no. 2240/2020 amending MoH Order no. 1829 / 2020 regarding the reporting of the SARS-CoV-2 infection data.
https://www.edu.ro/sites/default/files/ordin%20comun%20nr.%203.235_93_4.02.2021.pdf
https://www.edu.ro/sites/default/files/Formular%20final%20%20exprimare%20consimtamant%20testare.pdf
http://www.ms.ro/wp-content/uploads/2021/02/OMS_NR.94_08.02.2021.pdf