Policy responses for North Macedonia - HSRM

North Macedonia

Policy responses for North Macedonia

1.5 Testing

The Institute of Public Health is in charge of COVID19 testing through its virology and molecular diagnostics laboratory that was designated in 2019 by WHO as the national influenza laboratory after long years of preparations. The national reference laboratory for virology meets adequate biosafety standards to work with pathogens such in COVID-19. Although the national reference laboratory is adequately equipped with a few trained staff, there is a lack of enough testing kits, swabs for sampling and personal protective equipment (PPE). The reagents donated by WHO Europe have run out after increased testing activities due to a larger than expected number of suspected COVID-19 cases. The overall testing capacity now is about 200 tests per day due to the limited number of trained technicians, but can be stretched to 300 tests a day with potential private sector involvement. The lab technicians work non-stop in 3 shifts.

The testing was initially performed only in the laboratory of the National Public Health Institute. However, upon a Ministry of Health request, other national laboratories are currently being assessed, namely the laboratory within the Veterinarian Faculty and the laboratory within the Pathophysiology Institute and they will be soon be included in the testing process. 

In addition, there are two private laboratories that are being used through out-of-pocket payments by patients who want to be tested without referral, although the Ministry of Health requires confirmation at the national virology lab.

As the Virology Laboratory of the Institute of Public Health is the only reference laboratory for COVID-19 in the country, is the infectious diseases commission recommended not to extend testing capacity to other institutions in order to reduce the risk of spreading infection to health facilities.

The Laboratory for Virology and Molecular Diagnosis at the Institute of Public Health operates in accordance with WHO laboratory testing protocols for COVID-19 with WHO-distributed tests since 12 March 2020.

On 18 March 2020, new COVID-19 testing guidelines were adopted whereby testing is performed only on persons who have symptoms of an acute respiratory infection, or who meet the WHO suspected case definition of COVID-19.  

The contacts of a confirmed COVID-19 case are tested, regardless of whether they have symptoms or not.

Testing is supported by the Association of General Practitioners and nearly 1200 GPs are involved in the identification and early detection of cases, increasing access of citizens to diagnostics by referral to the screening outposts. GPs use the electronic health records platform “Moj Termin” to schedule appointments for testing at one of the 14 testing outlets that take swabs and send them to the national virology laboratory. Any citizen with or without symptoms can call their GP, be checked for symptoms and referred for testing if needed.

On 29 March 2020, the Commission of the Ministry of Health completed the review of all, but one, private health facilities and based on the findings will plan to utilize those capacities as part of the national response to COVID-19. The HIF is developing a model to support this type of collaboration between the public and private health system. On March 30, the assessment of the laboratories in the private sector testing for COVID-19 is completed. The Minister informed that with this collaboration between the public and private health sector the testing capacities will be significantly increased.

Two additional COVID-19 screening outposts are operational in Skopje, Chair and Mlin Balkan policlinics as of end of March. More will be open shortly across the country.

As of 31 March 2020, the MoH mobile teams are designated primarily for older people and will be collecting lab samples/ swabs in their homes to prevent them from leaving their homes and part of the mobile teams will be dedicated to collect swabs from the 8th of September Hospital to accelerate the test results as large number of patients come at this facility for other health services as well.

On 8 April 2020, WHO donated 5000 COVID tests to the Virology Lab of the Institute of Public Health.

As of 12 April 2020, 8,000 tests had been done in the country, which is equivalent to about 4,000 tests per 1 million people; this is the highest testing coverage in the region. At this point, mass testing is not necessary, and only symptomatic COVID-19 cases are being tested, in line with WHO recommendations.

Two additional labs in the Macedonian Academy of Science and Arts and in the Institute of Forensic Medicine will be operational by 19 April, with the testing capacities increased by 50-100 additional tests per day, the health authorities informed on 13 April 2020.

On 13 April 2020, the health authorities informed that 20-30% of the population in Debar, in the areas where the restrictive measures are in place, will be screened using coronavirus antibody tests. The goal is to assess the immunity of the people in that region which would contribute to framing the expectations for the rest of the country once it is decided to use antibody tests nationally. WHO is preparing to scale up laboratory diagnostic capacity.  GeneXpert, a test for COVID-19 developed by Cepheid for their GeneXpert instrument has received an Emergency Use Authorization by the US Food and Drug Administration (FDA) on 22 March 2020. WHO is currently working to negotiate access to this test.

As of 14 April 2020, the preparations of the two additional labs at the Macedonian Academy for Science and Art and the Institute for Forensic Medicine were ongoing. The postmortem testing materials will be analyzed at IFM and the lab of MASA will be designated for patients from health facilities outside of Skopje.

The laboratory at the Macedonian Academy for Science and Arts is operational and it has capacity of 100 tests per day as of 22 April 2020.

Significant increases have been reported in the price of coronavirus test in the private clinic Zan Mitrev . Instead of MKD 1,500, patients will have to pay MKD 3,950 in the future if they want to be tested for Covid-19 in the Skopje hospital "Zan Mitrev Clinic", which has the capacity to test about 300 patients per day. Zan Mitrev Clinic said that the high demand for tests and the shortage of consumables worldwide are the reason why the cost of testing has increased dramatically.

The Secretariat of European Affairs of North Macedonia announced on 7 May to support the Institute of Public Health to increase its testing capacities.

On 8 May, WHO organizeda training course for scaling up national laboratory capacities. The national laboratories in North Macedonia engaged in COVID-19 testing will take part in the course. The objectives of the course are to:
o Update on tests available for COVID-19 testing
o Verification and validation processes
o Recommendations to ensure procurement during scaling up national laboratory capacities for COVID-19
o Recommendations and discussion on training possibilities for scaling up 

A new algorithm for testing, assessment and appointments to be used by primary care doctors is underway as of 5 May 2020. In addition, the targeted number of tests to be performed daily is to be defined. Clusters by age and chronic diseases are planned to be included in future studies to assess the population’s susceptibility to the virus.

Army medical teams will help with coronavirus testing due to the increased workload of the teams that take swabs for testing for coronavirus. The army teams will be incorporated into the already existing teams of the public health centers that are already in the field and will follow on on people who are already in self-isolation.

The President of the Doctor's Chamber of Macedonia (DCM) urged doctors who do not believe in coronavirus to put aside their personal beliefs and act upon the recommendations of the World Health Organization and the country's health authorities. The DCM has documented that some doctors do not believe in the existence of coronavirus and thus do not send patients for SARS-CoV-2 testing and some doctors have publicly announced on their social media profiles that COVID-19 does not exist.

The private hospital Sistina is introducing home-based rapid serological SARS-CoV-2 testing. Mobile teams that will be collecting the samples will be available only in Skopje, every working day from 09:00-11:00. Patients will need to make an appointment one day in advance. 

As of 29 June 2020, the Ministry of Health has procured rapid tests that will be used prior to hospital admission of patients, The results will be issued within 45 minutes which will assist with the triage of patients. The tests are being distributed to the laboratory of Institute of Public Health, Infectious Diseases Clinic and the Clinic for Gynecology and Obstetrics.

As of 3 July 2020, the Health Minister and the Association of Journalists agreed to implement free of charge COVID-19 screening among journalists and media workers. The goal is to test 500 journalists and media workers in the first 3-day phase and, depending on the outcomes, a second phase will be planned. 

As of 27 October 2020, in the Institute of Public Health, a new COVID – 19 testing admission point will be opened with the aim to speed up the procedure for taking tests for Covid-19. The opening of the new testing point will increase the number of tests performed in the National Public Health Institute to 1000 tests per day, which is about 150 tests more than before.  A plan to increase the testing capacities in other testing sites has also been presented, with an aim to achieve a daily number of up to 2000 COVID – 19 tests in the public health institutions.