Since October, the state has not acquired any rapid antigen tests for the new coronavirus, although citizens have paid for them in advance from the budget and are forced to do this type of diagnostics in private laboratories.
Some health institutions were left without these tests and had to ask for donations or buy them from their own funds. Although the citizens have already allocated 700.000 euros from the budget for this type of tests for November, due to the lack of promptness of the former Government, many of them are forced to pay for diagnostics at private companies in January as well. The price of this test in private laboratories in Montenegro is 25 euros, while on the market they cost only five dollars.
Two and a half months ago, the World Health Organization (WHO) gave the green light for rapid antigen tests to be used in the diagnosis of the new coronavirus, in addition to PCR tests, which are the gold standard, and the Institute for Public Health (IJZ) announced at the beginning of October that the tests soon to be available in Montenegro.
In October, IJZ bought 20.000 rapid antigen tests from Farmalab for 224.000 euros.
However, the health centers received small amounts of tests, which they used up in a few days, considering that citizens are getting tested more and more and that the number of active cases of coronavirus at one point exceeded 10.000. IJZ told "Vijesti" that in October they acquired 20.000 tests, of which 19.000 were sent to health centers and hospitals. These tests, as stated in the contract between IJZ and Farmalab, cost 224.000 euros.
They said that in March they received 5.000 antigen tests from donations, but that they were of low sensitivity and specificity, so their results were unreliable. They explained that there was a fairly large number of false positives and negatives. "With all that in mind, IJZ gave up their use. Also, IJZ will no longer procure rapid antigen tests, while Montefarm has announced a tender for their procurement in the amount of 700.000 euros," the answer reads.
The IJZ data on the number of assigned tests do not match the data of individual health institutions.
So, for example, according to the statistics of the IJZ, the Beran hospital received 400 tests by December, while the institution announced that they received twice as many.
Tests for November were not provided, Montefarm withdrew the tender
The government only decided on November 6 to divert 700.000 euros from the current budget reserve for 70.000 tests for November, but the procedure has not yet been completed.
The former NKT for Infectious Diseases, headed by the Minister of Health Kenan Hrapović, did not tell "Vijesta" how many rapid antigen tests they received as a donation, as well as whether they used the donated money from the aid account during the covid crisis to buy these and PCR tests, which quantities and to which health institutions they were forwarded. According to data from the coronainfo website, there are more than eight million euros in the NKT account.
Montefarm told "Vijesta" that, based on the Government's decision, they entered the emergency procurement procedure, which will provide 70.000 tests for November.
"The emergency procurement procedure is carried out in accordance with the Law on Public Procurement and the public will be informed in a timely manner about its final result. Planning the delivery of antigen tests to public health institutions is the responsibility of the Institute of Public Health, which also made an estimate of the necessary number of them. "Montefarm is in charge of their procurement and distribution, precisely based on the request of IJZ", the answer reads.
However, shortly after it was announced in the second half of November, the tender was withdrawn. Montefarm did not answer why, but announced that they would call for a new one.
According to the unofficial information of "Vijesti", that institution during the procedure asked the IJZ for clarifications regarding the reliability of certain tests. The IJZ, however, did not answer what was the subject of Montefarma's interest and what was communicated to them from that institution. Only at the end of December, a decision was made according to which the most favorable offer of the company Osmi red - 87.500 tests for 700.000 euros. That company, after the conclusion of the contract, should deliver 20.000 tests to Montefam, and the rest after a month.
Institutions ask for donations, tests used up in five days
Health centers in Tivat and Herceg Novi received small quantities of rapid antigen tests, which is why they were forced to collect money from donations in order to meet the citizens who need to be tested.
The Tivat Health Center told "Vijesta" that they received 140 tests from IJZ. They said that they bought the tests from the donated money in October for 16,94 euros per piece, in November for 12, and in December for nine euros.
The Bar Medical Center received 600 tests for free from IJZ and will not do this type of diagnostics, but only PCR, until Montefarm delivers new quantities.
"Additionally, we ordered 200 rapid antigen tests and 500 media for PCR from our funds, but due to the deficit on the market, 100 rapid antigen tests were delivered to us. We didn't get the tests from donations and we bought 100 antigen tests from our own funds because they were no longer on the market," said the director of this institution, Branka Purlija, and pointed out that the institution has done 700 of these tests so far.
The head of the financial and economic sector at the Pljevlja Health Center, Rajkica Kljajević, said that the institution received 320 rapid tests from the IJZ. She explained that they bought 40 pieces, 20 of them for 10 each, and the rest for 8,5 euros.
The Cetinje Health Center responded that they had received 400 tests from IJZ, but that they had not received any delivery from "Montefarm". The capital of Cetinje donated 300 media for PCR diagnostics and money for 84 rapid tests, and they independently purchased 200 pieces at a price of 12 euros.
The Beran Health Center did not receive any tests from "Montefarm", while they received 550 pieces from IJZ, 50 of which are intended for the needs of the Petnjica Health Center. They said that they did not procure antigen tests independently, because they expect additional quantities through the announced tender. Plav Health Center received 150 tests. The Health Center in Mojkovac said that they received 50 tests each from the IJZ and the Municipality.
The Health Center Herceg Novi IJZ sent 300 antigen tests for the coronavirus, which were used up in five days. That is why that institution acquired additional quantities of tests from its own funds, which were charged to citizens at a price of 25 euros.
In the covid clinics of the Herceg Novi Health Center, since November 20, they have again started doing rapid antigen tests, which were procured with the help of the Municipality and the city companies "Vodovod i Kanalizacija" and "Cistoća".
Health Minister Kenan Hrapović said that he sent a letter to all health institutions in which "it is clearly and precisely said to stop charging for testing because the state has provided money for citizens to receive these services."
And covid hospitals had to buy tests
The situation in Montenegrin hospitals is similar to that in health centers. The Beran hospital, otherwise the covid center for the north of the country, received 200 rapid tests from the IJZ in October and used up 18 by November 105. They said that they ordered an additional 400 tests, at a price of 16.94 euros per piece, and that they did not receive additional amounts from donations. They did not receive a single test from "Montefarm".
Cetinje General Hospital received 200 pieces after addressing the IJZ, although they were not on the list of health institutions to which these tests were to be distributed.
"Since we were informed that the tender is in progress for the procurement of 70.000 rapid antigen tests, it is planned that we need 3.000 tests for our institution. "A dozen rapid antigen tests were performed in the hospital in Cetinje," writes Danilo I in the hospital's response.
500 tests were delivered to Nikšić General Hospital from IJZ.
Bar General Hospital said that they received 200 tests as a gift from the Podgorica Health Center and independently procured as many for 2.200 euros. They explained that they independently acquired 1.300 transport media for samples, at a price of 4.643,20 euros. They received 2000 pieces of these media from IJZ.
Other health institutions, including the Clinical Center (KC), did not respond to the "News" about how many tests they received from the IJZ, how much was spent and whether they bought additional quantities and procured through donations.
The "Vaso Ćuković" Special Hospital in Risno said that they received 100 rapid tests from the IJZ, while they did not receive a single one from "Montefarm" or from donations.
"Due to the shortage, and at the same time the increased need for use, we bought an additional 100 sets of rapid antigen tests, at a price of 11 euros plus VAT, per test. I would like to mention that from October 30, in addition to these rapid antigen tests, viral transport media for PCR diagnostics are also purchased from hospital resources, at a price of 3,75 euros for one VTM, which, until then, was distributed by the IJZ," said the head of epidemiology services of Dr. Slađana Zgradić. Bjelopoljska Hospital received 400 tests from IJZ.
While the state waits, private individuals are testing
PCR testing for the new coronavirus is exclusively done in the IJZ, but also in two private health institutions (My Lab from Podgorica and Dr. Zejnilović polyclinic from Bar), based on the contract with the Health Insurance Fund. Namely, in a situation where the IJZ cannot complete the analysis of accumulated samples, they are forwarded to two health institutions, and the state pays them the test result at a price of 51 euros.
Citizens can also do a PCR test on their own initiative at private companies, but in that case they will pay 80 euros.
The records of those infected with the new coronavirus also include those with a positive rapid antigen test for the coronavirus, which was performed on a private individual.
"Based on the previously adopted testing strategy, the result of the rapid antigen test has the same diagnostic and epidemiological significance as the result of the PCR test, so the results are included in the section of the state that the Institute communicates on a daily basis," the IJZ wrote in the reply.
Many private laboratories perform these tests. Epidemiologists claim that the PCR test is still the gold standard, and that a negative result of a rapid antigen test in people with symptoms of the coronavirus should be taken into account.
The sensitivity of the tests is about 57 percent
"Rapid antigen tests for the new coronavirus are significantly cheaper and faster to perform than the PCR technique, which is the gold standard for detecting viral RNA. However, research already shows that they have a lower sensitivity than was announced", epidemiologist Milena Popović Samardžić told "Vijesta".
She explained that according to some research, the sensitivity of rapid antigen tests is around 57 percent. "In practice, this means that out of 100 infected people, the rapid antigen test will register only 57 people as positive, while 43 people will be declared false negative," said Popović Samardžić.
She said that the sensitivity of tests from different manufacturers also varies.
"The manufacturers themselves declare sensitivity between 83 and 97 percent. For example, the WHO has set a requirement for a minimum sensitivity of 80 percent. The European Center for Disease Control (ECDC) conducted a meta-analysis that included nine types of rapid antigen tests and measured their sensitivity compared to PCR between 29 percent, which is extremely low, and 93,3 percent, which is extremely good," he claims. Popović Samardžić.
She emphasized that the specificity of these tests, unlike the sensitivity, is high.
"And this means in practice that if the test is positive, there is little chance that it is a false positive." We can rely on a positive result of the rapid test in a high percentage, which is very important for the daily work of hospitals and health personnel during the triage and reception of patients. The result of the test itself is also influenced by when the test was performed. It is preferable to do it in the first five days after the onset of symptoms, when the number of copies of the virus in the nasopharynx is high," she explained.
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