On September 4, Hraparak.am website published an article entitled “USD 500,000 was spent from the budget on the production of Armenian tests, but they are not usable.” The article mentions that the tests have not been used so far, and the journalist concludes that the reason is that “The World Health Organization must make a so-called pretest, that is, give a certificate that the Armenian tests are applicable, and meet the WHO standards.” According to our information, Armenia has not received that pretest from the WTO, that is why Armenian tests, even if produced, are not used.”
Despite the circumstance that in the article, Arsen Arakelyan, director of the Institute of Molecular Biology, who leads the Armenian test production process, denies the assertion that the WHO should approve coronavirus tests before use, and assures that the Armenian Center for Disease Control and Prevention has given a positive conclusion, the journalist does not change his mind, concluding that the tests do not meet the standards and are not applicable.
The WHO only publishes guidelines
Let us figure out whether the World Health Organization really should provide a “certificate” to the producers.
WHO’s functions in testing coronavirus laboratory tests are limited to advising and publishing technical guidelines. According to these recommendations, the health authorities of the WHO member states shall carry out testing or ensure compliance with the technical requirements of the tests. It is unclear where the journalist has found information about the WHO “pretesting” coronavirus tests.
The agencies that carry out the expertise of the produced tests are the health authorities of the test producing countries. For example, the expert examination of coronavirus tests in the United States is conducted by the US Food and Drug Administration (FDA). Thus, test manufacturers apply to get a guarantee from that organization before the tests are sent for use. However, in some cases, even without FDA approval, test manufacturers may use coronavirus tests, if they have a special CLIA certificate.
The “certification” of Armenian tests was done by the Center for Disease Control and Prevention
In the first stage of the production of the tests, it was already known that the expert examination of the Armenian tests is carried out by the Center for Disease Control and Prevention of the Ministry of Health.
The tests were performed on the basis of imported test samples. This is how the accuracy of the tests was verified. You can read more about this procedure in the article of the Fact Invvetigation Platform here.
In conclusion, we should mention that the issues of non-application of Armenian-made tests have also been referred to in the past. However, the claim of Hraparak.am that the tests are not used because they do not have a WHO certificate is not true. And the assertion that the tests are not suitable for use is denied in the “Hraparak” article by the spokesperson of the Ministry of Health, who notes that they will be applied soon.