The rapid spread of coronavirus infection in Ukraine and all over the world prompts to review the existing testing protocols, to expand the capabilities of laboratories, and to look for new ways to identify and treat patients. According to the information announced by the Ministry of Health of Ukraine, an increase in the number of tests for coronavirus is planned inclusive of tests for the antigen of the virus that causes COVID-19. We suppose that will increase demand for such products on the market and demand for a clear understanding of the regulatory requirements for placing the products on the market and putting them into operation.
According to "Standard 1. Organization of anti-epidemic measures and medical care in focal points of SARS-CoV-2 infection" of Order of the Ministry of Health of Ukraine dated 17.09.2020 No. 2122 "On amendments to the Standards of medical care Coronavirus Disease (COVID-19)" it is stipulated that tests for SARS-CoV-2 antigen used for preliminary screening must be verified in the laboratory of the State Institution "Public Health Center of the Ministry of Health of Ukraine" or laboratory centers of the Ministry of Health of Ukraine. The requirement for verification in accordance with the Standards applies only to tests for the SARS-CoV-2 antigen, which are used for preliminary screening.
From our perspective, this requires preliminary verification of tests for the SARS-CoV-2 antigen before the test is put into operation. For several months this requirement for verification of tests was formal, as information materials on verification protocols that must be followed by the laboratories have been under development.
Cratia applied to the Ministry of Health of Ukraine for clarification regarding verification protocols, the possibility of using the manufacturer protocols in the absence of local approved protocols, the number of tests to be provided, and laboratories that have facilities to perform the relevant procedures. To this date, we have not received any response from the Ministry of Health of Ukraine, but answers to these questions are partially provided in the amendments to the Standards dated 09.11.2020.
In particular, Order of the Ministry of Health of Ukraine dated 09.11.2020 No. 2557 "On approval of the amendments to the Standards of medical care Coronavirus Disease (COVID-19)" approved the amendments to the Standards of medical care Coronavirus Disease (COVID-19), which describe the rule on verification of tests in the new edition, namely: the subject of verification is the methodology of investigation of biological material for laboratory diagnosis COVID-19 using tests to identify SARS CoV-2 antigen, which are used for preliminary screening in accordance with the Protocol indicated in the Standard.
The new version of the Standards dated 09.11.2020 changes the subject of verification and provides algorithms for the procedure as compared to the previous rules provided in the Standards dated 17.09.2020. In particular, the purpose of verification of the methodology of investigation is to determine the functional characteristics of the manufacturer methodology, which are confirmed in a specific laboratory. Currently, these laboratories are the laboratory of the State Institution "Public Health Center of the Ministry of Health of Ukraine" and laboratory centers of the Ministry of Health of Ukraine. The latter centers, according to our analysis, include laboratory centers in compliance with the list provided in Order of the Ministry of Health of Ukraine dated 26.01.2018 No. 152.
In order to confirm the functional characteristics of the methodology of investigation defined by the manufacturer using tests for the SARS CoV-2 antigen, which are used for preliminary screening, it is necessary:
- to contact a laboratory (see the list of laboratories above);
- to provide technical documentation confirming that the product meets the requirements of the technical regulations and a declaration of conformity;
- to provide samples of the product for evaluation (minimum quantity of samples: 50 units for tests in patients and 50 units for tests in healthy individuals, 100 units total);
- to confirm at least 2 functional characteristics of the methodology: diagnostic sensitivity and diagnostic specificity;
- verification of the manufacturer method is carried out by checking the diagnostic sensitivity and diagnostic specificity using the confirmatory and new (manufacturer's) methods;
- the diagnostic sensitivity and diagnostic specificity of the methodology are considered to be verified if the parameters obtained by the laboratory are not lower than the corresponding parameters specified by the manufacturer in the instructions for use;
- the protocol of verification of the methodology of investigation is issued based on the results.
We recommend that manufacturers of SARS-CoV-2 antigen tests used for preliminary screening should analyze the verification rules and discuss verification issues with potential users of these tests to comply with the Standards.
P.S.: We remind you of the expiry of the transition period on January 1, 2021, after which the measurement units on the labeling of products placed on the market must be performed using the International System of Units SI. The requirements of the Order of the Ministry of Economic Development of 04.08.2015 No. 914 apply to all products that are put into circulation in Ukraine including medical devices and medical devices for in-vitro diagnostics.
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