Illustration: Swab antigen (freepik.com)Rapid Diagnostic Test Antigen (RDT-Ag) by swab is one way to detect the presence of genetic material or specific proteins from the SARS CoV-2 Virus. This examination method is used for case tracking or screening, including screening carried out when people will travel within the country. The public can obtain rapid antigen test services independently at Health Service Facilities (Fasyankes), in the form of hospitals, laboratories and other health facilities.
The public can obtain RDT-Ag testing services at health facilities conducted by trained health workers. However, the cost of RDT-Ag examination services that apply in health facilities varies greatly, and there is even competition for RDT-Ag examination service rates, especially in a number of health clinics in the capital city, which slams the examination service rates far below the market or the maximum limit regulated by the Ministry of Health's circular letter No. HK.02.02/I/4611/2020 concerning the Highest Tariff Limit for Rapid Antigen-Swab Test Examination. This has raised concerns in the community, especially regarding the safety and quality of the RDT -Ag used in a number of clinics. Actually, the existence of tariff wars or competition to offer cheap service rates can be caused by the law of supply and demand in the market (supply-demand mechanism), where currently the production and/or importation of RDT-Ag products has also increased compared to the beginning of the pandemic. However, it remains the obligation of the Ministry of Health to ensure the safety, quality and benefits of RDT-Ag in circulation, namely ensuring that the product has a distribution license, which means that the product has met the requirements of technical parameters, namely sensitivity and specificity.
The anticipatory step taken by the Ministry of Health is to cooperate with the relevant Provincial Health Office to inspect a number of clinics that provide RDT-Ag testing services to ensure that the products used have a distribution license. So far, the post-market supervision of RDT-Ag products that have a distribution permit have also been routinely carried out through validity testing in 2 (two) laboratories in accordance with the provisions stipulated in the Decree of the Minister of Health of the Republic of Indonesia Number HK.01.07/MENKES/477/2021 concerning the Rapid Diagnostic Test Antigen (RDT-Ag) Validity Testing Laboratory. This supervision aims to monitor and evaluate that the validity of the product still meets the standards required for distribution permits and meets the criteria for selecting RDT-Ag as stipulated in the Decree of the Minister of Health of the Republic of Indonesia Number HK.01.07/MENKES/3602/2021 Regarding Amendments to the Decree of the Minister of Health Number HK.01.07/MENKES/446/2021 Regarding the Use of Rapid Diagnostic Test Antigens in the Examination of Corona Virus Disease 2019 (COVID-19).
In addition, the Ministry of Health has also evaluated and redetermined the Latest Price Standard for Rapid Antigen Tests through Circular Letter Number HK 02.02/I/3065/2021 concerning the Highest Tariff Limit for Rapid Test Diagnostic Antigen (RDT-Ag) Examination as of September 1, 2021. With this latest RDT-Ag examination tariff standard, it is hoped that it can increase public access to RDT-Ag examination services in supporting the achievement of the 3T (Tracing, Testing, Treatment) program.
Thus, things that must be of concern to the public regarding RDT-Ag testing services at Health Facilities, including
- Products used already have a distribution permit
- Health protocols are implemented during service delivery
- Test procedures on patients according to applicable SOPs
If there are health facilities that use RDT-Ag products without a distribution permit, they can be subject to sanctions in accordance with Article 196 in Law Number 36 of 2009 concerning Health. The information on RDT-Ag products that have registered distribution permits can be accessed at the Ministry of Health's infoalkes system (https://infoalkes.kemkes.go.id/) and alkes mobile. [Ni Ken]
Reference:
- Law Number 36 of 2009 concerning Health
- Decree of the Minister of Health of the Republic of Indonesia Number HK.01.07/MENKES/477/2021 concerning the Rapid Diagnostic Test Antigen (RDT-Ag) Validity Testing Laboratory;
- Decree of the Minister of Health of the Republic of Indonesia Number HK.01.07/MENKES/3602/2021 Regarding Amendments to the Decree of the Minister of Health Number HK.01.07/MENKES/446/2021 Regarding the Use of Rapid Diagnostic Test Antigens in the Examination of Corona Virus Disease 2019 (COVID-19);
- Decree of the Minister of Health of the Republic of Indonesia Number HK.01.07/Menkes/4642/2021 concerning the Implementation of a COVID-19 Examination Laboratory
- Circular Letter No. HK.02.02/I/4611/2020 concerning the Limit of the Highest Tariff for the Rapid Antigen-Swab Test.
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