The Indonesia Ministry of Health issued an announcement No. FR.01.01 / 3 / 0139A / 2021 on February 15, 2021. The announcement regulates the Rapid Diagnostic Test of Antigen (RDT-Ag) Covid-19 which has been approved by the Indonesia Ministry of Health and require further validation test.
The requirement of imported RDT-Ag which is exempted to apply for further validation test is RDT-Ag must fulfill recommendations from one of the following:
a. WHO Emergency Used Listing (EUL),
b. US-FDA Emergency Used Authorization (EUA),
c. European Medicine Agency (EMA),
While for local RDT-Ag only if the device has sensitivity ≥ 80% and a specificity ≥ 97% (evaluated in the acute phase) determined from the test done by the National Institute of Health Research and Development of the Ministry of Health or an independent institution designated by the Ministry of Health, then it does not need to have further validation test.
The test samples used for validation tests are directly submitted to the Directorate of Medical Device Supervision, Ministry of Health.
RDT-Ag which not fulfill the above criteria will need to do a validation test:
- RDT-Ag swab kit will be tested by two different laboratories.
- If there is a discordant result, it will be determined by the National Institute of Health Research and Development using the gold standard.
- The standard operational test procedure includes 30 samples with CT ≤ 25, 30 samples with CT> 25, and 30 samples negative.
- Each laboratory receives 100 RDT-Ag kits
- Testing time is 1 week from the sample kit RDT-Ag received by the laboratories.
- Testing sample must be taken 24-48 hours (nasal swab test)
7 test facilities recognized by the Ministry of Health are as follow: Faculty of Medicine-University of Indonesia, Faculty of Medicine, Public Health, and Nursing-Universitas Gadjah Mada, Faculty of Medicine-Airlangga University, Faculty of Medicine-Andalas University, Faculty of Medicine-Padjajaran University, Center for Health Laboratory (BBLK) Jakarta and Center for Environmental Health Engineering and Disease Control (BBTKLPP) Jakarta.
Moreover, RDT-Ag products shall be evaluated by the National Institute of Health Research and Development of the Ministry of Health, or an independent agency designated by the Ministry of Health every 3 months.
On April 22, 2021, the Ministry of Health issued announcement No. FR.02.01 / 5/0469/2021 to require RDT Antigen to have local testing in 1 appointed laboratory prior to registering the products or doing certificate renewal. Therefore, RDT Antigen products will need to do a validation test 1 time before new registration or renewal, and 2 more validation test after approval. This policy will also apply to RDT-Ag products that have received WHO EUL, US FDA, and EMA recommendations.
Announcement No. FR.01.01 / 3 / 0139A / 2021 Regarding Registered Rapid Diagnostic Test of Antigen Covid-19
Decree of the minister of health number HK.01.07 / MENKES / 446/2021 Concerning Use of Rapid Diagnostic Antigen Test in Examination Corona Virus Diseases 2019 (COVID-19)