Indonesia: Further validation for approved COVID-19 rapid diagnostic tests

ARQon
Jul 8, 2021
1 min read

The Indonesia Ministry of Health released an announcement (No. FR.01.01/3/0139A/2021) on 15 February 2021. The imported Rapid Diagnostic Test of Antigen (RDT-Ag) is eligible to apply further validation test must fulfil recommendations from:

WHO Emergency Used Listing (EUL)
US-FDA Emergency Used Authorization (EUA)
European Medicine Agency (EMA)

RDT-Ag that does not fulfill the above criteria will need to do validation test. The Standard Operational Procedures are as follows:

One RDT-Ag swab kit to be tested in two different laboratories.
If discordant result is found, it will be determined using a gold standard by National Institute of Health Research and Development.
Standard operational test procedure uses 30 samples with CT ≤ 25, 30 samples with CT> 25, and 30 samples negative.
100 RDT-Ag kits will be sent to each laboratory.
1 week of testing time given to the laboratory to test the sample kit RDT-Ag.
Nasal swab test sample must be taken in 24-48 hours.

The 7 test facilities that will be recognized by the Ministry of Health are as follows:

Faculty of Medicine-University of Indonesia
Faculty of Medicine, Public Health and Nursing University Gadjah Mada (UGM)
Airlangga University Medical Faculty Laboratory (UNAIR)
Andalas University Faculty of Medicine (UNAND) Laboratory
Padjadjaran University (UNPAD) Faculty of Medicine Laboratory
Center for Health Laboratory (BBLK) Jakarta
Center for Environmental Health Engineering and Disease Control (BBTKLPP) Jakarta