Ministry of Health Brunei Darussalam
COVID-19 RAPID TESTS KITS (ART)
AUTHORISED FOR USED IN BRUNEI DARUSSALAM.
Page 1 of 3
The listed Covid-19 antigen rapid test kits that are recommended and authorized for use are based on the evaluation done by Ministry of Health, Brunei Darussalam. The results of the evaluations are determined according to the clinical and analytical performance of the test kits (sensitivity and specificity claimed by the manufacturers), safety standards, quality and efficacy of the test kits.
Ministry of Health, through the Department of Laboratory Services will continue to update the list of authorized Covid-19 rapid test kits in order to ensure the supplied antigen rapid tests kits are meeting the required standards.
This list is updated as at 1 November 2021.
NO PRODUCT NAME MANUFACTURER DETECTION SAMPLE TYPE 1 Panbio COVID-19
RAPID Test Device
Abbott Rapid Diagnostic Jena
GmBH, Jena, Germany Antigen Nasopharyngeal
2
Panbio COVID-19
RAPID Test Device Abbott Rapid Diagnostic Jena
GmBH, Jena, Germany Antigen Nasal
3 Biocan Tellmefast Covid-19 Antigen Test
Biocan Diagnostics Inc,
Canada Antigen Saliva/Nasal
4
INNOVITA One Step Rapid Test (2019-nCoV Ag Test
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO. LTD, Qian’an, Hebei, China.
Antigen Anterior Nasal /Saliva/
Nasopharyngeal
5 QuickVue At-Home OTC COVID-19 Test
Quidel Corporation
San Diego, USA Antigen Nasal
6
Roche SARS-CoV-2 Antigen Self-Test Nasal
SD Biosensor (South Korea) Roche Diagnostic GmBH, Germany
Antigen Nasal
7 ARISTA COVID-19 Antigen Rapid Test
Arista Biotech Pte. Ltd.
Singapore Antigen Nasal
8
NEWGENE Bioengineering COVID-19 Antigen Detection Kit
New Gene (Hangzhou)
Bioengineering Co., Ltd. China Antigen Sputum/
Nasopharyngeal/Nasal
9
ALLTEST Covid-19 Antigen Test Oral Fluid Self-Testing
ALLTEST (Hangzhou) Biotech
Co. Ltd. China Antigen Saliva (Oral Fluid)
10 Medomics SARs-Cov2 Antigen Test Kit (LFIA)
Jiangsu Medomics Medical
Technology Co. Ltd. China Antigen Saliva (Oral Fluid)
Ministry of Health Brunei Darussalam
COVID-19 RAPID TESTS KITS (ART)
AUTHORISED FOR USED IN BRUNEI DARUSSALAM.
Page 2 of 3
NO PRODUCT NAME MANUFACTURER DETECTION SAMPLE TYPE 11
Orawell COVID-19 Ag Rapid Saliva test Device
Jiangsu Well Biotech Co. Ltd.
China Antigen Saliva (Oral Fluid)
12 Veri-Q COVID-19 Ag
Rapid Test MICo BioMed Co. Ltd. Korea Antigen Nasopharyngeal 13 Flowflex SARS-CoV-2
Antigen Rapid Test
ACON Biotech (Hangzhou) Co.
Ltd. China Antigen Nasal/Saliva
14
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Professional use)
Joysbio (Tianjian)
Biotechnology Co. Ltd. China Antigen Saliva/Nasal
15
Wikang Medical SARS- CoV-2 Antigen Detection Kit (Self- use)
Xiamen Jiqing, Biomedical
Technology Co. Ltd. China Antigen Saliva/Throat /Nasal
16
Beright COVID-19 Antigen Rapid Test (Self-use)
Hangzhou Alltest Biotech Co.
Ltd China Antigen Oral Fluid
17
SALIXIUM COVID-19 Rapid Antigen Test
RESZON Diagnostics International Sdn. Bhd., Malaysia
Antigen
Saliva and Nasal
18 Genrui SARS-CoV-2
Antigen Test Kit Genrui Biotech Inc., China Antigen
Nasal
19
SARS-CoV-2 Antigen Rapid Test Kits for Self-Testing
Beijing Lepu Medical
Technology Co., Ltd., China Antigen
Nasal
20 SARS-CoV Ag Rapid Test Kit
Jiangsu Bioperfectus
Technologies Co., Ltd., China Antigen
Nasal
21
SG Diagnostics COVID- 19 Antigen Rapid Test Kit
SG Diagnostic Pte. Ltd.,
Singapore Antigen Nasal/Throat
22 JusChek COVID-19 Antigen Rapid Test
Hangzhou AllTest Biotech Co.,
Ltd., China Antigen
Oral Fluid
23
Ninonasal NG-Test®
SARS-CoV-2 Antigen Test Kit (Nasal)
NG Biotech, France Antigen Nasal
24
LYHER Novel Coronavirus (COVID- 19) Antigen Test Kit
Hangzou Laihe Biotech Co Ltd Antigen
Saliva
Ministry of Health Brunei Darussalam
COVID-19 RAPID TESTS KITS (ART)
AUTHORISED FOR USED IN BRUNEI DARUSSALAM.
Page 3 of 3
NO PRODUCT NAME MANUFACTURER DETECTION SAMPLE TYPE 25 Clinitest Rapid Covid-
19 Antigen Test
Healgen Scientific Limited
Liability Company, USA Antigen Nasopharyngeal/
Nasal 26 INDICAID® COVID-19
Rapid Antigen Test
Phase Scientific International
Ltd., Hong Kong Antigen Nasal
27
Rapid ResponseTM COVID-19 Antigen Rapid Test Device
BTNX Inc., Canada Antigen Nasal /
Nasopharyngeal
28
HOTGEN Coronavirus (2019-nCoV)-Antigen Test
Beijing Hotgen Biotech Co.,
Ltd., China Antigen Nasal
29 HIGIA SARS-CoV-2 Antigen Rapid Test Kit
Xiamen Higia Medical
Technology Co., Ltd., China Antigen Saliva 30 iHealth Novel Corona
Virus (SARS-CoV-2)
Symbion Asia Sdn Bhd.
Malaysia Antigen saliva
