Transcription of Ministry of Health Brunei Darussalam COVID-19 RAPID TESTS ...
1 Ministry of Health Brunei Darussalam COVID-19 RAPID TESTS KITS (ART) AUTHORISED FOR USED IN Brunei Darussalam . Page 1 of 4 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 25 January 2022. 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.
2 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) / Nasal 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 4 NO PRODUCT NAME MANUFACTURER DETECTION SAMPLE TYPE 11 Orawell COVID-19 Ag RAPID Saliva test Device Jiangsu Well Biotech Co.
3 Ltd. China Antigen Saliva ( oral Fluid) 12 Veri-Q COVID-19 Ag RAPID Test MiCo BioMed Co. Ltd. Korea Antigen nasopharyngeal / Nasal 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 (Tianjin) 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.
4 , Ltd., China Antigen Nasal 21 SG Diagnostics COVID-19 Antigen RAPID Test 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 NG Biotech, France Antigen Nasal 24 LYHER Novel Coronavirus ( COVID-19 ) Antigen Test Kit Hangzhou 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 4 NO PRODUCT NAME MANUFACTURER DETECTION SAMPLE TYPE 25 CLINITEST RAPID COVID-19 Antigen Test Healgen Scientific Limited Liability Company, USA Antigen Nasal / nasopharyngeal 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.
5 , Ltd., China Antigen Nasal 29 HIGIA SARS-CoV-2 Antigen RAPID Test Kit Xiamen Higia Medical Technology Co., Ltd., China Antigen Nasal / Saliva 30 iHealth Novel Corona Virus (SARS-CoV-2) Symbion Asia Sdn Bhd. Malaysia Antigen Saliva 31 Fastep COVID-19 Antigen RAPID Test Assure Tech (Hangzhou) Co., Ltd., China Antigen nasopharyngeal / Oropharyngeal 32 StrongStep SARS-CoV-2 RAPID Antigen Test Nanjing Liming Bio-product Co., Ltd, China Antigen Nasal / Oropharyngeal 33 Gensure COVID-19 Antigen RAPID Test Kit Gensure Biotech Inc., China Antigen Nasal / Saliva 34 Lituo COVID-19 Antigen Self-Test Kit Zhuhai Lituo Biotechnology Co. Ltd., China Antigen Saliva 35 BIO-RAD Coronavirus Ag RAPID Test Zhejiang Orient Gene Biotech Co., Ltd., China Antigen nasopharyngeal / Nasal 36 Cas- Envision SARS-CoV-2 Antigen RAPID Detection Kit Shenzhen CAS-Envision Medical Technology Co. Ltd., China Antigen Nasal / Saliva 37 Vstrip COVID-19 Antigen Test PANION & BF Biotech Inc.
6 , Xizhi Factory, Taiwan Antigen Nasal / nasopharyngeal 38 TESTSEALAB COVID-19 Antigen Test Hangzhou TestSea Biotechnology Co. Ltd., China Antigen Nasal 39 Babio SARS-CoV-2 Antigen RAPID Detection Kit Jinan Babio Biotechnology Co., Ltd., China Antigen Nasal / Saliva 40 Longsee 2019-nCoV Ag RAPID Detection Kit Guangdong Longsee Biomedical Co., Ltd., China Antigen Saliva Ministry of Health Brunei Darussalam COVID-19 RAPID TESTS KITS (ART) AUTHORISED FOR USED IN Brunei Darussalam . Page 4 of 4 NO PRODUCT NAME MANUFACTURER DETECTION SAMPLE TYPE 41 Norman Novel Coronavirus Antigen Testing Kit Nanjing Norman Biological Technology Co., Ltd., China Antigen Nasal / Saliva 42 Lysun COVID-19 Antigen RAPID Test Device Hangzhou Lysun Biotechnology Co., Ltd., China Antigen Nasal 43 INVBIO Coronavirus (SARS-CoV-2) Antigen RAPID Test Cassette Innovation Biotech (Beijing) Co., Ltd., China Antigen Nasal 44 AndLucky COVID-19 Antigen RAPID Test Zhejiang Anji Saianfu Biotech Co.
7 , Ltd., China Antigen Nasal / nasopharyngeal / Oropharyngeal 45 eDiagnosis COVID-19 (SARS-CoV-2) Antigen Test Kit Wuhan EasyDiagnosis Biomedicine Co., Ltd., China Antigen Nasal / nasopharyngeal / Oropharyngeal 46 ENCODE SARS-COV-2 Antigen RAPID Test Device Zhuhai Encode Medical Engineering Co., Ltd., China Antigen Nasal / Oropharyngeal 47 Multi G COVID-19 Check-Sal Antigen RAPID Test Multi-G bvba, Belgium Antigen Saliva 48 Global Select COVID-19 Antigen RAPID Test Zhejiang Jilong Biotechnology Co., Ltd., China Antigen Saliva 49 ZhongShan COVID-19 RAPID Antigen Test ZhongShan Biotech Co. Ltd., China Antigen nasopharyngeal / Oropharyngeal
