For those who are looking for Covid-19 Self-Test kit, below is the list of all tests that have been selected to date and the status is Conditional Approval by MDA – Medical Device Authority Malaysia
SELF-TEST COVID-19 TEST KIT FOR CONDITIONAL APPROVAL (APPROVED)
The list of Self-Test Covid-19 Test Kit that is approved for Conditional Approval based on the decision on the consensus of the Covid-19 Test Kit Expert committee is as follows.All test submissions are scored according to: -
• the manufacturer reported clinical and analytical performance evidence.
• the evaluation test results from testing facilities are according to the committee evaluation criteria set by Clinical expert panels.
• Supporting Documents for COVID-19 IVD Test Kits Conditional Approval.
The use of COVID-19 self- test kit shall be limited for screening purpose only and all test results need further confirmation using RT-PCR.
This test kit can be supplied by registered pharmacists or private healthcare facilities.
| NO | COMPANY NAME | PRODUCT NAME | MANUFACTURER | IDENTIFIER | DETECTION | SAMPLE TYPE |
|---|---|---|---|---|---|---|
| 1 | Reszon Diagnostic International Sdn Bhd | Salixium-COVID-19 Rapid Antigen Rapid Test (Saliva/ Nasal Swab Samples) | Reszon Diagnostics International Sdn Bhd. selangor, Malaysia | SLXHB1-0621001 | RTK-Antigen (Self-test) | Saliva and nasal swab samples (Mix Samples) |
| 2 | Citymedic Sdn Bhd | Gmate® COVID-19 Ag Saliva for Home Use | Philosys Co., Ltd, Republic of Korea | AG-020 | RTK-Antigen (Self-test) | Saliva |
| 3 | Medinics (M) Sdn Bhd | BERIGHT-COVID-19 Antigen Rapid Test Device (Oral Fluid) | Hangzhou AllTest Biotech Co., Ltd. Zheijang, P.R. China | ICOV-802H | RTK-Antigen (Self-test) | Saliva |
| 4 | Global Science Sdn Bhd | ALLTest COVID-19 Antigen Rapid Test (Oral Fluid) | Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China. | ICOV-802H | RTK-Antigen (Self-test) | Saliva |
| 5 | Neopharma Biotech Asia Sdn Bhd | JusChek COVID-19 Antigen Rapid Test (Oral Fluid) | Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China. | ICOV-802H | RTK-Antigen (Self-test) | Saliva |
| 6 | Jingga Anggun Sdn Bhd | Longsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (Immunochromatography) Home based Use | Guangdong Longsee Biomedical Co. Ltd.,Guangzhou,P.R. China | LS-C-T-005 | RTK-Antigen (Self-test) | Saliva |
| 7 | Hexamine Sdn Bhd | Sichuan Xincheng SARS-CoV-2 Antigen Assay | Sichuan Xincheng Biological Co. Ltd., P.R. China. | T4001W | RTK-Antigen (Self-test) | Nasal swab |
| 8 | Translab (M) Sdn Bhd | Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-testing) | ACON Biotech (Hangzhou) Co., Ltd., P.R.China | L031-118M5 | RTK-Antigen (Self-test) | Nasal swab |
| 9 | Neoscience Sdn Bhd | STANDARD™ Q COVID-19 Ag Saliva Home Test | SD Biosensor, Inc. Republic of Korea | Ref No: Q-NCOV-02G Cat. No: 09COV131 | RTK-Antigen (Self-test) | Saliva |
| 10 | Medical Innovation Ventures Sdn Bhd | ProDetect™ COVID-19 Antigen Rapid Self-Test (Saliva) | Medical Innovation Ventures Sdn Bhd, Penang, Malaysia | PR-CVDCAgS | RTK-Antigen (Self-test) | Saliva |
| 11 | Dewina Consult Sdn Bhd | NEWGENE Bioengineering COVID-19 Antigen Detection Kit | New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China | COVID-19-NG08 | RTK-Antigen (Self-test) | Saliva or Nasal swab |
| 12 | Tree Med Sdn Bhd | Lituo COVID-19 Antigen Detection Kit (Colloidal Gold) Self Test Kit | Zhuhai Lituo Biotechnology Co., Ltd. P. R. China | LCV051 | RTK-Antigen (Self-test) | Saliva |
| 13 | Pahang Pharmacy Sdn Bhd | GRUENBANKA SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) | Ningbo Lvtang Biotechnology Co. Ltd., Zhejiang P.R, China. | JQ-nCovAg-S | RTK-Antigen (Self-test) | Saliva |
| 14 | Malaysian Diagnostics Corporation Sdn Bhd | Humasis COVID-19 Ag Home Test (Self-Test) | Humasis Co. Ltd., Republic of Korea. | ACOVAGS-7025 | RTK-Antigen (Self-test) | Nasal swab |
Updated 30 August 2021