SELF-TEST COVID-19 TEST KIT FOR CONDITIONAL APPROVAL (APPROVED)

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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.

Below is the list of all tests that have been selected to date and the status is Conditional Approval (please note: list is updated on a routine basis).

Notes:
*Sample type is based on testing facility evaluation report.

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, 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.

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, China LS-C-T-005 RTK-Antigen (Self-test) Saliva

Updated 29 July 2021

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