PRODUCT DETAILS

1. PRODUCT NAME: GenFarm SARS-CoV-2 Antigen Detection Kit

2. SAMPLE TYPE: Nasal swab & Saliva sample method (2 in 1)

3. MANUFACTURER: Ningbo Lvtang Biotechnology Co., Ltd. P.R.China

4. IDENTIFIER: CovAg-NS

5. LOT NUMBER: 2023101

6. MANUFACTURED IN: China

7. MDA APPROVAL NO: 88

8. STORAGE CONDITIONS & VALIDITY: Store at 2C – 30C and it is valid

for 24 Months.

9. SPECIFICATION:
Packaging: 1 kit (1 individual box), 1 Box (25 individual kits), 1 Carton (25
Box/500 Kits).
Dimensions: 51.5 X 36 X 54.5 CM (Gross Weight: 16.2 KG) (Nett
Weight:20.2KG)

10.APPROVED IN 12 COUNTRIES: (Malaysia, Japan, Britain, Italy, Brazil,

Germany, Czech Republic, Austria, Netherlands, Finland, Spain, and Chile)

11.COMPONENTS: Nasal Swab, Extraction Buffer Tube, Dropper (inside test

card sealed aluminium foil bag), Saliva Collection bag, Biohazard specimen
bag, Test card, Instruction Manual (English and Bahasa Malaysia)

12.Accuracy based on IMR Malaysia: Nasal: 90% Sensitivity and 100%

Specificity, Saliva: 96.7% Sensitivity and 100% Specificity.
Product Introduction

Copyright 2021 LvtangBio All Rights Reserved.

Product Introduction

Copyright 2021 LvtangBio All Rights Reserved.

Testing Procedure --Nasal Swab

Copyright 2021 LvtangBio All Rights Reserved.

Testing Procedure--Saliva

Copyright 2021 LvtangBio All Rights Reserved.

Certification

Ningbo Lvtang Biotechnology Co., Ltd. has a clean workshop that meets the GMP production
standard of medical devices, has passed the ISO13485 system certification of British BSI, and
has complete laboratory and production conditions. Relevant in vitro diagnostic reagent products
have been registered by the British drug administration (MHRA), obtained EU CE certification,
and have been listed in the “white list" of epidemic prevention materials exported by the
Ministry of Commerce.

Copyright 2021 LvtangBio All Rights Reserved.

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For in vitro diagnostic and self-testing used only.Do not use after expiration date.

WEB: www.lvtangbio.com
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Hanya untuk in vitro kegunaan diagnostik dan ujian sendiri sahaja, Jangan guna selepas tarikh luput

WEB: www.lvtangbio.com
TECHNICAL REPORT

IVD Test Assay Evaluation of Genfarm

SARS-CoV-2 Antigen Detection Kit
Prepared by:

JURAINA ABD JAMIL

Research Officer
WHO Collaborating Centre for Arbovirus Reference & Research (WHOCC: MAA-12)
Tropical Infectious Diseases Research & Education Centre (TIDREC)
Universiti Malaya

DR. TEOH BOON TEONG

Technical Manager
WHO Collaborating Centre for Arbovirus Reference & Research (WHOCC: MAA-12)
Tropical Infectious Diseases Research & Education Centre (TIDREC)
Universiti Malaya

Approved by:

PROFESSOR DR. SAZALY ABU BAKAR

Director
WHO Collaborating Centre for Arbovirus Reference & Research (WHOCC: MAA-12)
Tropical Infectious Diseases Research & Education Centre (TIDREC)
Universiti Malaya
 Material Tested:

Genfarm SARS-CoV-2 Antigen Detection Kit

Manufactured by:

NINGBO LVTANG BIOTECHNOLOGY CO. LTD.

Distributed by: