Hepatitis B Surface Antigen (HBsAg) Infectious Disease Rapid Test

• Type: IVD Reagent
• Test Parameter: Hbsag
• Result Time: 15 Mins
• Accuracy: 98.5%
• Shelf Life: 24 Months
• Transport Package: Cartons
• Model NO.: BSAG-DW02
• Specification: 25 tests/box, 40tests/box
• Trademark: Dewei
• Origin: China
• HS Code: 3822190090
• Production Capacity: 100, 000 Tests/Day

Product Description

Product Description

INTENDED USE

The HBsAg Test (Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of HBsAg in human serum or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HBV infection.

 

INTRODUCTION

Hepatitis B virus (HBV) is the prototypic member of the hepadnaviruses. Hepatitis B surface antigen (HBsAg) is located in the lipid envelope of this small DNA virus. During the replicative phase of the virus, this surface antigen is produced in excess and is detectable in the blood of the infected. The incubation period of HBV is 6 weeks to 6 months.
 

Manufacturer	Dewei Medical Equipment Co., Ltd
Product Categories	IVD Test
Principle	Rapid Colloidal Gold Immunochromatography
Detection	Qualitative
Storage	2~30 º C
Component	Rapid Test
Package	25T/box, 50T/Box, 100T/Box
Trademark	Dewei
Origin	China

MAIN CONTENTS

Test Cassette

Droppers

Buffer

Instructions for use

 

STORAGE AND STABILITY

Store at 2 ~ 30 º C in the sealed pouch for 24 months.

Keep away from direct sunlight, moisture and heat.

Do not freeze.

TEST PROCEDURE
1. Remove the test from its sealed pouch, and place it on a clean, level surface. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 3 drops of the specimen (approximately 75 µL) to each specimen well (S) of the device, then add one drop of buffer and start the timer.
3. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

Detailed Photos

 

 

Company Profile

About Us
 

DEWEI Medical Equipment Co., Ltd is a leading and professional manufacturer of IVD products, it is a high-tech enterprise specialized in developing, manufacturing and marketing IVD products.
DEWEI products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research centers, and college laboratories. Quality is the primary concern, DEWEI team is strict on quality control systems thus our products have CE, ISO, CFDA, and other international standards certificates.
The view of DEWEI is to be the most professional and respected enterprise in the IVD field, DEWEI will go on to provide the best service to you with outstanding R&D and cost-effective products.
 

R&D Team
 

15% of annual sales amount is devoted R&D department. With a professional R&D team, Dewei is continuously making new achievements in innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.

Certificate
 

Production Workshop
 

Transportation

 

Exhibition