Hepatitis B Surface Antibody (HBsAb) Serum Plasma Sample Rapid Test

• Customization: Available
• Type: IVD Reagent
• Certificate: ISO, CE
• Model NO.: BSAB-DP02
• Shelf Life: 24 Months
• Usage: Professional Use
• Sample: Serum Plasma
• Result Time: Within 15 Mins
• Principle: Immunochromatography
• Storage: 2~30ºC
• Transport Package: Cartons
• Specification: 40test/box
• Trademark: Dewei
• Origin: China
• Production Capacity: 100, 000PCS/Day

Product Description

 

Intended Use

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

Introduction

Hepatitis B virus (HBV) is the most thoroughly characterized and complex hepatitis virus. The infective particle consists of a viral core plus an outer surface coat. HBV has at least 3 distinct antigen-antibody systems that can be tested: HBsAg, HBcAg, and HBeAg. HBV surface coat can be detected in serum as HBsAg. HBsAg characteristically appears during the incubation period, usually 1 to 6 weeks before clinical or biochemical illness develops, and implies infectivity of the blood. The corresponding protective antibody (anti-HBs or HBsAb) appears weeks or months later, after clinical recovery, and usually persists for life; thus, its detection indicates past HBV infection and relative immunity. Unfortunately, in 5 to 10% of patients, HBsAg persists and antibodies do not develop; these patients become asymptomatic carriers of the virus or develop chronic hepatitis. Since this antibody is recognized as the marker of immunity to HBV, the World Health Organization (WHO) includes a HBsAg diagnostic procurement program for the control of Hepatitis B. Many people, especially newborn infants, receive vaccination. The minimum standard titer of HBsAb for protective immunity to HBV is 10 mIU/mL.

Contents

• Rapid test cassette with desiccant. 
• Disposable pipettes.
• Package insert

Storage & Statibility

• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE

Sample Collection

• The HBsAb Test is intended for use with human serum or plasma specimens only.
• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
• Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
 

Operation

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 2 drops of specimen to the specimen well (S) of the device and start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane.
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.

 

Detailed Photos

 

Company Profile

About Us

Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
During the special period of Corona, Dewei also develop the reagent kits, like Virus Transport Medium with swab, Rapid test and Saliva Collection Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
 

R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on 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.

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