Hepatitis B Surface Antigen(HBsAg) Rapid Test Manual
【PRODUCT INTRODUCTION】
The HBsAg Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of HBsAg in human whole blood, serum or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HBV infection.
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.
【FEAUTURES】
Simple; Accurate; Fast
| Product Name |
HBsAg Rapid Test |
| Brand |
Dewei |
| Format |
Strip/Cassette |
| Usage |
Professional IVD use only |
| Catagory |
Infectious Diseases |
| Manufacturer |
Dewei Medical Equipment Co., LTD |
【METHOD】
The HBsAg Test (Whole blood/Serum/Plasma) detects HBsAg through visual interpretation of color development on the internal strip. Anti-HBsAg antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-HBsAg antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there is enough HBsAg in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
【CONTENTS】
• Rapid test cassette with desiccant. • Disposable pipettes • Buffer • Package insert
【DIRECTION OF USE】
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 serum or plasma specimen to the specimen well (S) of the device and start the timer.
OR
Transfer 1 drop of whole blood specimen to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer 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.
4. Results reading.
【STORAGE AND STABILITY】
The kit should be stored at 2-30°C.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
【Manufacturer】
DEWEI MEDICAL EQUIPMENT CO.,LTD
5th floor, No. 4 building, Shiyou Industrial Park, Jun'an , Shunde, Foshan, China 528329
For further operation or performance details, please refer to final intruction manual.
Your message must be between 20-3,000 characters!