Complaint
INTENDED USE
The Hepatitis B Virus (HBV) Combo Test (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb in serum or plasma.
INTRODUCTION
Chronic hepatitis B is a serious, debilitating illness that can cause cirrhosis of the liver, liver cancer and death. Chronic hepatitis B is the main cause of liver cancer and the tenth leading cause of death worldwide, with 400,000,000 people infected with the virus. Every year, one million people worldwide are expected to die from this infection.
Most people fight off the infection themselves, but approximately 5-10 percent of those infected with the virus become carriers, and an additional 5-10 percent of those infected each year will progress to chronic liver disease, cirrhosis and possibly liver cancer.
| 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.
