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Medical device of Diagnostic test kit HBV test
1. Principle:
One Step HBV test is a rapid immunochromatographic assay designed for qualitative determination of hepatitis B Virus(HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) in human serum or plasma. In these five substance, the HBsAg & HBeAb & HBeAg adopt sandwich method, while HBeAb & HBcAb adopt competitive assay.
2. Characteristic:
High sensitivity and specificity, result in 15 minutes.
Detection of HBsAg, HBsAb, HBeAg, HBeAb, HBcAb
Simple to use, without any additional instruments.
Store in room temperature
24 months shelf life
Easy to carry and suitable for professional use
3. Sensitivity and Specificity
| 320 Samples | Positive | Negative | ||||
| Positive | False positive | Total | Negative | False negative | Total | |
| HBsAg(200+) | 200 | 2 | 202 | 118 | 0 | 118 |
| Anti-HBs(120+) | 125 | 2 | 127 | 192 | 1 | 193 |
| HBeAg(65+) | 71 | 1 | 72 | 247 | 1 | 248 |
| Anti-HBe(55+) | 61 | 1 | 62 | 257 | 1 | 258 |
| Anti-HBc(120+) | 124 | 2 | 126 | 191 | 3 | 194 |
The results show that the coincidence with clinical diagnostic of HBV test is similar to ELISA method. Our one step HBV test has high sensitivity of more than 98.3% and high specificity of more than 98.1%. The reagent's manipulation is quite easy and its results easy to interpret. It also showed no side-effect and contraindication. So it is suitable as an aid in the HBV diagnosis, monitoring and prediction of the outcome. The reagent deserves popularizing.
4. The Test is available in strip and cassette format
| Product name | Format | Width | Specimen | Sensitivity |
| HBsAg Hepatitis B Surface Antigen Test | Strip | 2.5mm | Serum/Plasma Whole blood | 1ng/mL |
| 3.5mm | ||||
| 5.0mm | ||||
| Cassette | 4.0mm | |||
| HBsAb Hepatitis B Surface Antibody Test | Strip | 2.5mm | Serum/Plasma Whole blood | 10mIU/mL |
| 3.5mm | ||||
| 5.0mm | ||||
| Cassette | 4.0mm | |||
| HBeAb Hepatitis B Envelope Antibody Test | Cassette | 4.0mm | Serum/Plasma | Custom |
| HBeAg Hepatitis B Envelope Antigen Test | Cassette | 4.0mm | Serum/Plasma | Custom |
| HBcAb Hepatitis B Core Antibody Test | Cassette | 4.0mm | Serum/Plasma | Custom |
5. Procedure & Interpretation:
Our factory advantage:
1. Custom manufacturing of quality medical products and biochemical reagents.
2. Obtained ISO 9001 certificate,GMP approval,FDA approval and CE Mark already.
3. More than 30% of the employed staff have obtained master and doctor degree from prestigious worldwide institutions.
4. More than 30,000 square feet of laboratory space.
5. Immunogold Labeling Techniques.
6. Superb quality products with very affordable prices.
7. Provide prompt and effective after-sale service, ensure the customer no any risk on our products.
Our factory:
Medical device of Diagnostic test kit HBV test