Shenzhen Kisshealth Biotechnology Co., Ltd
| Payment Terms | T/T |
| Supply Ability | 100,000 tests one day |
| Delivery Time | 5-8 work days |
| Packaging Details | 50 test strips/ box |
| Keywords | HBsAg Rapid Test Strip |
| Brand | KISSH |
| Storage Temperature | 15-30℃ |
| Shelf-life | 24 months |
| Sample Type | human serum or plasma |
| Accuracy | 99.5% |
| Brand Name | KISSH |
| Place of Origin | China |
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Product Specification
| Payment Terms | T/T | Supply Ability | 100,000 tests one day |
| Delivery Time | 5-8 work days | Packaging Details | 50 test strips/ box |
| Keywords | HBsAg Rapid Test Strip | Brand | KISSH |
| Storage Temperature | 15-30℃ | Shelf-life | 24 months |
| Sample Type | human serum or plasma | Accuracy | 99.5% |
| Brand Name | KISSH | Place of Origin | China |
| High Light | In Vitro HBsAg Rapid Test Strip ，HBsAg Rapid Test Strip ，HBsAg Infectious Disease Test Kit | ||
HBsAg Rapid Test Strip
INTENDED USE
HBsAg Rapid Test is a lateral flow immunochromatographic assay for the qualitative determination of Hepatitis B surface antigen (HBsAg) in human serum or plasma. It is intended for the screening of blood and blood products to be used for transfusion and an aid for the diagnosis of existing or previous hepatitis B infection. The test is recommended for professional use only. All results must be interpreted together with other clinical information or other diagnosis methods available to the physician.
PERFORMANCE
Sensitivity
HBsAg Rapid Test has been tested with a sensitivity panel ranging from 0 to 300ng/mL. All 10 HBsAg subtypes produced positive results on HBsAg Rapid Test. The test can detect 5 ng/ml of HBsAg in 10 minutes, and 1 ng/ml of HBsAg in 20 minutes.
Specificity:
Antibodies used for HBsAg Rapid Test were developed against whole Hepatitis B antigen isolated from Hepatitis B virus. Specificity of HBsAg Rapid Test was also tested with laboratory strains of Hepatitis A and Hepatitis C. They all yielded negative results.
HBsAg Rapid Test Strip vs. EIA test
| Relative Evaluation Results | EIA | Total | ||
| Positive | Negative | |||
| HBsAg Rapid Test | Positive | 345 | 5 | 350 |
| Negative | 2 | 980 | 982 | |
| Total | 347 | 985 | 1332 | |
The test results for HBsAg Rapid Test are as below:
Relative Sensitivity: 99.4%
Relative Specificity: 99.5%
Accuracy: 99.5%
Accuracy
Intra-assay:
Within-run precision was determined using 10 replicates of three specimens containing 0, 1 and 5 ng/ml of HBsAg. The negative and positive values were correctly identified in 100% of cases.
Inter-assay:
Between-run precision was determined using the same three specimens of 0, 1 and 5 ng/ml of HBsAg in 10 independent assays and with three different batches of HBsAg rapid test over a 6 month period. Again, the negative and positive values were correct in 100% of cases.
Company Details
Business Type:
Manufacturer
Year Established:
2018
Total Annual:
10,000,000-30,000,000
Employee Number:
50~150
Ecer Certification：
Active Member
Shenzhen Kisshealh Biotechnology Co., Ltd., located in the Pingshan District, Shenzhen, P.R. China. is a diagnostics company focused on the development and manufacture of IVD tests at the Point-of-Care with highly innovative proprietary technology. We focused on the emerging markets of ... Shenzhen Kisshealh Biotechnology Co., Ltd., located in the Pingshan District, Shenzhen, P.R. China. is a diagnostics company focused on the development and manufacture of IVD tests at the Point-of-Care with highly innovative proprietary technology. We focused on the emerging markets of ...
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