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Professional HBsAg Rapid Test Strip For In Vitro Diagnostic Use

Shenzhen Kisshealth Biotechnology Co., Ltd
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Professional HBsAg Rapid Test Strip For In Vitro Diagnostic Use

Brand Name : KISSH

Place of Origin : China

MOQ : 1000 tests

Price : Negotiable

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%

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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.


Product Tags:

In Vitro HBsAg Rapid Test Strip

      

HBsAg Rapid Test Strip

      

HBsAg Infectious Disease Test Kit

      
China Professional HBsAg Rapid Test Strip For In Vitro Diagnostic Use wholesale

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