产品信息 - one step Hbsag Rapid Test->biological technology

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Jiaxing U-Life Medical Device Technology company

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one step Hbsag Rapid Test

产品分类 :

生化科技->生化->生物科技

产品规格

Country	CN
Brand	U-life

产品描述

INTENDED USE
The HBsAg Rapid Test is a Chromatographic immunoassay (CIA) for direct qualitative detection of Hepatitis B type virus surface antigen (HBsAg) in human serum /plasma and whole blood.

PRINCIPLE
The HBsAg RST is a chromatographic immunoassay (CIA) for the detection of surface antigens of Hepatitis B in human serum/plasma and whole blood. Specific antibody against HBsAg is pre-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with other specific antibodies. If HBsAg present, a pink colored band will develop on the membrane in proportion to the amount of HBsAg presented in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of HBsAg.

STORAGE
The kits should be stored at temperature 4-30° C, the sealed pouch for the duration of the shelf life (24 months)

PROCEDURE
Serum or Plasma Sample
Add 70-100UL or 2-3 drops of serum or plasma into sample well. Observe the result in 5-20 minutes.

Whole Blood Sample
Add 1 drop of whole blood into sample well, after all blood completely absorbed. Add 1 drop of whole blood diluent. Observe the result in 5-20 minutes.

INTERPRETATION OF RESULTS
Negative: No band in the test region (T), only one pink band appears in the control region (C). This indicates that no HBsAg have been detected.

Positive: In addition to the band in the control region (C), another pink band will appear in the test region (T). This indicates that the specimen contains HBsAg.

Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

High sensitivity, high specificity and highly reliable

Format: Strip, cassette

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