HBsAg (Hepatitis B Surface Antigen) Diagnostic Kit (Colloidal Gold)

For The Qualitative Detection of Hepatitis B Surface Antigen In Serum/Plasma and Whole Blood

Main Features

☀ High Sensitivity: > 96%
☀ Specificity: 100%
☀ Reliable: Accuracy higher than 98%, early detection of the presence of HBsAg Antigen.
☀ Simple: No Instrument Required
☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes
☀ Certified by Authoritative Certification System and Standards
☀ Convenient: Room Temperature Storage Built-In Control
☀ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"



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 RDT 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 anotherr specific antibody.

If HBsAg is 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 or absence of HBsAg.

Reagents and Materials Provided

☀ One sealed pouched cassette with desiccant and a disposable pipette..
☀ Blood diluent in a dropper bottle. Store at 2-8℃
☀ One piece of operating instruction with 40 test pouches.



Assay Procedure

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

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





Storage

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

Warning and Precautions

☀ FOR IN VITRO DIAGNOSTIC USES ONLY
☀ All patient samples should be treated as if capable of transmitting diseases.
☀ Do not interchange reagents from different lots or use test kit beyond expiration date.
☀ Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.