Newscen Biopharm Co., Limited
Professional Manufacturer of Rapid Test Devices
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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
* Convenient: Room Temperature Storage Built-In Control
* Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes
* Certified by Authoritative Certification System and Standards
* Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"
Intended Use
Hepatitis B Surface Antigen Rapid diagnostic Test (HBsAg) is a lateral flow immunoassay for the simultaneous detection and differentiation of Hepatitis B Surface Antigen in human serum, plasma, or whole blood. The One-Step HbsAg Test is an easy and effective aid for the screening and diagnosis of Hepatitis B infection.
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.
Interpretation Of Results
Negative:
No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no HBsAg antibody has been detected.
Positive:
In addition to a pink-colored band in the control region (C), a pink-colored 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.
Storage
Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).