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