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).