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
1. High Sensitivity: > 96%
2. Specificity: 100%
3. Reliable: Accuracy higher than 98%, early detection of the presence
of HBsAg Antigen.
4. Simple: No Instrument Required
5. Convenient: Room Temperature Storage Built-In Control
6. Fast: Results in 5-30 minutes, strong positive results may be
observed promptly within 3 minutes
7. Certified by Authoritative Certification System and Standards
8. 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
1. One sealed pouched cassette with desiccant and a disposable
pipette..
2. Blood diluent in a dropper bottle. Store at 2-8℃
3. One piece of operating instruction with 40 test pouches.
Sample Collection and Preparation
Whole Blood ( Fingerstick Specimens)
Clean the area to be lanced with an alcohol swab.
Squeeze the end of the fingertip and pierce it with a sterile
lancet ; Wipe away the first drop of blood with sterile gauze or cotton; Use micropipette to obtain about 100ul fresh blood.
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.
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.
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).
