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%
☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes
☀ Certified by Authoritative Certification System and Standards
☀ Reliable: Accuracy higher than 98%, early detection of the presence of HBsAg Antigen.
☀ Simple: No Instrument Required
☀ 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.
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.
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.
Plasma
☀ Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
☀ Separate the plasma by centrifugation.
☀ Carefully withdraw the plasma for testing, or label and store it at 4℃ for up to five days. Plasma may be frozen at -20℃ for at least three months.
Serum
☀ Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
☀ Allow the blood to clot.
☀ Separate the serum by centrifugation.
☀ Carefully withdraw the serum for testing or label and store it at 4℃for up to five days. Serum may be frozen at -20℃ for at least three months.
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.
The kits should be stored at temperature 4-30°C,( the sealed pouch) for the duration of the shelf life (24 months).