HBSAG Rapid Test Kit
Product Details:

Material	Plastic
Usage/Application	Hospital
Packaging Size	40 kits
Reference	IHBsg-402
Brand	ABON
Country of Origin	Made in India
Certificate	CE 1023

Introduction:-
HBsAg Rapid Test is a, direct binding test for the visual detection of hepatitis B surface antigen (HBsAg) in serum,
plasma or whole blood. It is used as an aid in the diagnosis of hepatitis B infection. The One Step HBsAg Whole Blood
The test is based on the principle of sandwich immunoassay for determination of HBsAg in serum or whole blood.
Monoclonal and polyclonal antibodies are employed to identify HBsAg specifically. This one-step test is very sensitive
and only takes 10 minutes. Test results can be read visually without any instrument.
Principle:-
This test strip contains a membrane strip, which is pre-coated with mouse monoclonal anti-HBs capture antibody on
the test band region. The mouse monoclonal anti-HBs-colloid gold conjugate and sample moves along the membrane
chromatographically to the test region (T) and forms a visible line as the antibody-antigen-antibody gold particle
complex forms. Both the Test Line and Control Line are not visible before applying any samples. The Control Line is
used for procedural control. The Control line should always appear if the test procedure is performed properly and the
reagents of the control line are working.
Materials Included and Active Ingredients:-
1) HBsAg kit contains the following items to perform the assay.
Ø HBsAg test device foil pouched with a desiccant
Ø Instruction for use
Kit Precautions and Storage Instructions:-
1) For best results, adhere to instructions provided
2) All specimens should be handled as potentially infectious
3) The test device should be stored at room temperature
4) The test device is sensitive to humidity as well as heat
5) Do not use beyond the expiration date
6) Do not use test kit if the pouch is damaged or seal is broken
7) Use test device immediately after removing from the pouch
8) The components (test device and assay diluents) in this kit have been quality control tested as a standard
batch unit. Do not mix components from different lot numbers.
9) Store kit at room temperature (2 -30 oC). Do not expose the kit to temperature over 30 oC
Warnings:-
1) For in vitro diagnostic use only. DO NOT RE-USE test device
2) The instructions must be followed to obtain accurate results. Anyone performing an assay with this product
must be trained in its use and laboratory procedures.
3) Do not eat or smoke while handling specimens
4) Wear protective gloves while handling specimens. Wash hands thoroughly afterward.
5) Avoid splashing or aerosol formation
6) Clean up spills thoroughly using an appropriate disinfectant
7) Decontaminate and dispose of all specimens, reaction kits, and potentially contaminated materials, as if
they were an infectious waste, in a biohazard container.
8) Do not mix with other specimens.