One Step HBsAg Rapid Test Kit (Cassette)

Intended use

The One Step HBsAg Test is a rapid chromatographic immunoassay for the qualitative detection ofHepatitis B surface Antigen (HBsAg) in Whole Blood /Serum / Plasma. 

Test principle

The One Step HBsAg Test is a qualitative membrane strip based immunoassay for the detection ofHepatitis B surface Antigen in Whole Blood /Serum / Plasma. In this test procedure,HBsAg antibody is immobilized in the test line region of thedevice. After a Whole Blood /Serum / Plasma specimen is placed in the specimen well, it reacts

with HBsAg antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilizedHBsAg antibody. If the specimen containsHepatitis B surface Antigen, a colored line will appear in the test line region indicating a positive result. If the specimen does not containHepatitis B surface Antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. 

Materials and Components

1.Test devices 

2.Disposable specimen droppers  

3.Buffer(for whole blood only) 

4.Package insert 

Product Information

Test Procedure

Allow the test, specimen,buffer and/or controls to reach room temperature 15-30℃(59-86℉) prior to testing.

1.Testing

Place the test device on a clean and level surface.

(1) For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen well(S) of the test device, then start the timer. 

(2) For whole blood specimens: Hold the dropper vertically and transfer 1 drop of whole blood(approximately 35μl) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 70μl) and start the timer.

2.Test Results