The HBsAg Rapid Test Cassette is a rapid test to qualitatively detect the presence of HBsAg in serum or plasma specimen. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBsAg in serum or plasma.
Allow test device, specimen, and/or controls to equilibrate to room temperature ( 15-30c ) prior to testing.
Remove the test device from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 drops of sample ( approx . 120L ) to the specimen well ( S ) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well ( S ). See the illustration below.
Wait for the red line ( s ) to appear. Depending on the concentration of HBSAG positive results may be observed in as short as 60 seconds. However , to confirm negative results. the complete reaction time, 30 minutes, is required.
Sensitivity
The LINEAR Hepatitis B Antigen ( HBsAg ) Cassette Test detects HBSAG concentration greater than 2 ng/ml ( including any subtypes ) in human serum by the development of a colored line in the test region of the test device.
Specificity
The LINEAR Hepatitis B Antigen ( HBsAg ) Cassette Test uses an antibody that is highly specific for Hepatitis B Antigen ( HBsAg ) in serum. A result of 99.5 % concordance to the ELISA test was determined by a clinical study of 1208 samples.
The Hepatitis B surface antigen (HBsAg) test is done to confirm the presence or absence of the Hepatitis virus in the blood. HBsAg is also known as Australian Antigen. The test is done to screen patients for Hepatitis B infection.
They should take further tests to determine if the Hepatitis B infection is acute or chronic. - The treatment for acute and chronic infection is different and hence, it is of utmost importance for the patient to determine the level of infection - Regular monitoring by a specialized physician or doctor is required.