COMPONENTS

The HBsAb One Step Hepatitis B Surface Antibody Test Device (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Antibody to Hepatitis B Surface Antigen in serum or plasma

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MATERIALS

Materials Provided

·Test devices

·Package insert

Materials Required But Not Provided

·Specimen collection container

·Centrifuge (for plasma only)

·Timer

DIRECTIONS FOR USE

Allow test device, serum or plasma specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1.Bring the pouch to room temperature before opening it. 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.

2.Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of serum or plasma (approx. 75l) 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.

3.Wait for the red line(s) to appear. The result should be read at 15 minutes. It is important that the background is clear before the result is read.

Note: A low HBsAb concentration might result in a weak line appearing in the test region (T) after an extended period of time; therefore, do not interpret the result after 20 minutes.

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