PROSTATE SPECIFIC ANTIGEN (PSA) rapid test

For the semi-qualitative assessment of human PSA in human whole blood, serum or plasma

INTENDED USE:

Rapid PSA Test is an immunochromatography based one step in vitro test. It is designed for the rapid semi-quantitative determination of human prostate specific antigen (PSA) in serum or plasma specimens.

SPECIFICATION:

1)        Specimen: whole blood/serum/plasma

2)        Format: strip/cassette

3)        Sensitivity: 98.3%

4)        Specificity: 100%

FEATURE:

1)        Simple: simply add specimen and dilution(if necessary) into sample well

2)        Rapid: results come out at 5-10 minutes

3)        Visually interpreted: don’t need any equipment

4)        Stable: more than 12 month period of validity

PACKING:

1)        Strip: 100 tests/box

2)        Cassette: 25 tests/box, 50 tests/box

PROCEDURE:

1)        Bring all materials and specimens to room temperature.

2)        Remove the test card from the sealed foil pouch.

3)        Place the transfer pipette in the specimen and depress the bulb to withdraw a sample.

4)        Hold the pipette in a vertical position over the sample well of the test card and deliver 3 drops(120-150 ml) of sample into the sample well.

5)        Read the result at 5 – 10 minutes.

PRINCIPLE:

Rapid PSA test is a sandwich immunoassay. When serum sample is added to sample pad, it moves through the conjugate pad and mobilizes gold anti-PSA conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with anti-PSA antibody that is coated on the test region. If PSA is present, the result is the formation of a colored band in the test region.  The color intensity is dependent on the concentration of PSA in the sample. On the other hand, a light color band will always appear at the control zone. This control band serves as a reference of 4.0 ng/ml of PSA.