PSA Rapid Test

Product information

The PSA test is a rapid qualitative assay for the detection of Human PSA (free form or complexed with the α-1-antichymotrypsin) in plasma, serum or whole blood.

Advantages of PSA test

• Easy to perform
• No complex sample collection needed
• Accurate test result

General information

Prostate-specific antigen (PSA) is an intracellular glycoprotein (M.W. 34000 Dalton) synthesized only by the prostate gland and in seminal plasma. PSA, a normal constituent of prostate tissue, is present in benign hyperplastic and malignant prostatic tissue, in metastatic prostatic carcinoma, and in prostatic fluid and seminal plasma. PSA is elevated in serum of prostate cancer patients due to the release of the antigen into the circulation.

The PSA-Rapid Test is a rapid qualitative assay for the detection of Human PSA (free form or complexed with the α-1-antichymotrypsin) in plasma, serum or whole blood.
The method employs an unique combination of monoclonal-dye conjugate and monoclonal (mouse) solid phase antibodies to selectively identify PSA in the test samples with a high degree of sensitivity.

As the test sample flows through the absorbent device, the labelled antibody-dye conjugate binds to the PSA forming an antibody antigen complex. This complex binds to the anti-PSA antibody in the positive reaction zone (T) and produces a pink-rose colored band when PSA concentration is higher than 4 ng/mL. In the absence of PSA, there is no line in the positive reaction zone (T). The reaction mixture continues to flow through the absorbent device past the reaction zone and control zone. Unbound conjugate binds to the reagents in the control zone (C) producing a pink-rose colored band, demonstrating that the reagents are functioning correctly.

Test procedure

1. Allow samples and PSA-CHECK-1 test devices to come to room temperature prior to testing.
2. Remove the “reaction device” from its protective wrapper by tearing along the split.
3. Label device with the patient‘s name or control number.
4. Fill the serum dropper with specimens (serum, plasma or whole blood) and by holding it vertically, dispense one drop (25 μL) into sample well (▷). (If whole blood is used, dispense 2 drops (50 μL) into the sample well (▷) and wait for the whole blood sample to be completely absorbed before adding diluent.
5. Add exactly 3 full drops of diluent (150 μL) into the sample well (▷).
6. Read the results after 10 minutes. Do not interpret after 15 minutes.

Interpretation of the results

Negative result: Only one colored band appears on the control zone (C).

Positive result: Two clearly distinguishable lines appear (T and C).

Invalid result: If there is no distinct color band visible in the test and control windows, the test is inconclusive. It is recommended in this case to repeat the test.