CTK Biotech, USA PSA Semi-quantitative Rapid 30 Test

The OnSite  PSA Semi-quantitative Rapid Test is a lateral flow chromatographic immunoassay for the semi-quantitative detection of prostate specific antigen (PSA) in human whole blood, serum or plasma at a cut-off level of 4 ng/mL.

• Non-invasive screening method for prostate cancer
• Three-line test result to facilitate determination of patient’s PSA level
• A cut-off value of 4 ng/mL and a reference value of 10 ng/mL for easy interpretation of the semi-quantitative test result
• The test results should be read within 15 minutes after a specimen is applied to the sample well of the device. Reading the result after 15 minutes may give erroneous results.
• Store between 2-30°C

Each kit contains:

• Individually sealed foil pouches containing:
  • One cassette device
  • One desiccant
• Plastic droppers
• Sample diluent (REF SB-R2002, 5 mL/bottle)
• One package insert (instruction for use)

TEST PRINCIPLE : The OnSite PSA semi-quantitative Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing monoclonal antiPSA antibodies conjugated with colloidal gold (PSA antibody conjugates) and rabbit IgG, 2) a nitrocellulose membrane strip containing a test line (T line), a reference line (R line) and a control line (C line). The T line is pre-coated with a polyclonal anti-PSA antibody, the R line is coated with goat anti-rabbit IgG antibody, and the C line is pre-coated with goat anti-mouse IgG antibody. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the test cassette. PSA, if present in the specimen, will bind to the PSA antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-PSA antibodies. If the PSA level is between 4-10 ng/mL, the immunocomplex will form a visible burgundy colored T line with its line intensity weaker than the reference line (R). If the PSA level is equal to or higher than 10 ng/mL, the immunocomplex will form a burgundy colored T line with its line intensity equal to or higher than that of the reference line (R). Absence of the T line suggests the PSA level is lower than 4 ng/mL. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of goat anti-mouse IgG/mouse IgG-gold conjugate regardless of color development on the T line. If the C line does not develop, the test result is invalid and the specimen must be retested with another device.