Good Sensitivity Cancer Marker Test 2.0 Ng/ml For Prostate Specific Antigen

Good sensitivity Tumor Marker Prostate specific antigen (PSA) rapid test, 4mm Strip, blood test

PSA Rapid Diagnostic Test strip

Intended Use:

The PSA Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of prostate specific antigen (PSA) in human serum or plasma at a cut-off level of 2.0 ng/mL. It is intended to be used as a screening test and as an aid in the diagnosis of prostate cancer. Any reactive specimen with the PSA Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY:

PSA is a serine protease with a molecular weight of approximately 34,000 daltons containing 7% carbohydrate by weight. PSA is immunologically specific for prostatic tissue, exiting in normal, benign hyperplasic, in malignant prostate tissue, in metastatic prostate carcinoma, and in prostate fluid and seminal plasma. PSA is not present in any other normal tissues.

Elevated serum PSA concentration has been reported in patients with prostate cancer, benign prostate hypertrophy, or inflammatory conditions of other adjacent genitourinary tissues, but not in apparently healthy men, men with non-prostate carcinoma, apparently healthy women, or women with cancer. Studies have suggested that serum PSA is one of the most useful tumor markers in oncology. PSA measurements can enhance early prostate cancer detection when combined with digital rectal examination (DRE). It may also serves as an accurate marker for assessing response to the treatment of prostate cancer. Therefore, measurement of serum PSA concentration can be an important tool in monitoring patients with prostate cancer and in determining the potential and actual effectiveness of surgery or other therapies.

Test Principle:

The PSA Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing anti-PSA antibody conjugated with colloid gold (PSA antibody conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with polyclonal anti-PSA antibody, and the C band 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. Elevated 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, forming a burgundy colored T band, indicating a PSA positive test result.

Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat antimouse IgG/mouse IgG-gold conjugate regardless of color development on the T band. Otherwise, the test result is invalid and the specimen must be retested with another device.

TEST PROCEDURE

Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

Step 3: Be sure to label the device with specimen’s ID number.

Step 4: Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 23 drops (about 60- 90 µL) of specimen into the sample well making sure that there are no air bubbles.

INTERPRETATION OF RESULTS

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

PERFORMANCE CHARACTERS:

Sensitivity and Specificity

The PSA Rapid Test Cassette (Whole blood /Serum /Plasma) has been tested with a leading commercial PSA EIA Test using clinical samples.

Relative Sensitivity: 99.0% (95%CI:*96.6%-99.9%) *Confidence Intervals

Relative Specificity: 99.2% (95%CI:*97.5%-99.8%)

Overall accuracy: 99.1% (95%CI:*97.9%-99.7%)