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PSA Serum Test Cassette

Catalog No.       Product Name

ABT-TM-B20      PSA Serum/Plasma Test Cassette


INTENDED USE

ACCU-TELL® Rapid PSA Prostate Specific Antigen Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Prostate Specific Antigen in serum or plasma.


PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Rapid PSA Prostate Specific Antigen Test Cassette (Serum/Plasma) has been tested with a leading commercial PSA EIA Test using clinical sample.

Method

ELISA

Total Results

ACCU-TELL® Rapid PSA Test Cassette (Serum/Plasma)

Results

Positive

Negative

Positive

178

4

182

Negative

2

282

284

Total Results

180

286

466

Relative Sensitivity: 98.9% (95%CI*: 96.0%-99.9%)

Relative Specificity: 98.6% (95%CI*: 96.5%-99.6%)

Accuracy:98.7%(95%CI*:97.2%-99.5%)*95%  Confidence Intervals

Precision

Intra-Assay

Assays were carried out to determine assay reproducibility using replicates of 10 tests in three different runs for each of three lots using PSA specimen levels at 0ng/ml, 2ng/ml, 4ng/ml, 10ng/ml and 20ng/ml. The specimens were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by using the five PSA specimen levels at 0ng/ml, 2 ng/ml, 4 ng/ml, 10 ng/ml and 20 ng/ml of PSA in 3 independent assays. Three different lots of ACCU-TELL® Rapid PSA Prostate Specific Antigen Test Cassette (Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Interfering Substances

The following substances do not interfere with the test results at the indicated concentrations: Ascorbic Acid at 200mg/l, Hemoglobin at 10g/l, Triglyceride at 30g/l, Bilirubin at 1,000mg/dl, Uric Acid at 200mg/l.

LIMITATIONS

  1. ACCU-TELL® Rapid PSA Prostate Specific Antigen Test Cassette (Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of PSA in serum or plasma specimen.

  2. ACCU-TELL® Rapid PSA Prostate Specific Antigen Test Cassette (Serum/Plasma) will only indicate the presence of PSA in the specimen and should not be used as the sole criteria for the diagnosis of Prostate Cancer.

  3. A significant numbers of patients with BPH (more that 15%) and less than 1% of healthy individuals have elevated PSA. Even if the test results are positive, further clinical evaluation should be considered with other clinical information available to the physician.

  4. PSA levels may be unreliable in patients who receive hormone therapy or prostate gland manipulation.

  5. High concentrations of PSA may produce a dose hook effect, resulting in false negative results. High dose hook effect has not been observed with this test up to 30,000ng/ml PSA.