High Accuracy Tumor Mark PSA Rapid cassette, for detecting Prostate specific antigen in serum, gold colloidal method

Product Name: PSA Rapid Diagnostic Test

Intended Use:

The PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Cassette (Whole Blood

/Serum /Plasma) is a rapid chromatographic immunoassay for semi-quantitative detection of Prostate Specific Antigen in whole blood, serum or plasma.

Test Principle:

The PSA Rapid Test Cassette (Whole Blood /Serum /Plasma) is a semi-quantitative, membrane based immunoassay for the detection of PSA in whole blood, serum or plasma. The membrane is pre-coated with PSA antibodies on the test line region. During testing, the specimen reacts with the particle coated with anti-PSA antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-PSA antibodies on the membrane and generate a colored line. A test line (T) intensity weaker than the reference line (R) indicates that the PSA level in the specimen is between 3-10ng/ml. A test line (T) intensity equal or close to the reference line (R) indicates that the PSA level in the specimen is approximately 10ng/ml. A test line (T) intensity stronger than the reference line (R) indicates that the PSA level in the specimen is above 10ng/ml. To serve as a procedural control, a colored line will always appear in the control line region (C) indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to begin testing.

2. Remove the device from the sealed pouch and lay it on a flat and dry surface.

3. Using the provided pipette, add one drop of fresh specimen to the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Read the result between 15-20minutes. Do not read results after 20 minutes.

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%)