Accu-Tell^® PSA Semi-quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: Semi-quantitative detection of Prostate Specific Antigen in whole blood, serum or plasma

Reading time: 5 minutes

Cut-off value: 3 ng/ml

Relative Sensitivity: 98.9%

Relative Specificity: 98.6%

Accuracy: 98.7%

INTRODUCTION

Prostate specific antigen (PSA) is produced by prostate glandular and endothelial cells. PSA has been detected in various tissues of the male urogenital system but only prostate glandular and endothelial cells secrete it. The PSA level in serum of healthy men is between 0.1 ng/mL and 2.6 ng/mL. It can be elevated in malignant conditions such as prostate cancer, and in benign condition such as benign prostatic hyperplasia and prostatitis. A PSA level of 3 to 10ng/ml is considered to be in the “gray-zone” and levels above 10ng/ml are highly indicative of cancer. Patients with PSA values between 3-10ng/ml should undergo further analysis of the prostate by biopsy.

INTENDED USE

ACCU-TELL^® PSA Semi-quantitative Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for semi-quantitative detection of Prostate Specific Antigen in whole blood, serum or plasma as aid in the diagnosis of prostate cancer and prostate infection of Benign Prostatic Hyperplasia (BPH). The test has a cut-off value of 3ng/ml and a reference value of 10ng/ml.

TEST PROCEDURE

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.

2. Place the cassette on a clean and level surface.

For Serum，Plasma or Venipuncture Whole Blood specimens:

Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40µL) or 2 drops of venipuncture whole blood (approximately 80µl) to the specimen well (S) of test cassette, then add 1 drop of buffer (approximately 40µL) and start the timer. See illustration above.

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 80µL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 µL) and start the timer. See illustration above.

3. Wait for the colored line(s) to appear*. Read results at 5 minutes.  Do not interpret the result after 10 minutes.

*Note: if migration is not observed in the result window after 30 seconds, add one or two extra drops of buffer.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL^® PSA Semi-quantitative Cassette (Whole Blood/Serum/Plasma) has been tested with a leading commercial PSA EIA Test using clinical samples.

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 for each of three lots using PSA specimen levels at negative, 3ng/ml and 20ng/ml. The specimens were correctly identified > 99% of the time.

Inter-Assay

Between-run precision has been determined by using the three PSA specimen levels at negative, 3ng/ml and 20ng/ml of PSA in 10 independent assays. Three different lots of ACCU-TELL^® PSA Semi-quantitative Cassette (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL^® PSA Semi-quantitative Cassette (Whole Blood/Serum/Plasma) has been tested for HAV+, HBV+, HIV+, HCV+, HEV+, Syphilis+, HAMA+, RF+, MONO+, Rubella, TOXO+, CMV+, CEA, and AFP+ positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following compounds have also been tested using ACCU-TELL^® PSA Semi-quantitative Cassette (Whole Blood/Serum/Plasma) and no interference was observed.

Ascoribic acid 200mg/l                 

Hemoglobin 1000mg/dl             

Gentistic acid 20mg/dl

Oxalic acid 60mg/dl               

Bilirubin 1000mg/dl            

Uric acid 200mg/l

Acetoaminophen 20mg/dl       

Aspirin 20mg/dl                         

Methanol 10%

Creatine 200mg/dl                   

Albumin 2000mg/dl                   

Caffeine 20mg/dl

LIMITATIONS

1. ACCU-TELL^® PSA Semi-quantitative Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of PSA in whole blood, serum or plasma specimen.

2. ACCU-TELL^® PSA Semi-quantitative Cassette (Whole Blood/Serum/Plasma) will only indicate the semi quantitative level 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.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.