PSA Prostate Specific Antigen Rapid Test Device Package Insert
Prostate specific antigen (PSA) is produced by prostate glandular and endothelial cells. It is a single chain glycoprotein with a molecular weight of approximately 34 kDa.1 PSA exists in three major forms circulating in the serum. These forms are free PSA, PSA bound to α1–Antichymotrypsin (PSA-ACT) and PSA complexed with α2–macroglobulin (PSA-MG).2
PSA has been detected in various tissues of the male urogenital system but only prostate glandular cells and endothelial cells secrete it. The PSA level in the 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 conditions such as benign prostatic hyperplasia and prostatitis. A PSA level of 4 to 10 ng/mL is considered to be in the “gray-zone” and above 10 ng/mL is highly indicative of cancer.3 Patients with PSA values between 4-10 ng/mL should undergo further analysis of the prostate by biopsy. Authorities have begun to explore the possibility of using PSA levels lower than 4.0 ng/mL as the upper limit of normal for screening examinations. By lowering the PSA cutoff from 4 to 3 ng/mL, an increase in cancer detection by 13.2% can be achieved.4
The prostate specific antigen test is the most valuable tool available for the diagnosis of early prostate cancer. Many studies have confirmed that the presence of PSA is the most useful and meaningful tumor marker known for prostate cancer and prostate infection of Benign Prostatic Hyperplasia (BPH).5
The PSA Ultra Prostate Specific Antigen Rapid Test Device (Whole Blood/Serum/Plasma) utilizes a combination of colloidal gold conjugate and anti-PSA antibodies to selectively detect all three forms of PSA in whole blood, serum or plasma. The test has a cut-off value of 4 ng/mL.
The PSA Ultra Prostate Specific Antigen Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative, 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, 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. The presence of this colored line in the test region indicates that presence of PSA in the specimen is more than 4 ng/mL for a positive result, while its absence indicates a negative result or presence of PSA in the specimen below 4 ng/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.
|Individually packed test devices||Each device contains a strip withcolored conjugates and reactive reagents pre-spreaded at the corresponding regions.|
|Disposable pipettes||For adding specimens use.|
|Buffer||Phosphate buffered saline and preservative|
|Package insert||For operation instruction.|
|Test devices||Disposable specimen droppers.|
Materials Required But Not Provided
|Specimen collection containers||Lancets (for fingerstick whole blood only)|
|Centrifuge (for plasma only)||Timer|
|Disposable heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)|
★ For professional in vitro diagnostic use only. Do not use after expiration date.
★ The test should remain in the sealed pouch until use.
★ Do not eat, drink or smoke in the area where the specimens or kits are handled.
★ Do not use test if pouch is damaged.
★ Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
★ Wear protective clothing such as laboratory coats, disposable gloves or eye protection when specimens are being tested.
★ Humidity and temperature can adversely affect results.
★ The used test should be discarded according to local regulations.
Storage and Stability
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
Specimen Collection and Preparation
✽ The PSA Prostate Specific Antigen Rapid Test Device (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick), serum, or plasma.
✽ To collect Fingerstick Whole Blood specimens:
1.Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
2.Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
3.Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
4.Add the Fingersitck Whole Blood specimen to the test device by using a capillary tube or hanging drop.
✽ Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.
✽ Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
✽ Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
✽ If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.
Directions for Use
Allow test device, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1.Bring the pouch and buffer to room temperature before opening the pouch. Remove the test device from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2.Place the test device on a clean and level surface.
For Serum, Plasma or Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 1 drop of serum/plasma (approximately 40 L) or 2 drops of venipuncture whole blood (approximately 80 L) to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40 L) and start the timer.
For Fingerstick Whole Blood specimens:
·To use a capillary tube: Fill the capillary tube and transfer approximately 80 L of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40 L) and start the timer.
·To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 80 L) to fall into the center of the specimen well (S) on the test device, then add 1 drop of buffer (approximately 40 L) and start the timer. See illustration below.
3.Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not interpret the result after 10 minutes.
Interpretation of Results
|* A colored band appears in the control band region (C) and another colored band appears in the T band region.|
|One colored band appears in the control band region (C). No band appears in the test band region (T).|
|Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.|
1.The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level cannot be determined by this qualitative test.
2.Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.
★ A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
★ Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
1.The PSA Prostate Specific Antigen Rapid Test Device (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the qualitative detection of PSA in whole blood, serum or plasma specimens.
2.The PSA Prostate Specific Antigen Rapid Test Device (Whole Blood/Serum/Plasma) will only indicate the 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.
The generally accepted minimum indicative level of PSA for Prostate Cancer is 4 ng/mL and the accepted warning level is 10 ng/mL. Local regulations may define different reference levels, please consult with authorities for specifics. The PSA Prostate Specific Antigen Rapid Test Device (Whole Blood/Serum/Plasma) has been compared with a leading commercial PSA enzyme immunoassay (EIA) test. The correlation between these two systems is 98.6%.
Sensitivity and Specificity
The PSA Prostate Specific Antigen Rapid Test Device (Whole Blood/Serum/Plasma) has been tested with a leading commercial PSA EIA test using clinical specimens.
|Ultra PSARapid Test Device||Results||Positive||Negative|
Relative Sensitivity: 98.7% (95.4%-99.8%)* Relative Specificity: 98.5% (96.3%-99.6%)*
Accuracy: 98.6% (97.0%-99.5%)* *95% Confidence Interval
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 0 ng/mL, 3 ng/mL, 10 ng/mL and 20 ng/mL. The specimens were correctly identified 98% of the time.
Between-run precision has been determined by using the five PSA specimen levels at 0 ng/mL, 3 ng/mL 10 ng/mL and 20 ng/mL of PSA in 3 independent assays. Three different lots of the PSA Prostate Specific Antigen Ultra Rapid Test Device (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified 98% of the time.
The following substances do not interfere with the test results at the indicated concentrations: Ascorbic Acid at 200 mg/L, Hemoglobin at 10 g/L, Triglyceride at 30 g/L, Bilirubin at 1,000 mg/dL, Uric Acid at 200 mg/L.
1.Wang MC, Valenzuela LA, Murphy GP, et al., Purification of human prostate specificity antigen. Invest Urol 1979; 17: 159-163.
2.Christens A, Laurell CB, Lilja H. Enzymatic activity of prostate –specific antigen and its reaction with extracellular serine proteinase Inhibitors. Eur J Biochem 1990; 194:755-763.
3.Catalona WJ, Southurick PC, Slawin KM, et al., Comparison of percent free PSA, PSA density and age-specific PSA cut-offs for prostate cancer detection and staging. Urology 2000 Aug 1:56(2):255-60.
4.Lodding P, Aus G, Bergdahl S, et al. Characteristics of screening detected prostate cancer in men 50 to 66 years old with 3 to 4 ng./mL. prostate specific antigen. Journal of Urology 159(3): 899-903, 1998.