Prostate Specific Antigen PSA Rapid Test Kit Prostate Cancer One Step Diagnosis

Prostate Specific Antigen PSA Rapid Test Kit One Step Diagnosis of Prostate Cancer

INTENDED USE
The PSA Rapid Test Kit (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of prostate specific antigens in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of prostate cancer.

INTRODUCTION

Prostate cancer is the most frequent type of cancer found in the man and the second cause of death due to the cancer in man. Prostate cancer incidences increase dramatically in males with an age over 40 years, occurring in 50% of those over 70 years. Compared to other cancers, prostate cancer is more successfully treated if diagnosed early. Recently, another prostate enzyme has been identified and purified, which specific for prostate tissue, normal or malignant, and also found in periurethral glands. This enzyme is called prostate specific antigen (PSA). Looking at PSA from the biological side, it is a 33 kDa protein that is synthesized in the prostatic gland. It functions as a serine protease and serves to liquefy the seminal fluid. As demonstrated by immunohistological studies, PSA is localized in the cytoplasm of prostate acinar cells, ductal epithelium and in the secretion on the ductal lumina, present in normal, benign hyperplastic and malignant prostate tissues as well as in metastatic prostate cancer and in seminal fluid. An elevation of the serum concentration is reported in patients with both benign prostatic hypertrophy prostate carcinoma, but rarely in healthy men and is absent in normal women. PSA is not present in any other normal tissue obtained from men, nor is it produced by cancers of the breast, lung, colon, rectum, stomach, pancreas and thyroid. The PSA level in serum or plasma of normal health men should be lower than 4 ng/ml, so the reference line is designed to be approximately the intensity of 10 ng/ml. If the structural integrity of the prostate is disturbed and/or the gland size is increased, the amount of PSA in the blood serum/plasma may become elevated, reaching levels up to 200 ng/ml PSA. At a cut-off of 4 ng/ml PSA, further medical analysis is recommended, although at a concentration range between 4-10 ng/ml PSA the elevated levels are commonly not caused by cancer but by other factors like benign prostatic hyperplasia or prostatitis. Plasma concentrations of >10 ng/ml PSA strongly indicate the presence of prostatic carcinoma. Although a race- and/or age-dependent modification of the cut-off has been discussed in the literature, the amount of 4 ng/ml PSA is the generally accepted value at which follow-up examinations of the patient should be started.

TEST PRINCIPLE
The PSA Rapid Test Kit detects prostate specific antigens through visual interpretation of color development on the internal strip. PSA antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with PSA antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient PSA in the specimen, a colored band will form at the test region of the membrane. A test band (T) singal weaker than the reference band (R) indicates that the PSA level in the specimen is between 4-10 ng/mL. A test band (T) signal equal or close to the reference band (R) indicates that the PSA level in the specimen is approximately 10 ng/mL. A test band (T) signal stronger than the reference band (R) indicates that the PSA level in the specimen is above 10 ng/mL. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

MAIN CONTENTS
• Rapid test Cassette with desiccant.
• Buffer

• Pipette
• Instruction Manual

STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 18 months.

PRECAUTIONS
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local regulations.

SAMPLE COLLECTION

• The PSA Rapid Test Kit is intended for use with human whole blood, serum, or plasma specimens only.

• Intake of Finasteride (5-reductaseinhibitor) will reduce the PSA concentration by max. 50%. This should be considered by the interpretation of the results.

• Different factors could increase the PSA level in blood serum and should be avoided before collection of the blood sample and/or should be desisted from by the patient before sample taking

• Ride on a bicycle: 24 hours before taking of blood sample

• Sexualactivities (Ejaculation): 24-48 hours before taking of blood sample

• Every manipulation of the prostate by medical examinations. The following intervals are recommended until taking of blood sample:

• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.

• Perform testing immediately after specimen collection. Do not leave 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.

• Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.

• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.

• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.

OPERATION

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

• Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.

• Transfer 1 drops of serum/plasma to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer, and start the timer.

OR

Transfer 2 drops of whole blood to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer, and start the timer.

OR

Allow 2 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S) of the test device, then add 1 drop of buffer, and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, color will migrate across the membrane.

• Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION


PERFORMANCE
Sensitivity 98.3%

Specificity 98.0%

For detailed information, please contact Dewei person for Manual Instruction.