The LOMINA Prostate Cancer Protein Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection o f prostate specific antigens. This kit is intended for use as an aid in the diagnosis of prostate cancer.
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 I 0 ng/ml. If the structural integrity of the prostate is disturbed and/or the gland size is increased, the amount f 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 PS.A, 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 ofprostatic 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.
The test is developed and tested for the use of serum, plasma and whole blood samples.
Test duration: 15 min
IVD category: IVD other
Disease category: Tumor markers
The LOMINA Prostate Cancer Protein Rapid Test Device (Whole Blood/Serum/Plasma) 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/rnL. A test band (T) signal equal or close to the reference band (R) indicates that the PSA level in the specimen is approximately IO ng/rnL. A test band (T) signal stronger than the reference band (R) indicates that the PSA level in the specimen is above 10 ng/rnL. The appearance of a colored band at the control region serves as a procedural controi indicating that the proper volume of specimen has been added and membrane wicking has occurred.