20 individually packed test cassettes for detection of prostate-specific antigen (PSA) in human serum, plasma or whole blood specimens with a cut-off of 4 ng/mL.
Package contents:
20 test cassettes
20 disposable pipettes
1 buffer
1 package insert
Exclusively for professional users
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The NADAL® PSA Test is a rapid visual immunoassay for the semiquantitative presumptive detection of prostate-specific antigen (PSA) in human serum, plasma or whole blood specimens with a cut-off of 4 ng/mL. The test detects total PSA (tPSA). The NADAL® PSA Test is intended for use as an aid in the diagnosis of prostate cancer by professional users as elevated PSA levels frequently indicate an increased risk of prostate carcinomas.
Prostate cancer is the most frequent type of cancer found in men and the third most common cause of death due to cancer in men in Germany. Age-standardised incidences of prostate cancer differ worldwide. In Europe there is a decline from North to South. In the USA, incidences of prostate cancer are the highest, with Afro-American males especially affected. Incidences increase dramatically in males over 40 years of age, occurring in 50% of those over 70 years. The introduction of PSA as a tumor marker has led to a significant increase in the detection of prostate carcinomas, especially those in early stages. Looking at PSA from a biological viewpoint, it is a 33 kDa protein that is synthesised in the prostatic gland. It functions as a serine protease and serves to liquefy the seminal fluid. It is 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 (BPH) and prostate carcinoma, but rarely in healthy men. PSA is almost absent in the serum of healthy women. The PSA level in serum or plasma of normal healthy men should be lower than 4 ng/mL. If the structural integrity of the prostate is disturbed and/or the gland size is increased, the amount of PSA in blood/serum/plasma may rise, reaching levels of up to 200 ng/mL. At the cut-off of 4 ng/mL PSA, further medical analysis is recommended, even though in the PSA concentration range of 4-10 ng/mL the elevated levels are frequently not caused by cancer but by other factors, such as benign prostatic hyperplasia or prostatitis. PSA concentrations of >10 ng/mL strongly indicate the presence of prostatic carcinoma. Although an ethnical and/or age-specific modification of the cut-off has been discussed in the literature, the PSA amount of 4 ng/mL is the generally accepted value at which follow-up examinations of the patient should be carried out.
