Shipped on ice packs. Upon receipt, store the product at the temperature recommended below.
Store the complete kit at 2–8°C. Under these conditions, all components are stable until the expiration date (see label on the box).
0 - 1.56 - 3.12 - 6.25 - 12.5 - 25 ng/mL
Limit of Detection
98 - 108%
85 - 115%
The kits are CE-IVD certified and intended for professional use.
European Union: for in vitro diagnostic use
Rest of the world: for research use only!
The total assay time is less than 1.5 hours
Quantitative determination of total PSA concentration in human serum or
Assay format is 96 wells
Quality Controls (high and low) are ready to use
Calibrators are ready to use
For routine analysis
Immune Response, Infection and Inflammation, Oncology
Prostate cancer is the most frequent type of cancer found in man and is the second cause of death due to cancer in males. Until recently, digital rectal examination (DRE) was frequently used as only diagnostic modality for the detection of early stages of prostate cancer. In the recent years the determination of serum PSA levels has become the most accepted method to improve the diagnostic specificity of DRE. Although PSA is a tissue specific protein and is not solely tumor specific, it has become the most important marker for prostate carcinoma, showing a better specificity than other biochemical markers used in this context (PAP, total alkaline phosphatase, carcinoembryonic antigen, etc.) In 1979, Wang et al. isolated a specific antigen for normal prostate tissue and called this protein PSA. PSA is a 33 kDa serine proteinase. Immunohistological studies have shown that 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 metastatic prostate cancer and in seminal plasma. If the structural integrity of the prostate is disturbed and/or the gland size is increased, the amount of PSA in the blood plasma may become elevated. An elevation of PSA levels to values higher than 3-4 ng/ml has been reported for patients with either benign prostatic hypertrophy (BPH) or prostate carcinoma. At this threshold follow-up examinations that allow to differentiate between these two conditions are recommended.
The determination of PSA serum levels is not only important for the screening of patients for prostate cancer, but also for monitoring patients that have been treated for this disease. Here regular PSA measurements are an important tool to examine the potential and actual effectiveness of surgery or other therapies. An increase of PSA in patients after radical prostatectomy or radiotherapy may allow an earlier discovery of residual or recurrent carcinoma.
Instructions for Use (RUO)
Instructions for Use (RUO)
Safety Information (RUO)
CE IVD Assays
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