Prostate Specific Antigen, Human (PSA, Kallikrein-3, Seminin, Semenogelase, ?-Seminoprotein, KLK3) B

PSA ELISA Kit is to be used for the in vitro quantitative determination of human Prostate-Specific Antigen (PSA) concentrations in serum. Prostate-Specific Antigen (PSA) is a single-chain glycoprotein weighing approximately 34kD1. PSA is a secretion of the prostate epithelium produced by normal, benign, and cancerous cells2. PSA is functionally and immuno-chemically distinct from Prostatic Acid Phosphatase. Development of an enzyme immunoassay3 has made it possible to accurately detect low concentrations of PSA in the blood of patients with malignant and benign prostate disease. PSA serum levels are elevated in patients with prostate cancer, benign prostatic hypertrophy (BPH) and inflammatory conditions associated with the surgical stage and metastasis of the disease. After several years of clinical use, PSA has emerged as the choice overall serum marker for prostate cancer. Furthermore, numerous investigators consider SA to be the most useful and meaningful tumor marker in cancer biology. This PSA ELISA Kit is intended for use as a diagnostic serum marker for prostate cancer and represents a valuable new tool for the clinician. When used in combination with the digital rectal exam and/or transrectal ultrasound, PSA may assist in early detection programs for prostate cancer. Additionally, costly and time-consuming bone scans can be avoided for patients with newly diagnosed and untreated prostate cancer. The latter assumes a negative bone scan and therefore, a staging bone scintigram may not be necessary. Finally, an ultra-sensitive PSA assay would be useful when monitoring patients for residual disease following radical prostatectomy, as well as earlier detection of recurrent active isease following such therapies PERFORMANCE CHARACTERISTICS, 1. PRECISION, Within-run coefficients of variation (cv) are 2.5-4.05%., Between-run coefficients of variation (cv) are 4.0-4.5%., 2. SENSITIVITY, Estimated to be 1ng/ml PSA antigen in human serum., 3. SPECIFICITY, No cross-reaction can be found in our assay., 4. RECOVERY, The recovery range was 95-100%., 5. HOOK EFFECT, In this assay, no hook effect occurs until the concentration of PSA reaches 10,000ng/ml., 6. EXPECTED NORMAL VALUES, Each laboratory must establish its own normal range of values based on patient populations. Differences in assay techniques and the use of various standards may affect the results. The expected PSA normal value of this kit is less than 4.0ng/ml., 7. CALIBRATION, This immunoassay is calibrated against NIBSC/WHO PSA First International Standard (Code 96/670). Kit Components: P9054-11A Microdtiter Plate 1x96 wells., P9054-11B PSA (HRP) 1x12ml , P9054-11C PSA Standard, 80ng/ml 1x1 vial , P9054-11D PSA Standard, 40ng/ml 1x1 vial , P9054-11E PSA Standard, 20ng/ml 1x1 vial , P9054-11F PSA Standard, 10ng/ml 1x1 vial , P9054-11G PSA Standard, 2ng/ml 1x1 vial , P9054-11H PSA Standard, 0ng/ml 1x1 vial , P9054-11J Substrate A 1x10ml , P9054-11K Substrate B 1x10ml , P9054-11L Stop Solution 1x15ml , P9054-11M Sample Diluent 1x10ml , Storage and Stability: Store kit components at 4°C. P9054-11C -P9054-11H are stable for at least 3 months after reconstitution. For maximum recovery of product, centrifuge the original vial prior to removing the cap.