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Prostate Specific Antigen (tPSA)
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Prostate Specific Antigen (tPSA)
The Quantitative Determination of Prostate Specific Antigen (tPSA) Concentration in Human Serum by a Chemiluminescence Immunoassay
Summary and explanation of the test
Prostate specific Antigen (PSA) is a serine protease with chymotrypsin-like activity. The protein is a single chain glycoprotein with a molecular weight of 28.4 kD. PSA derives its name from the observation that it is a normal antigen of the prostrate but is not found in any other normal or malignant tissue.
PSA is found in benign, malignant and metastatic prostrate cancer. Since prostate cancer is the second most prevalent form of male malignancy, the detection of elevated PSA levels plays an important role in the early diagnosis. Serum PSA levels have been found to be more useful than prostatic acid phosphatase (PAP) in the diagnosis and management of patients due to increased sensitivity and specificity.
The employment of several serum references of known prostate specific antigen (PSA) levels permits the construction of a dose response curve of activity and concentration. From comparison to the dose response curve, an unknown specimen’s activity can be correlated with PSA concentration.
Materials provided for 96-well microplate
1. | Microplate | 1 piece | 96 test/piece |
2. | Calibrators | 6 tubes | 0.5 mL/tube |
Concentrate:0,0.7,2.1,7,21,70ng/ml | |||
3. | Label | 1 bottle | 16 mL/bottle |
4. | Substrate A Substrate B | 1 bottle 1 bottle | 6 mL/bottle 6 mL/bottle |
Before using, the substrates A and B are mixed by equal volume in practicality requisite amount. | |||
5. | Washing buffer | 1 bottle | 20 mL/bottle |
Before using, being diluted to 600ml with distilled water | |||
6. | Instruction book | 1 piece | 1 piece/kit |
Keeping in 2~8Degree Celsius, is 12 months.
Specimen collection and preparation
The specimens shall be blood serum in type and the usual precautions in the collection of venipuncture samples should be observed. For accurate comparison to established normal values, a fasting morning serum sample should be obtained. The blood should be collected in a plain red-top venipuncture tube with or without gel barrier. Allow the blood to clot. Centrifuge the specimen to separate the serum from the cells. Samples may be refrigerated at 2~8Degree Celsius for a maximum period of five days. If the specimen can not be assayed within this time, the sample may be stored at temperatures of -20Degree Celsius for up to 30 days. Avoid repetitive freezing and thawing.
Test procedure
The kit is in room temperature for more than 15mins, then
Unit:μL
Microplate Blank well Standards well Samples well |
Calibrators — 25 — Specimens — — 25 Label — 150 150 |
Swirl the microplate gently for 2mins to mix and cover, incubate 45 mins at 37Degree Celsius. After washing for 5 times, the substrates are added. |
Substrate A 50 50 50 Substrate B 50 50 50 |
Or we also can mix the substrates in a bottle before using, and then pipette 100μL to each wells. |
Swirl and detect |
Detect After substrates being pipetted, suggest detecting in 1-3 mins by luminometer, one second per well. |
The data of concentrate and RLU is fitted in linear by log(X)- log(Y).
Expected values for the PSA (in ng/mL)
Healthy and non-pregnant subjects: less than 4ng/mL
Performance characteristics
A: Precision
With assay precision is less than 10%, between assay precision is less than 15%.
B: Accuracy
Between 90%-110%
C: Sensitivity
Less than 0.4ng/ml
Manufacturing enterprise: Beijing Savant Biotechnology Co., Ltd.
Prostate Specific Antigen (tPSA)
