Prostate Specific Antigen
Method: Immunoturbidimetric Liquid
reagent, R1: R2=2:1
CLINICAL SIGNIFICANCE
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. 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.
Serial measurement of PSA concentration in
the serum is an important tool in monitoring patients with prostate cancer and
determining the potential and actual effectiveness of surgery or other therapies
or may allow for earlier discovery of residual or recurrent carcinoma after
radical prostatectomy or radiotherapy.
PRECISION
|
Intra assay precision |
Inter assay precision |
||||||
|
N=20 |
level 1 |
level 2 |
level 3 |
N=5 |
Batch 1 |
Batch 2 |
Batch 3 |
|
Mean (ng/ml) |
8.47 |
13.72 |
29.7 |
Mean (ng/ml) |
13.67 |
13.02 |
13.54 |
|
SD |
0.10 |
0.11 |
0.47 |
`c |
13.41 |
||
|
CV (%) |
1.18% |
0.80% |
1.58% |
(Xmax-Xmin) /`c |
4.85% |
||
Sensitivity
For analysis sensitivity, the absorbance change rate (△A/min) should more than 0.1000 under sample concentration of 25ng/mL.
Correlation
The correlation of a well-known brand(X) and Gcell(Y) is y = 0.8604x + 0.0262, R² = 0.9866
Interference
|
Analytes |
Concentration |
|
Bilirubin |
18.9 mg/dl |
|
Hemoglobin |
490 mg/dl |
|
Lipermia |
1900 |
|
RF |
500 IU/ml |
Linearity
Linearity up to 100ng/ml.