[Preparation and evaluation of a time-resolved fluoroimmunoassay kit for CA50 determination].
OBJECTIVE
To prepare a rapid and sensitive diagnostic kit for detection of CA50 based on time-resolved fluoroimmunoassay.


METHODS
A sandwich-TRFIA diagmostic kit was developed using anti-CA50 monoclonal antibody and all parameters of the kit were evaluated.


RESULTS
The linear measurement range of the kit was (5 - 300) U/ml. The sensitivity was 0.2 U/ml. The intra- and inter-assay coefficients of variation were 4.3% - 8.2% and 7.7% - 11.2%, respectively. There was no cross-reaction with CEA, CA12-5, CA15-3 and AFP. The cross reactivity with CA19-9 was 0.7 U/ml. The correlation coefficient of detection results of 107 blood samples between this newly developed kit and commercially available CA50 RIA kit was 0.901.


CONCLUSIONS
This newly developed CA50-TRFIA kit is a valuable test tool for clinical application with even better sensitivity, specificity and accuracy.
Hang
Jian-feng
JF
School of Biotechnology, Southern Medical University, Guangzhou 510515, China.
Wu
Ying-song
YS
Xu
Wei-wen
WW
Yu
Wei-hong
WH
Huang
Ying
Y
Li
Ming
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015295:Antigens, Tumor-Associated, Carbohydrate / Q000097:blood*; D005260:Female; D015200:Fluoroimmunoassay / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D011863:Radioimmunoassay; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012015:Reference Standards; D015203:Reproducibility of Results
D015295:Antigens, Tumor-Associated, Carbohydrate; C082699:CA-50 antigen; D011933:Reagent Kits, Diagnostic