[Study on the clinical use of alpha-fetoprotein (AFP) colloidal gold diagnostic strip].
OBJECTIVE
To test the sensitivity and specificity of alpha-fetoprotein (AFP) colloidal gold diagnostic strip as compared with RIA-AFP diagnostic kit.


METHODS
Double blind method was used to test sera from 426 healthy people and 1567 patients selected in two general hospitals and a cancer hospital. Each serum was measured by RIA-AFP and AFP colloidal gold diagnostic strip on the same day. RIA-AFP diagnostic results was identified as true positive or negative.


RESULTS
Among 426 healthy people, all the RIA-AFP test showed negative result (serum AFP concentration less than 25 IU/ml), but the AFP colloidal gold diagnostic strip had 1.88% false positive. When comparing the result from 1567 patients measured by RIA-AFP, the sensitivity and specificity of AFP colloidal gold diagnostic strip were 99.3%, and 97.2%, respectively. The crude correspondence rate between the two diagnostic regents was 97.6%.


CONCLUSIONS
AFP colloidal gold diagnostic strip showed very good result and could be used as a screening diagnostic kit in clinic and hospital settings.
Jiang
Xian-min
XM
Beijing Institute of Biological Prodects, Beijing 100024, China.
Kong
Jian
J
Lin
Tao
T
Yu
Xiu-ying
XY
Chen
Ying
Y
Dai
Yu
Y
Yang
Hang-yan
HY
Sun
Xiao-li
XL
Yang
Jian
J
Yang
Yong-quan
YQ
Zhang
Yan-chun
YC
D014408:Biomarkers, Tumor / Q000097:blood*; D006528:Carcinoma, Hepatocellular / Q000175:diagnosis*; D004311:Double-Blind Method; D017979:Gold Colloid; D006801:Humans; D008113:Liver Neoplasms / Q000175:diagnosis*; D011863:Radioimmunoassay; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D000509:alpha-Fetoproteins / Q000032:analysis*
D014408:Biomarkers, Tumor; D017979:Gold Colloid; D011933:Reagent Kits, Diagnostic; D000509:alpha-Fetoproteins; C058457:Aurodye