Evaluation of an automated immunochemical fecal occult blood test for colorectal neoplasia detection in a Chinese population.
BACKGROUND
Most commercial fecal occult blood tests (FOBT) used for colorectal carcinoma screening of Western populations are guaiac-based, manually developed, subjective, and sensitive to dietary components. Preliminary studies demonstrated the unsuitability of these tests for screening a Chinese population. The goal of the current study was to evaluate the performance characteristics of a human hemoglobin-specific automated immunochemical FOBT, the Magstream 1000/Hem SP (Fujirebio, Inc., Tokyo, Japan), in a Chinese population referred for colonoscopy.


METHODS
Two hundred fifty consecutive patients who were referred for colonoscopy and met the study inclusion criteria provided samples for the immunochemical FOBT (without dietary restrictions) from two successive stool specimens. Tests were developed with an automated instrument that had an adjustable sensitivity threshold. The sensitivity, specificity, and positive predictive value for detecting colorectal adenomas and carcinomas were calculated according to the manufacturer's instructions over a range of sensitivity levels.


RESULTS
At the optimal threshold level, the sensitivity, specificity, and positive predictive value for detection of significant colorectal neoplasia (adenomas >or= 1.0 cm and carcinomas) were 62%, 93%, and 44%, respectively. The test was easy to use, and results did not depend on operator experience.


CONCLUSIONS
The automated immunochemical FOBT used in the current study was a robust, convenient, and useful tool for colorectal carcinoma screening in the study population.
Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
Wai Man
WM
Wong
Shiu Kum
SK
Lam
Kwan Lok
KL
Cheung
Teresa Sze Man
TS
Tong
Paul
P
Rozen
Graeme P
GP
Young
Kin Wah
KW
Chu
Judy
J
Ho
Wai Lun
WL
Law
Hiu Ming
HM
Tung
Hok Kwok
HK
Choi
Yee Man
YM
Lee
Kam Chuen
KC
Lai
Wayne H C
WH
Hu
Chi Kuen
CK
Chan
Man Fung
MF
Yuen
Benjamin Chun-Yu
BC
Wong
D000236:Adenoma / Q000175:diagnosis / Q000276:immunology / Q000517:prevention & control; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D002277:Carcinoma / Q000175:diagnosis / Q000276:immunology / Q000517:prevention & control; D002681:China; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000276:immunology / Q000517:prevention & control*; D005260:Female; D006454:Hemoglobins / Q000276:immunology*; D006801:Humans; D007120:Immunochemistry; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D009780:Occult Blood; D012680:Sensitivity and Specificity
D006454:Hemoglobins