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.
Wong
Wai Man
WM
Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
Lam
Shiu Kum
SK
Cheung
Kwan Lok
KL
Tong
Teresa Sze Man
TS
Rozen
Paul
P
Young
Graeme P
GP
Chu
Kin Wah
KW
Ho
Judy
J
Law
Wai Lun
WL
Tung
Hiu Ming
HM
Choi
Hok Kwok
HK
Lee
Yee Man
YM
Lai
Kam Chuen
KC
Hu
Wayne H C
WH
Chan
Chi Kuen
CK
Yuen
Man Fung
MF
Wong
Benjamin Chun-Yu
BC
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