Comparative evaluation of a new bedside faecal occult blood test in a prospective multicentre study.
BACKGROUND
Faecal occult blood testing is an established method of colorectal neoplasia screening. Guaiac-based tests are limited by poor patient compliance, low sensitivity, specificity and positive predictive value. Newer immunochemical-based tests, accurate but tedious, require a well-established laboratory set up. There is need for simpler immunochemical tests that can be performed at the out-patient clinic.


OBJECTIVE
To compare the performance characteristics of a new bedside immunological test strip device with a sensitive Guaiac-based and established immunochemical test for detection of faecal occult blood in patients undergoing colonoscopy.


METHODS
A total of 389 consecutive patients from four centres who were referred for colonoscopy also provided the stool samples for detection of occult blood without dietary restrictions. Stool tests performed were (i) Guaiac-based, (ii) immunochemical enzyme-linked immunosorbent assay and (iii) bedside immunochemical strip test.


RESULTS
At the optimal threshold level, the sensitivity and specificity of the beside immunochemical strip test for detection of significant colorectal neoplasia (adenomas >1.0 cm and carcinomas) were 60% and 95%, respectively.


CONCLUSIONS
This bedside immunochemical strip test proved to be a simple, convenient, non-cumbersome and accurate tool with similar performance characteristics for detection of any bleeding lesion including colorectal neoplasia when compared with an established immunochemical faecal occult blood test.
Hoepffner
N
N
Department of Medicine I, ZAFES, Centre of Internal Medicine, Johann Wolfgang Goethe University, Frankfurt/Main, Germany.
Shastri
Y M
YM
Hanisch
E
E
Rösch
W
W
Mössner
J
J
Caspary
W F
WF
Stein
J
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D005260:Female; D006138:Guaiac; D006801:Humans; D007202:Indicators and Reagents; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D009780:Occult Blood; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011934:Reagent Strips / Q000592:standards*; D012680:Sensitivity and Specificity
D007202:Indicators and Reagents; D011934:Reagent Strips; D006138:Guaiac