Evaluation of the performance of the devel-a-tab card and cassette system for bowel screening Wales
Cardiff Metropolitan University
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Introduction: The purpose of this study is to evaluate the performance of the DEVEL-A-TAB card and cassette system for Bowel Screening Wales. The use of the kit has been validated for use in screening 7, 15 but there is little information about some of the aspects of the procedure. Methods: Qualitative and quantitative FIT analysis were carried out to compare the parallel determination of positivity and Haemoglobin (Hb) concentration, also to identify limits for sample loading, select the appropriate elution time and determine whether 'barely positive' results should be counted as positive or negative. Results: The comparison of the FIT results with Hb concentration showed a statistically significant difference between positive and negative results (P<0.001). The median Hb concentration for the negative FlTs was 7ng/ml and for the positive FITS was 90ng/ml There was no statistically significant difference between the weak positive FIT with Hb concentration compared with the negative and positive FIT Hb concentrations. Investigation of elution time demonstrated a significant difference between each of the Hb increments between 10-40ng/ml over time (P=0.001). The expected threshold detection limit of 50ng/ml was positive at 15 minutes. All other Hb concentration variables were negative at all time points except for 40ng/ml at 60 minutes mixing time in which a 'bare'positive line rras observed. All negative FIT Hb concenhations were less than the 50ng/ml detection limit. Hb concentration at 50ng/ml or greater produced a positive result within 15 minutes. Conclusions: The study showed significance to weak positives FlTs and elution times; however colonoscopy findings would be beneficial to establishing whether referral for colonoscopy was warranted. The study also suggested a link between elution times and positivity. Sample loading could not be linked to positivity.
BSc (Hons) Biomedical Science
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