Evaluation of a New Technique for iFOBT Utilising a New Sample Collection Device with Increased Buffer Stability.

Abstract

The aims of the present study were: (i) Evaluate specificity and sensitivity of Hb Smart enzyme-linked immunosorbent assay (ELISA) (ScheBo Biotech) compared to colonoscopy results and (ii) assess stability of a new sample collection device containing a newly formulated buffer to extract haemoglobin using buffer and stool samples spiked with defined concentrations of haemoglobin. Stool samples were quantified with the ELISA method. The stability of haemoglobin in the extraction buffer and in native stool samples, respectively, was determined daily by ELISA during storage for 5 days at 4°C and at room temperature after addition of haemoglobin. Haemoglobin ELISA had a sensitivity of 78.4% for detection of CRC with a specificity of 98%. Haemoglobin extracted in corresponding extraction buffer demonstrated stability throughout storage for 5 days at 4°C and at room temperature. Hb Smart represents a very promising tool for large-scale screening of CRC with regard to sample handling, stability and analysis of haemoglobin in faeces.