Analytical evaluation of eight qualitative FIT for haemoglobin products, for professional use in the UK.

Abstract

Objectives: Qualitative faecal immunochemical tests for haemoglobin (FIT), for triaging for colorectal cancer investigations, are available for professional use. The aim was to evaluate these lateral flow tests. No previous analytical evaluations have been published.

Methods: Analytical sensitivity (AS) was assessed using samples spanning manufacturers' quoted AS, concurrently with the quantitative OC-SENSOR PLEDIA, using Hb-spiked samples in manufacturers' buffer (n≥5; ≤9-99 ng Hb/mL buffer), Hb-spiked faeces (n=6; <2-34 µg Hb/g faeces) and natural faeces (n=17; <2-82 μg/g); concentrations for 50 %/100 % Hb-detected were compared with quoted AS. Compatibility with two external quality assessment schemes (EQAS) (n=9; 3-96 μg/g) and prozone compared with manufacturers limits (n=9; 2,500-10,000,000 ng/mL) were tested. Ease-of-use by five healthcare personnel was assessed.

Results: Seven products showed lower AS (ng/mL) than manufacturers quoted using Hb-spiked aqueous samples compared with OC-SENSOR, one was equivocal; six manufacturers quoted AS in µg/g, five showed lower AS using Hb-spiked faeces. Results were similar but less consistent for natural faeces. Result lines for low concentrations can be faint and open to interpretation. Results were consistent with manufacturers quoted prozone limits. Results were consistent for seven products for two EQAS. The ease-of-use was 68.5-85.6 %; products with lower scores could be improved with better instructions and sample bottles.

Conclusions: AS was lower for seven products (aqueous samples) and five products (aqueous/faecal samples) and prozone consistent with manufacturers expected concentrations, compared with OC-SENSOR. EQAS results were mostly consistent with expected results; products can be used by healthcare professionals, though some manufacturer improvements could be made.