Comparison of the QuikRead go^® point-of-care faecal immunochemical test for haemoglobin with the FOB Gold Wide^® laboratory analyser to diagnose colorectal cancer in symptomatic patients

Abstract

Objectives Faecal immunochemical testing for haemoglobin (FIT) is used to triage patients for colonic investigations. Point-of-care (POC) FIT devices on the market have limited data for their diagnostic accuracy for colorectal cancer (CRC). Here, a POC FIT device is compared with a laboratory-based FIT system using patient collected samples from the urgent referral pathway for suspected CRC. Methods A prospective, observational cohort study. Patients collected two samples from the same stool. These were measured by POC QuikRead go® (Aidian Oy, Espoo, Finland) and laboratory-based FOB Gold Wide® (Sentinel Diagnostics, Italy). Faecal haemoglobin <10 μg haemoglobin/g of faeces was considered as negative. At this threshold, comparisons between the two systems were made by calculating percentage agreement and Cohen’s kappa coefficient. Proportion of negative results were compared with Chi squared testing. Sensitivities for CRC were calculated. Results A total of 629 included patients provided paired samples for FIT to compare the QuikRead go® and FOB Gold Wide®. The agreement around the negative threshold was 83.0% and Cohen’s kappa coefficient was 0.54. The QuikRead go® reported 440/629 (70.0% of samples) as negative compared to 523/629 (83.1%) for the FOB Gold Wide®, this difference was significant (p-value<0.001). Sensitivities for CRC detection by the QuikRead go® and FOB Gold Wide® were 92.9% (95% confidence interval (CI): 68.5–98.7%) and 100% (CI: 78.5–100%) respectively. Conclusions Both systems were accurate in their ability to detect CRC. Whilst good agreement around the negative threshold was identified, more patients would be triaged to further colonic investigation if using the QuikRead go®.

Faecal immunochemical testing (FIT) in patients with signs or symptoms of suspected colorectal cancer (CRC): a joint guideline from the Association of Coloproctology of Great Britain and Ireland (ACPGBI) and the British Society of Gastroenterology (BSG)

“…To date there are only two peer-reviewed publications that have directly compared results obtained on two different FIT analytical systems when patients have taken samples from the same bowel motion in a symptomatic pathway 75 101…”

“…In the second study 101 the QuikRead Go (QRG), a quantitative point of care FIT test which had previously undergone independent analytical evaluation 102 was compared with the FOB Gold wide method on the SENTiFIT laboratory analyser. Five hundred and fifty-three patients provided paired samples for both methods and underwent colonic investigations that were suitable to give definitive diagnostic outcomes.…”

Efficacy and accuracy of faecal sampling by a digital rectal examination for faecal immunochemical testing

“…The diagnostic accuracy of the QRG and its comparison to laboratory-based testing has previously been reported for this study. 9,10 A third sample was obtained via DRE and also analysed with the laboratory-based FOB Gold Wide ® to allow direct comparison with the sample collected by the patient.…”

Accuracy of a faecal immunochemical test in patients under colonoscopy surveillance of colorectal adenoma and cancer

“…This is a point-of-care quantitative immunochemical test device ( 5 ). All technicians involved received specific training for the study.…”