Faecal calprotectin is not necessarily required as a screen for significant bowel disease in primary care

Author(s):  
Matthew Malcolm Andrew Waite ◽  
Louise Langmead ◽  
Ruth M Ayling

Objective NICE recommends measurement of faecal haemoglobin (f-Hb) using faecal immunochemical test (FIT) when colorectal cancer is suspected and calprotectin (f-Cal) in the context of inflammatory bowel disease, though neither is disease specific. During the COVID-19 pandemic, f-Hb has been a requirement prior to referral for endoscopy in England; f-Cal is often performed simultaneously. The aim of this study was to investigate test performance of both tests for significant bowel disease in those patients referred. Design All adult patients with simultaneous measurements of f-Hb and f-Cal between April 2019 and September 2020 were included. For those referred, outcomes were determined from clinical records. Results 650 patients with simultaneous samples for f-Hb an f-Cal were managed in Primary Care; 319 patients were referred to hospital; SBD was found in 32 (10.0%) (CRC 5, high risk adenomas 5, IBD 22). At a cut-off of 10 μg/g for f-Hb and 200 μg/g for f-Cal, the sensitivity, specificity and negative predictive value for diagnosis of SBD were 84.4%, 58.2% and 96.7% and 68.8%, 89.6% and 95.7%, respectively. Performance of both tests would have enabled diagnosis of two more cases of significant, but non-malignant, bowel disease but required over 4% more referrals for investigation. Conclusion Use of FIT has become established to assist prioritisation of patients for referral from Primary Care. Whilst introduced specifically for CRC, FIT performs well as a rule out for IBD in Primary Care and the use of f-Cal is not required.

Author(s):  
Kirn Sandhu ◽  
Sandhia Naik ◽  
Ruth M Ayling

Background Faecal calprotectin has been widely used as a non-invasive marker of intestinal inflammation in children. Measurement of faecal haemoglobin using faecal immunochemical test is well established in adults for detection of colorectal cancer. In adults, faecal haemoglobin has been recommended as a reliable tool to aid identification of those at low risk of significant bowel disease and has also been used in inflammatory bowel disease to assess mucosal healing. Aims We aimed to evaluate the performance of faecal haemoglobin in the paediatric population and compare it with faecal calprotectin. Methods Children being assessed in the paediatric gastroenterology clinic for bowel symptoms had a sample sent for both faecal calprotectin and faecal haemoglobin. Samples were collected over a 10-month period from November 2018 to September 2019. Faecal haemoglobin was measured using an OC-Sensor. Faecal calprotectin was measured using Liason®Calprotectin. Results One hundred forty three samples were returned for faecal haemoglobin and in 107 a paired faecal calprotectin was also available. Faecal haemoglobin correlated with faecal calprotectin, Spearman’s rank coefficient 0.656 ( P < 0.0001). There were 35 patients with faecal haemoglobin >20 μg/g and in 32 of these patients faecal calprotectin was >200 μg/g; 74 patients with faecal haemoglobin and 38 patients with faecal calprotectin underwent colonoscopy. Patients with normal histology had faecal haemoglobin <4 μg/g; faecal haemoglobin >20 µg/g was associated with signification inflammation Conclusion Our study is the first to compare faecal haemoglobin and faecal calprotectin in a paediatric population. Results suggest that faecal haemoglobin correlates with faecal calprotectin and, as in adults, may be useful to rule out significant bowel disease. A faecal haemoglobin >20 μg/g was consistent with significant histological inflammation.


BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e027428 ◽  
Author(s):  
Karoline Freeman ◽  
Brian H Willis ◽  
Hannah Fraser ◽  
Sian Taylor-Phillips ◽  
Aileen Clarke

ObjectiveTest accuracy of faecal calprotectin (FC) testing in primary care is inconclusive. We aimed to assess the test accuracy of FC testing in primary care and compare it to secondary care estimates for the detection of inflammatory bowel disease (IBD).MethodsSystematic review and meta-analysis of test accuracy using a bivariate random effects model. We searched MEDLINE, EMBASE, Cochrane Library and Web of Science until 31 May 2017 and included studies from auto alerts up until 31 January 2018. Eligible studies measured FC levels in stool samples to detect IBD in adult patients with chronic (at least 6–8 weeks) abdominal symptoms in primary or secondary care. Risk of bias and applicability were assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 criteria. We followed the protocol registered as PROSPERO CRD 42012003287.Results38 out of 2168 studies were eligible including five from primary care. Comparison of test accuracy by setting was precluded by extensive heterogeneity. Overall, summary estimates of sensitivity and specificity were not recorded. At a threshold of 50 µg/g, sensitivity from separate meta-analysis of four assay types ranged from 0.85 (95% CI 0.75 to 0.92) to 0.94 (95% CI 0.75 to 0.90) and specificity from 0.67 (95% CI 0.56 to 0.76) to 0.88 (95% CI 0.77 to 0.94). Across three different definitions of disease, sensitivity ranged from 0.80 (95% CI 0.76 to 0.84) to 0.97 (95% CI 0.91 to 0.99) and specificity from 0.67 (95% CI 0.58 to 0.75) to 0.76 (95% CI 0.66 to 0.84). Sensitivity appears to be lower in primary care and is further reduced at a revised threshold of 100 µg/g.ConclusionsConclusive estimates of sensitivity and specificity of FC testing in primary care for the detection of IBD are still missing. There is insufficient evidence in the published literature to support the decision to introduce FC testing in primary care. Studies evaluating FC testing in an appropriate primary care setting are needed.


Author(s):  
Jayne Digby ◽  
Judith A Strachan ◽  
Rebecca McCann ◽  
Robert JC Steele ◽  
Callum G Fraser ◽  
...  

Background Current guidelines document persistent rectal bleeding as an alarm symptom in patients presenting to primary care. We studied whether a faecal immunochemical test could assist in their assessment. Methods From December 2015, faecal immunochemical tests were routinely available to primary care when assessing patients with new-onset bowel symptoms: general practitioners were encouraged to include faecal haemoglobin concentration (f-Hb) within any referral to secondary care. Results with f-Hb ≥10  μg Hb/g faeces were defined as positive. The incidence of significant bowel disease (SBD: colorectal cancer [CRC], higher-risk adenoma [HRA: any ≥1 cm, or three or more] and inflammatory bowel disease [IBD]) at subsequent colonoscopy, referred symptoms and f-Hb were recorded. Results Of 1447 patients with a faecal immunochemical test result and colonoscopy outcome, SBD was diagnosed in 296 patients (20.5%; 95 with CRC, 133 with HRA, and 68 with IBD). Four hundred and sixty-two patients (31.9%) reported rectal bleeding: 294 had f-Hb ≥10  μg Hb/g faeces. At colonoscopy, 105/294 had SBD versus 14/168 with rectal bleeding and f-Hb <10  μg Hb/g faeces ( P < 0.0001), comprising one case of CRC (0.6%), 12 HRA (7.1%) and one new case of IBD (0.6%); further, the single cancer and 8 of the 12 HRA were located in the descending colon. Conclusion Patients with rectal bleeding and f-Hb <10  μg Hb/g faeces are unlikely to have SBD and could be investigated by sigmoidoscopy alone. Using the faecal immunochemical test to guide investigation of patients with rectal bleeding is a rational and practical way forward.


2017 ◽  
Vol 71 (4) ◽  
pp. 316-322 ◽  
Author(s):  
Samantha Conroy ◽  
Melissa F Hale ◽  
Simon S Cross ◽  
Kirsty Swallow ◽  
Reena H Sidhu ◽  
...  

BackgroundFaecal calprotectin (FC) measurement distinguishes patients with inflammatory bowel disease (IBD) from those with irritable bowel syndrome but evidence of its performance in primary care is limited.AimsTo assess the yield of IBD from FC testing in primary care.MethodsRetrospective review of hospital records to assess the outcome following FC testing in primary care. Investigations for all patients undergoing FC testing in a single laboratory for 6 months from 1 October 2013 to 28 February 2014 were reviewed.Results410 patients (162 male; median age 42; range 16–91) were included. FC>50 µg/g was considered positive (FC+). 148/410 (36.1%; median age 44 (17–91)) were FC+ (median FC 116.5 µg/g (51–1770)). 122/148 FC-positive patients (82.4%) underwent further investigation. 97 (65.5%) underwent lower gastrointestinal endoscopy (LGIE), of which 7 (7.2%) had IBD. 49/262 (18.7%) FC-negative (FC−) patients (FC ≤50 µg/g) (median age 47 (19–76)) also underwent LGIE, of whom 3 (6.1%) had IBD.IBD was diagnosed in 11/410 (2.7%; 4 ulcerative colitis, 3 Crohn’s disease, 4 microscopic colitis). 8/11 were FC+ (range 67–1170) and 3 FC−. At a 50 µg/g threshold, sensitivity for detecting IBD was 72.7%, specificity 64.9%, positive predictive value (PPV) 5.41% and negative predictive value 98.9%. Increasing the threshold to 100 µg/g reduced the sensitivity of the test for detecting IBD to 54.6%.ConclusionsFC testing in primary care has low sensitivity and specificity with poor PPV for diagnosing IBD. Its use needs to be directed to those with a higher pretest probability of disease. Local services and laboratories should advise general practitioners accordingly.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S240-S240
Author(s):  
M S ISMAIL ◽  
G Murphy ◽  
C Kelly ◽  
F O’Riordan ◽  
S Semenov ◽  
...  

Abstract Background Mucosal healing (MH) is one of the goals of IBD therapy. Currently, the only way to assess MH is by colonoscopy. Faecal calprotectin (FC) and faecal immunochemical test (FIT) which detect colonic inflammation and bleeding might be useful adjuncts. Aim To assess FIT and FC as surrogate markers of MH. Methods Following ethical approval, patients undergoing routine colonoscopy were prospectively recruited. Demographics and colonoscopy findings were documented. A FIT and FC were collected prior to colonoscopy. FIT and FC were processed in our laboratory and reported as µg/g of stool. MH was defined no visible activity on colonoscopy. Results Of 105 colonoscopies, FC and FIT results were available in 99 and 88 patients. Mean age 48.8, 52% (55) males, 34% (36) UC, 60% (63) Crohn’s, 0.05% (6) IBDU. In all, MH occurred in 12%, (n = 12). In MH, the mean FIT and FC were 1142 and 353, while in active cases were 750 and 819. Only FC was significantly lower in MH cases (353 vs. 819, p = 0.05). Using standard cut-offs of &gt;50; sensitivity, specificity, PPV and NPV for MH for FIT was poor; 59%, 33%, 89%, 9% and for FC was better at 74%, 73%, 91%, 44%. The overall correlation between the biomarkers was weak r = 0.2, p &lt; 0.01. FC ROC analysis gave a specificity and sensitivity of 75% and 67% for a cut-off of &lt;64µg/g, AUC = 0.65. Conclusion MH was uncommon (12%) reflecting our clinical practice. FIT was a poor predictor of MH. FC might be a useful marker albeit ongoing research is needed to set an appropriate cut-off.


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