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What Is the Faecal Calprotectin Test?

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What Is the Faecal Calprotectin Test? DTB | What is the faecal calprotectin test? DTB CME/CPD* BNF 4.6 What is the faecal calprotectin test? Calprotectin is a protein released by white blood cells involved in inflammation of the bowel.1 It can be detected in faeces using laboratory or point of care tests. Although an elevated calprotectin level indicates inflammation in the bowel, it cannot identify the cause.1 Faecal calprotectin testing is mainly used in distinguishing between ‘functional’ disorders such as irritable bowel syndrome and ‘organic’ disorders, such as inflammatory bowel disease, a group of conditions including Crohn’s disease and ulcerative colitis that require referral to specialist services. Here we explain the role of faecal calprotectin testing in adults in primary care. About faecal calprotectin and testing Cut-off levels In patients with intestinal inflammation, neutrophils recruited to the site Studies that compared ELISA tests with endoscopy as the reference of inflammation release calprotectin into the stool; this binds to calcium standard for distinguishing irritable bowel syndrome (IBS) and to form a stable compound which is not broken down in the intestines.1 inflammatory bowel disease (IBD) in adults found that the sensitivity of the test ranged from 83% to 100% at a cut-off of 50µg/g (the cut-off level recommended by manufacturers of the ELISA and most POCTs), but Sample collection specificity varied (51–100%) at lower cut-off levels (see Box 1).1 Some manufacturers suggest re-testing samples if results are between 30 and Faecal calprotectin measurements require a small sample of faeces which 70µg/g, as there is a ‘grey zone’ between positive and negative tests due can be obtained relatively easily using universal containers with a spoon to imprecision around the cut-off value of 50µg/g.1 attached to the interior of the screw cap, or other commercially available devices. Sampling of the first bowel motion of the day, when the patient is most symptomatic, is recommended and could increase the diagnostic Box 1: Definitionsii yield for distal colitis (proctitis).2 Information for patients and guidance on i stool sampling can be found on the nhs.uk website. Sensitivity: ability to correctly identify people with the disease Specificity: ability to correctly identify people who do not have Faecal calprotectin tests the disease Tests to detect or measure the amount of calprotectin in faeces include Positive predictive value: probability that the person has the disease laboratory tests (e.g. enzyme-linked immunosorbent assay [ELISA]) or if the test result is positive lateral flow chromatographic immunoassay point of care tests (POCTs). In Negative predictive value: probability that the person does not have the ELISA test, an antibody to calprotectin is attached to a microtitre plate. the disease if the test is negative When the sample is added, any calprotectin present attaches onto the antibody on the plate. The plate is exposed to an enzyme, and the Diagnostic test accuracy: overall proportion of correct results amount of enzyme product (detected by colorimetry or fluorimetry) reflects the amount of calprotectin present in the sample.1,3,4 In a lateral flow chromatographic immunoassay POCT, the sample is diluted and Detecting inflammation with calprotectin added to the sample port of a test cassette or device. The sample flows across a pad containing conjugate particles that bind to the target In a meta-analysis of 30 studies involving a total of 5,983 patients, molecule (calprotectin) and the target/conjugate complex then binds to comparing faecal calprotectin levels against histological diagnosis, immobilised antibodies and produces a visible line. For some POCT patients with IBD had a significantly higher calprotectin level than systems, an optical reader is needed to provide a quantitative readout of patients with normal findings (weighted mean difference 219µg/g, 95% calprotectin level. With other POCT systems a semi-quantitative estimate CI 174 to 264, p<0.001), giving a sensitivity of 95% and specificity of 91% 5 of calprotectin level is read directly from the test device. for the diagnosis of IBD. ▶ ELISA methods are relatively time consuming and expensive and require laboratory facilities, while some POCTs can provide faster results, within about 30 minutes.1,3,4 However, some POCTs may require a degree of * DTB CME/CPD sample preparation (e.g. centrifugation). The results are usually presented A CME/CPD module based on this article is available for completion online via BMJ as µg calprotectin per g of faeces (or mg/kg). Learning (learning.bmj.com) by subscribers to the online version of DTB. If prompted, subscribers must sign into DTB with their username and password. All users must The current evidence base does not suggest any preference for any test also complete a one-time registration on BMJ Learning and subsequently log in (with over the others on diagnostic grounds; relative cost and availability may a BMJ Learning username and password) on every visit. The answers to the multiple be more important in the choice of test.1 choice questions will be freely available on dtb.bmj.com on publication of the next issue of DTB. i See “How should I collect and store a stool (faeces) sample?” http://www.nhs.uk/chq/ ii Please see Understanding statistical terms 4: diagnostic tests (DTB 2009; 47: 71-2) for Pages/how-should-i-collect-and-store-a-stool-faeces-sample.aspx?CategoryID=69. further information on sensitivity and specificity. 102 | DTB | Vol 52 | No 9 | September 2014 dtb.bmj.com DTB | What is the faecal calprotectin test? However, an important issue about faecal calprotectin testing and rather than secondary care relate to the different prevalence of disease interpretation is that it can detect inflammation but is not disease- in the two patient populations and the objectives of the test.2,12 specific. Elevated levels may be associated with conditions other than The emphasis in specialist care is usually on ‘ruling in’: increasing the IBD (e.g. symptomatic diverticular disease),6 certain medications probability of IBD to carry out more expensive, time consuming and (e.g. NSAIDs, proton pump inhibitors),7,8 or an artefact of within-patient invasive procedures, establish a firm diagnosis and start appropriate variation. It has been recommended to stop NSAID use several weeks treatment, so a diagnostic test with a high positive likelihood ratio is before measuring faecal calprotectin.7 Some authors have suggested preferred.12 In primary care, where the prevalence of IBD is low, the stopping alcohol for 1 week prior to testing.9 In patients presenting for emphasis is on ‘ruling out’: lowering the probability of the target the first time in primary care who have an initial faecal calprotectin disease to provide reassurance, or to adopt a ‘watchful waiting’ level in the range 50–150µg/g, a repeat sample may be warranted to strategy.12 In these instances, tests with a low negative likelihood ratio reduce the false-positive rate due to within-patient variation.7 are preferred.12 Primary care healthcare professionals will be looking for parameters such as sensitivity for IBD and negative predictive value to provide a basis for a decision not to refer.1 Differentiating IBS and IBD A retrospective study has been published based on consecutively The majority of younger adult patients (<45 years) seen with lower collected faecal calprotectin data from 962 patients aged 18–45 years abdominal symptoms (e.g. change in bowel habit, abdominal pain, presenting to their GP with persistent gastrointestinal symptoms, bloating for over 1 month and no red-flag symptoms) in general excluding patients older than 45 years with alteration in bowel habit or practice have IBS.1 Red-flag symptoms (e.g. anaemia, rectal bleeding, those with alarm symptoms (weight loss, rectal bleeding and unexplained weight loss, abdominal masses, change in bowel habit in anaemia).2 In the study, 686 (71%) patients had a negative test patients over 60 years old, family history of bowel cancer) are (<50µg/g) and 276 (29%) had a positive test; 28% (77/276) of the indications for rapid referral.1 There are no biological markers to define patients testing positive and 3% (17/686) of those testing negative had IBS, so a consensus definition and criteria were developed, the Rome a diagnosis of organic disease (e.g. ulcerative colitis, Crohn’s disease, criteria (see Box 2).10 other colitis or infective diarrhoea, coeliac disease, NSAID-induced or alcohol-related problems, Meckel’s diverticulum or rectal adenocarcinoma) on further investigation.2 At 50µg/g, the sensitivity of Box 2: The Rome III Diagnostic Criteria* for the test for organic disease was 82% (95% CI 73% to 89%) and the irritable bowel syndrome11 specificity was 77% (95% CI 74% to 80%), with negative predictive value (NPV) and positive predictive value (PPV) of 98% and 28%, Recurrent abdominal pain or discomfort† at least 3 days/month in respectively. the last 3 months associated with two or more of the following: With the lower prevalence of disease in primary care, the cut-off value 1. Improvement with defecation that is used for the test may need to be higher than that used in secondary care, which may lead to missing organic pathology.2 An 2. Onset associated with a change in frequency of stool increase in cut-off to 150µg/g in the aforementioned study reduced the 3. Onset associated with a change in form (appearance) of stool NPV by 1% whilst increasing the PPV to 71%. This would have reduced * Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior the number of colonoscopies and flexible sigmoidoscopies by 10% to diagnosis. (potential endoscopic cost savings of £36,625 and specialist referral 2 †’Discomfort’ means an uncomfortable sensation not described as pain.
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    Medical Policy Fecal Calprotectin Testing Table of Contents • Policy: Commercial • Coding Information • Information Pertaining to All Policies • Policy: Medicare • Description • References • Authorization Information • Policy History Policy Number: 329 BCBSA Reference Number: 2.04.69 NCD/LCD: N/A Related Policies Fecal Analysis in the Diagnosis of Intestinal Dysbiosis, #556 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Medicare HMO BlueSM and Medicare PPO BlueSM Members Fecal calprotectin testing may be considered MEDICALLY NECESSARY for the evaluation of patients when the differential diagnosis is inflammatory bowel disease or noninflammatory bowel disease (including irritable bowel syndrome) for whom endoscopy with biopsy is being considered. Fecal calprotectin testing is considered INVESTIGATIONAL in the management of bowel disease, including the management of active inflammatory bowel disease and surveillance for relapse of disease in remission. Prior Authorization Information Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient. Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient. Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. Medicare HMO BlueSM Prior authorization is not required. Medicare PPO BlueSM Prior authorization is not required. 1 CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.
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