Monoclonal versus Polyclonal ELISA for Assessment of Fecal Elastase Concentration: Pitfalls of a New Assay

Schneider, A; Funk, Benjamin; Caspary, W. F.; Stein, Jürgen M.

doi:10.1373/clinchem.2004.046888

Cited by 26 publications

(19 citation statements)

References 8 publications

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“…Laboratory factors also play a role; for example, a fecal elastase test should be performed on a solid stool sample to avoid falsely positive results. (123) Serum amylase and lipase measurement should not be entirely discounted as a potentially useful indirect test of pancreatic function especially if they have a low value. (124–127)…”

Section: Methodsmentioning

confidence: 99%

American Pancreatic Association Practice Guidelines in Chronic Pancreatitis

Conwell¹,

Lee²,

Yadav³

et al. 2014

Pancreas

380

281

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The diagnosis of chronic pancreatitis remains challenging in early stages of the disease. This report defines the diagnostic criteria useful in the assessment of patients with suspected and established chronic pancreatitis. All current diagnostic procedures are reviewed and evidence based statements are provided about their utility and limitations. Diagnostic criteria for chronic pancreatitis are classified as definitive, probable or insufficient evidence. A diagnostic (STEP-wise; S-survey, T-tomography, E-endoscopy and P-pancreas function testing) algorithm is proposed that proceeds from a non-invasive to a more invasive approach. This algorithm maximizes specificity (low false positive rate) in subjects with chronic abdominal pain and equivocal imaging changes. Futhermore, a nomenclature is suggested to further characterize patients with established chronic pancreatitis based on TIGAR-O (T-toxic, I-idiopathic, G-genetic, A- autoimmune, R-recurrent and O-obstructive) etiology, gland morphology (Cambridge criteria) and physiologic state (exocrine, endocrine function) for uniformity across future multi-center research collaborations. This guideline will serve as a baseline manuscript that will be modified as new evidence becomes available and our knowledge of chronic pancreatitis improves.

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Section: Methodsmentioning

confidence: 99%

American Pancreatic Association Practice Guidelines in Chronic Pancreatitis

Conwell¹,

Lee²,

Yadav³

et al. 2014

Pancreas

380

281

View full text Add to dashboard Cite

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“…The monoclonal FE-1 assay has been confirmed to have good sensitivity and specificity for moderate and severe PEI in comparison with direct function tests, as well as with magnetic resonance cholangiopancreatography (MRCP) combined with diffusion-weighted magnetic resonance imaging (MRI) and endoscopic retrograde cholangiopancreatography (ERCP), which was long regarded as the gold standard of pancreatic imaging for CP [23][24][25][26][27]. More recently, a polyclonal FE-1 assay has been developed using two different polyclonal antisera to human pancreatic elastase, which recognize different antigenic epitopes [28]. It should be underlined that concentrations of FE-1 obtained with the polyclonal test tend to be higher than those obtained with the monoclonal test [29,30].…”

Section: The Fecal Elastase-1 Testmentioning

confidence: 99%

“…This should be taken into account when specifying normal values with the polyclonal test. Both the monoclonal and polyclonal assays are widely used in clinical practice, with a number of studies directly comparing the two tests [28,29,31]; however, a direct comparison of the two tests in patients with PEI and against an appropriate reference standard has yet to be performed. Recently, a new rapid FE-1 test has been developed that allows for results to be obtained within minutes.…”

Section: The Fecal Elastase-1 Testmentioning

confidence: 99%

Potential for Screening for Pancreatic Exocrine Insufficiency Using the Fecal Elastase-1 Test

et al. 2017

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The early diagnosis of pancreatic exocrine insufficiency (PEI) is hindered because many of the functional diagnostic techniques used are expensive and require specialized facilities, which prevent their widespread availability. We have reviewed current evidence in order to compare the utility of these functional diagnostic techniques with the fecal elastase-1 (FE-1) test in the following three scenarios: screening for PEI in patients presenting with symptoms suggestive of pancreatic disease, such as abdominal pain or diarrhea; determining the presence of PEI in patients with an established diagnosis of pancreatic disease, such as chronic pancreatitis or cystic fibrosis; determining exocrine status in disorders not commonly tested for PEI, but which have a known association with this disorder. Evidence suggests the FE-1 test is reliable for the evaluation of pancreatic function in many pancreatic and non-pancreatic disorders. It is non-invasive, is less time-consuming, and is unaffected by pancreatic enzyme replacement therapy. Although it cannot be considered the gold-standard method for the functional diagnosis of PEI, the advantages of the FE-1 test make it a very appropriate test for screening patients who may be at risk of this disorder.

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“…The commercially available ELISA kit uses two specific monoclonal antibodies against human elastase 1 to apply on a spot fecal sample [18, 19]. Immunoassay for FE-1 is relatively inexpensive, requires < 1 gm of stool and is covered by most commercial insurance carriers [8].…”

Section: Introductionmentioning

confidence: 99%

Diagnostic Performance of Measurement of Fecal Elastase-1 in Detection of Exocrine Pancreatic Insufficiency: Systematic Review and Meta-analysis

Vanga

Tansel

Sidiq

et al. 2018

Clinical Gastroenterology and Hepatology

150

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In a systematic review and meta-analysis of studies that compared fecal level of elastase-1 for detection of EPI, we found that normal level of elastase-1 (above 200 mcg/g) can rule out EPI in patients with a low probability of this disorder (such as those with irritable bowel syndrome with diarrhea). However, in these patients, an abnormal level of elastase-1 (below 200 mcg/g) has a high false-positive rate.

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Monoclonal versus Polyclonal ELISA for Assessment of Fecal Elastase Concentration: Pitfalls of a New Assay

Cited by 26 publications

References 8 publications

American Pancreatic Association Practice Guidelines in Chronic Pancreatitis

American Pancreatic Association Practice Guidelines in Chronic Pancreatitis

Potential for Screening for Pancreatic Exocrine Insufficiency Using the Fecal Elastase-1 Test

Diagnostic Performance of Measurement of Fecal Elastase-1 in Detection of Exocrine Pancreatic Insufficiency: Systematic Review and Meta-analysis

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