Test code: 3213
Effective update from 18/01/2019
The methodology employed to mesure faecal calprotectin will change to an automated chemiluminescent immunoassay (CLIA) from January 18th 2019. Although the same cut-off value (50 µg/g of faeces) is maintained, it should be taken into account that quantitatively significant variations may occur in elevated results. High values obtained by chemiluninescence method may be lower than the obtained by Enzyme Immunoassay.
It has been proven that both assays correctly classify the patients. Negative results of both assays correspond to the clinical group of asymptomatic patients, in remission or other diseases, and the positive results correspond to the group of patients with active inflammatory bowel disease.
Different studies have been published comparing new methods that some manufacturers have presented. These studies present the possibility of adding a stratification in the values of normality if the ROC curves of sensitivity and specificity are applied. According to the new method (Chemiluminescence), the article by Cin Chem Lab Med 2017 of M. Oyaert, et al., indicates that applying a sensitivity of 100% and a specificity of 95% patients could be stratified according to a multiple interval cut-off. That allows the clinical classification of patients in:
Results <50 µg/g: Not indicative of inflammation of the intestinal tract.
Results between 50-110 µg/g of feces: mild intestinal disorder and/or other pathologies (such as inflammation caused by NSAIDs, diverticulitis, etc) should be excluded.
Results >110 µg/g: Positive result of intestinal inflammation. Complete diagnostic study / review therapy.
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NEGATIVE : < to 50 mg/Kg Feces UNDETERMINED : 50 - 200 mg/Kg Feces INTESTINAL CHRONIC INF. DIS.: 200 - 20.000 mg/Kg Feces Methodology: Enzyme Immunoassay Delivery term: 5 days | Results less than 50 µg/g: Not indicative of inflammation of the intestinal tract. Results between 50-110 µg/g of feces: mild intestinal disorder and/or other pathologies (such as inflammation caused by NSAIDs, diverticulitis, etc) should be excluded. Results greater than 110 µg/g: Positive result of intestinal inflammation. Complete diagnostic study/review therapy. Methodology: Chemiluminescence Delivery term: 3 days |
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