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Comparison of anti-transglutaminase ELISAs and an anti-endomysial antibody assay in the diagnosis of celiac disease: a prospective study.

Abstract

BACKGROUND

Most studies of anti-transglutaminase (anti-tTG) assays have considered preselected groups of patients. This study compared the sensitivity, specificity, and predictive value of an immunofluorescence method for anti-endomysial antibodies (EmAs) and two anti-tTG ELISAs, one using guinea pig tTG (gp-tTG) and the other human tTG (h-tTG) as antigen, in consecutive patients investigated for suspected celiac disease (CD).

METHODS

We studied 207 consecutive patients (99 men, 108 women; age range, 17-84 years) who underwent intestinal biopsy for suspected CD. Patients presented with one or more of the following: weight loss, anemia, chronic diarrhea, abdominal pain, dyspepsia, alternating bowel habits, constipation, pain in the joints, and dermatitis. At entry to the study, an intestinal biopsy was performed and a serum sample was taken for IgA EmAs, anti-gp-tTG, and anti-h-tTG.

RESULTS

Intestinal histology showed that 24 patients had partial or total villous atrophy; in these patients the diagnosis of CD was confirmed by follow-up. The remaining 183 patients had villous/crypt ratios that were within our laboratory's reference values and were considered controls. Serum EmAs, anti-gp-tTG, and anti-h-tTG were positive in all 24 CD patients; in the control group, none were positive for serum EmAs, but 15 of 183 (8.2%) were positive for anti-gp-tTG, and 6 of 183 (3.3%) were positive for anti-h-tTG. Sensitivity was 100% for all assays, whereas specificity was 100% for the EmA, 92% for the anti-gp-tTG, and 97% for the anti-h-tTG assay. The negative predictive value was 100% for all assays; the positive predictive value was 100% for the EmA, 80% [95% confidence interval (CI), 65-95%] for the anti-h-tTG (P = 0.03 vs EmA) and 60% (95% CI, 44-76%) for the anti-gp-tTG assay (P = 0.0002 vs EmA). Areas (95% CIs) under the ROC curves were 0.987 (0.97-1.0) for anti-h-tTG and 0.965 (0.94-0.99) for anti-gp-tTG. Most of the patients testing false positive for anti-tTG had Crohn disease or chronic liver disease.

CONCLUSIONS

Although both anti-tTG ELISAs showed optimum sensitivity, their lack of specificity yielded positive predictive values significantly lower than those for the EmA assay.

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  • Authors+Show Affiliations

    ,

    First and Second Divisions of Internal Medicine, University Hospital of Palermo, via Coffaro 25, 90127 Palermo, Italy. liwcar@tin.it

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    Source

    Clinical chemistry 48:9 2002 Sep pg 1546-50

    MeSH

    Adolescent
    Adult
    Aged
    Aged, 80 and over
    Animals
    Antibody Specificity
    Autoantibodies
    Celiac Disease
    Enzyme-Linked Immunosorbent Assay
    Esophagus
    Female
    Guinea Pigs
    Haplorhini
    Humans
    Immunoglobulin A
    Male
    Middle Aged
    Predictive Value of Tests
    Prospective Studies
    Transglutaminases

    Pub Type(s)

    Comparative Study
    Journal Article

    Language

    eng

    PubMed ID

    12194932

    Citation

    Carroccio, Antonio, et al. "Comparison of Anti-transglutaminase ELISAs and an Anti-endomysial Antibody Assay in the Diagnosis of Celiac Disease: a Prospective Study." Clinical Chemistry, vol. 48, no. 9, 2002, pp. 1546-50.
    Carroccio A, Vitale G, Di Prima L, et al. Comparison of anti-transglutaminase ELISAs and an anti-endomysial antibody assay in the diagnosis of celiac disease: a prospective study. Clin Chem. 2002;48(9):1546-50.
    Carroccio, A., Vitale, G., Di Prima, L., Chifari, N., Napoli, S., La Russa, C., ... Notarbartolo, A. (2002). Comparison of anti-transglutaminase ELISAs and an anti-endomysial antibody assay in the diagnosis of celiac disease: a prospective study. Clinical Chemistry, 48(9), pp. 1546-50.
    Carroccio A, et al. Comparison of Anti-transglutaminase ELISAs and an Anti-endomysial Antibody Assay in the Diagnosis of Celiac Disease: a Prospective Study. Clin Chem. 2002;48(9):1546-50. PubMed PMID: 12194932.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Comparison of anti-transglutaminase ELISAs and an anti-endomysial antibody assay in the diagnosis of celiac disease: a prospective study. AU - Carroccio,Antonio, AU - Vitale,Giustina, AU - Di Prima,Lidia, AU - Chifari,Nadia, AU - Napoli,Salvatore, AU - La Russa,Cristina, AU - Gulotta,Gaspare, AU - Averna,Maurizio R, AU - Montalto,Giuseppe, AU - Mansueto,Serafino, AU - Notarbartolo,Alberto, PY - 2002/8/27/pubmed PY - 2002/9/14/medline PY - 2002/8/27/entrez SP - 1546 EP - 50 JF - Clinical chemistry JO - Clin. Chem. VL - 48 IS - 9 N2 - BACKGROUND: Most studies of anti-transglutaminase (anti-tTG) assays have considered preselected groups of patients. This study compared the sensitivity, specificity, and predictive value of an immunofluorescence method for anti-endomysial antibodies (EmAs) and two anti-tTG ELISAs, one using guinea pig tTG (gp-tTG) and the other human tTG (h-tTG) as antigen, in consecutive patients investigated for suspected celiac disease (CD). METHODS: We studied 207 consecutive patients (99 men, 108 women; age range, 17-84 years) who underwent intestinal biopsy for suspected CD. Patients presented with one or more of the following: weight loss, anemia, chronic diarrhea, abdominal pain, dyspepsia, alternating bowel habits, constipation, pain in the joints, and dermatitis. At entry to the study, an intestinal biopsy was performed and a serum sample was taken for IgA EmAs, anti-gp-tTG, and anti-h-tTG. RESULTS: Intestinal histology showed that 24 patients had partial or total villous atrophy; in these patients the diagnosis of CD was confirmed by follow-up. The remaining 183 patients had villous/crypt ratios that were within our laboratory's reference values and were considered controls. Serum EmAs, anti-gp-tTG, and anti-h-tTG were positive in all 24 CD patients; in the control group, none were positive for serum EmAs, but 15 of 183 (8.2%) were positive for anti-gp-tTG, and 6 of 183 (3.3%) were positive for anti-h-tTG. Sensitivity was 100% for all assays, whereas specificity was 100% for the EmA, 92% for the anti-gp-tTG, and 97% for the anti-h-tTG assay. The negative predictive value was 100% for all assays; the positive predictive value was 100% for the EmA, 80% [95% confidence interval (CI), 65-95%] for the anti-h-tTG (P = 0.03 vs EmA) and 60% (95% CI, 44-76%) for the anti-gp-tTG assay (P = 0.0002 vs EmA). Areas (95% CIs) under the ROC curves were 0.987 (0.97-1.0) for anti-h-tTG and 0.965 (0.94-0.99) for anti-gp-tTG. Most of the patients testing false positive for anti-tTG had Crohn disease or chronic liver disease. CONCLUSIONS: Although both anti-tTG ELISAs showed optimum sensitivity, their lack of specificity yielded positive predictive values significantly lower than those for the EmA assay. SN - 0009-9147 UR - https://www.unboundmedicine.com/medline/citation/12194932/Comparison_of_anti_transglutaminase_ELISAs_and_an_anti_endomysial_antibody_assay_in_the_diagnosis_of_celiac_disease:_a_prospective_study_ L2 - http://www.clinchem.org/cgi/pmidlookup?view=long&pmid=12194932 DB - PRIME DP - Unbound Medicine ER -