Screening and monitoring coeliac disease: multicentre trial of a new serum antibody test kit.
A multicentre trial was conducted to evaluate a new test for anti-gliadin antibodies (AGA) in serum (Coeliac Screening Kit, CSK, Medical Innovations Limited, Artarmon, NSW, Australia). The test showed excellent reproducibility for both anti-gliadin IgA and IgG detection. The average intraassay coefficient of variation (CV) was 3.0% for IgA and 2.4% for IgG (n = 6), while the average interassay CV was 6.4% for IgA and 4.3% for IgG (n = 3). By defining a positive test as both IgA and IgG elevated, a sensitivity of 93% in untreated coeliacs (n = 75) was observed. The corresponding specificities in healthy adults (n = 130) and healthy children (n = 77) were > 99% and 100% respectively, while in patients with other gastrointestinal disorders (disease controls) the specificity was 94% (n = 129). The test was also useful in monitoring patients, with anti-gliadin IgA and IgG falling for up to a year after commencing a gluten-free diet (GFD) (12 adults). In some patients however, antibody levels did not reach the normal cutpoint after many months on a GFD, which may reflect the patients' poor adherence to their gluten free diet. The test was superior to the Pharmacia anti-gliadin ELISA, and should be useful as an aid to the diagnosis of coeliac disease, as well as in the follow-up of treated patients.
Dept. Obstetrics & Gynaecology, University of Queensland, Brisbane, Australia.
P L
PL
Devine
G W
GW
Birrell
J P
JP
Golder
M N
MN
Marsh
S
S
Morgan
G
G
Chang
D
D
Gillis
P
P
Hobson
P
P
Robertson
R
R
Whybin
D000328:Adult; D000906:Antibodies / Q000097:blood*; D002446:Celiac Disease / Q000175:diagnosis* / Q000178:diet therapy / Q000276:immunology; D002648:Child; D004797:Enzyme-Linked Immunosorbent Assay / Q000706:statistics & numerical data; D005903:Gliadin / Q000276:immunology*; D005983:Glutens / Q000008:administration & dosage; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D011933:Reagent Kits, Diagnostic / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D000906:Antibodies; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D011933:Reagent Kits, Diagnostic; D005983:Glutens; D005903:Gliadin