Celiac disease screening by immunochromatographic visual assays: results of a multicenter study.
OBJECTIVE
To assay the efficiency for celiac disease (CD) screening of 2 immunochromatographic visual stick assays based on human recombinant tissue transglutaminase (tTG). One was the antitissue transglutaminase antibodies (AtTGA) stick for IgA/G antibodies to tTG detection, the other was the AtTGA/antigliadin antibodies (AGA) stick for IgA antibodies for tTG and/or gliadins.


METHODS
In a prospective multicenter study, 4 pediatric gastroenterology units from Spain and 2 from Latin America enrolled 72 control children with a normal small bowel mucosa and 113 untreated patients with CD with Marsh type 3 lesions.


RESULTS
Evaluation of results by the gastroenterologists and by 2 independent observers at the coordination center showed a remarkably low interobserver variability. For the AtTGA stick, sensitivity was 96.5% and specificity was 98.6%. The AtTGA/AGA stick displayed a sensitivity of 94.5% and a specificity of 98.6% for AtTGA and a sensitivity of 63.1% and a specificity of 95.2% for AGA. The highest efficiency and positive likelihood ratio was obtained for the AtTGA stick, higher than for IgA AtTGA by enzyme-linked immunosorbent assay. One additional advantage was that previous investigation of total serum IgA levels could be eluded. The IgA AtTGA/AGA stick, with an efficiency of 95.1%, compared with 89.2% when the combined results of the 2 enzyme-linked immunosorbent assays were considered, turned out to be an excellent diagnostic tool for infants with no IgA deficiency.


CONCLUSIONS
These 2 assays are extremely efficient for CD screening, by combining a high diagnostic accuracy with the simplicity and rapidity of visual methods.
Baviera
Luis Carlos Blesa
LC
Pediatric Gastroenterology Unit, La Fe Children's Hospital, Valencia, Spain. lcblesa@ono.com
Aliaga
Ester Donat
ED
Ortigosa
Luis
L
Litwin
Néstor
N
Peña-Quintana
Luis
L
Méndez
Virginia
V
González
Ma Victoria
MV
López-Manzanares
Javier Manzanares
JM
Méndez
Enrique
E
Koninckx
Carmen Ribes
CR
D000293:Adolescent; D000888:Antibodies, Anti-Idiotypic / Q000276:immunology; D015415:Biomarkers / Q000097:blood; D002446:Celiac Disease / Q000175:diagnosis* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D002845:Chromatography / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay; D005903:Gliadin / Q000097:blood / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007070:Immunoglobulin A / Q000097:blood / Q000276:immunology; D007074:Immunoglobulin G / Q000097:blood / Q000276:immunology; D007223:Infant; D007843:Latin America; D008403:Mass Screening / Q000379:methods*; D015588:Observer Variation; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013030:Spain; D011503:Transglutaminases / Q000097:blood / Q000276:immunology
D000888:Antibodies, Anti-Idiotypic; D015415:Biomarkers; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D005903:Gliadin; D011503:Transglutaminases