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Variability of anti-human transglutaminase testing in celiac disease across Mediterranean countries
Andrea Smarrazzo1, Giuseppe Magazzù1, Mongi Ben-Hariz1
1Andrea Smarrazzo, Pio Stellato, Carmela Arcidiaco, Luigi Greco, Department of Translational Medical Sciences, School of Medicine, Section of Pediatrics, University of Naples "Federico II", 80131 Naples, Italy.
Aim:
To verify the precision and accuracy of transglutaminase antibodies (TGA) assays across Mediterranean countries.
Methods:
This study involved 8 referral centres for celiac disease (CD) in 7 Mediterranean countries. A central laboratory prepared 8 kits of 7 blinded and randomized serum samples, with a titrated amount of Human TGA IgA. Each sample was analysed three times on three different days, with each centre running a total of 21 tests. The results were included in a blindly coded report form, which was sent to the coordinator centre. The coordinator estimated the mean coefficient of Variation (CoVar = σ/μ), the mean accuracy (Accur = Vobserved - Vreal) and the mean percent variation (Var% = [(Vobserved - Vreal)/Vreal] × 100).
Results:
The analysis showed that 79.17% of the mean variation fell between -25% and +25% of the expected value, with the accuracy and precision progressively increasing with higher titres of TGA. From values 1.25 times greater than the normal cut-off, the measurements were highly reliable.
Conclusion:
TGA estimation is a crucial step for the diagnosis of CD; given its accuracy and precision, clinicians could be confident in establishing a diagnosis.
