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 cen...
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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 Ig A.Each sample was analysed three times on three different days,with each centre running a total of 21tests.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(Co Var=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.
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