World journal of gastroenterology · 2017
Variability of anti-human transglutaminase testing in celiac disease across Mediterranean countries.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеВалидационное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Smarrazzo Andrea, Magazzù Giuseppe, Ben-Hariz Mongi, Legarda Tamara Maria, Velmishi Virtut, Roma Elefhteria, Kansu Aydan, Mičetić-Turk Dušanka, Bravi Enzo, Stellato Pio, Arcidiaco Carmela, Greco Luigi
Аннотация
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.
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.