The quantaflashTM chemiluminescent immunoassays for coeliac disease show excellent analytical and clinical performance characteristics

• Published in: Pathology 2012, Vol.44, p.S71-S71
• Main Authors: Martis, Peter, Carrion, Priscilla, Li, Kitty, Burlingame, Rufus W., Lakos, Gabriella
• Format: Article
• Language: English
• ISSN: 0031-3025; 1465-3931
• DOI: 10.1016/S0031-3025(16)32784-2

Evaluate the analytical and clinical performances of four new chemiluminescent immunoassays developed for the random-access, automated BIO-FLASH® instrument for the diagnosis of coeliac disease (CD): IgA and IgG anti-human tissue transglutaminase (h-tTG) and anti-deamidated gliadin peptide (DGP). The precision, limits of detection and linearity were determined following Clinical Laboratory and Standards Institute (CLSI) guidelines. Clinical sensitivities and specificities were determined using more than 700 subjects consisting of CD patients, healthy subjects, and patients with other diseases. The QUANTA Flash assays have larger dynamic ranges than ELISAs. The entire reportable range shows linearity for all four antibodies. The within-run, between-run and total % CVs in all four CD assays were less than 12.2%. The clinical sensitivities were 93%, 50%, 68% and 81% for h-tTG IgA, h-tTG IgG, DGP IgA and DGP IgG, respectively. The clinical specificities ranged from 98.0% to 99.6%. All tests have high diagnostic efficiency, characterised by areas under the curve values of 0.99, 0.93, 0.92, and 0.93 for h-tTG IgA, h-tTG IgG, DGP IgA and DGP IgG, respectively. The new assays show excellent analytical performance characteristics. Their high clinical sensitivity and specificity make these tests invaluable for the diagnosis and management of coeliac disease patients.