首页|Evaluation of the RSR 3 screen ICA (TM) and 2 screen ICA (TM) as screening assays for type 1 diabetes in Sweden
Evaluation of the RSR 3 screen ICA (TM) and 2 screen ICA (TM) as screening assays for type 1 diabetes in Sweden
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NSTL
Springer Nature
Aim The study aim was to evaluate the RSR 3 Screen ICA (TM) and 2 Screen ICA (TM) for detection of islet cell autoimmunity in healthy Swedish subjects and patients with newly diagnosed type 1 diabetes (T1D)。 Methods 3 Screen is designed for combined detection of autoantibodies to glutamic acid decarboxylase (GADA)， to the islet antigen IA-2 (IA-2A) and to zinc transporter 8 (ZnT8A)， while 2 Screen detects GADA and IA-2A。 Serum samples from 100 T1D patients at onset and 200 healthy controls were studied。 Results 3 Screen achieved 93% assay sensitivity and 97。5% specificity， while 2 Screen achieved 91% assay sensitivity and 98。5% specificity。 Samples were also tested in assays for individual autoantibodies。 There was only one 3 Screen positive healthy control sample (0。5%) that was positive for multiple autoantibodies (IA-2A and ZnT8A)。 In contrast， most of the 93 3 Screen positive patients were positive for multiple autoantibodies with 72% (67/93) positive for both GADA and IA-2A and 57% (53/93) positive for three autoantibodies (GADA， IA-2A and ZnT8A)。 Insulin autoantibodies (IAA， measured by radioimmunoassay) were positive in 13 patients and two healthy controls。 Conclusion 3 Screen achieved high sensitivity and specificity， suitable for islet cell autoimmunity screening in a healthy population。 In the case of 3 Screen positivity， further assays for GADA， IA-2A and ZnT8A are required to check for multiple autoantibody positivity， a hallmark for progression to T1D。 In addition， testing for IAA in children below two years of age is warranted。
NSTL
Springer Nature
