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Childhood screening for type 1 diabetes comparing automated multiplex Antibody Detection by Agglutination-PCR (ADAP) with single plex islet autoantibody radiobinding assays
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- Lind, Alexander (författare)
- Lund University,Lunds universitet,Celiaki och diabetes,Forskargrupper vid Lunds universitet,Celiac Disease and Diabetes Unit,Lund University Research Groups,Lund Univ CRC, Dept Clin Sci, Malmö, Sweden.
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- Freyhult, Eva, 1979- (författare)
- Uppsala University,Uppsala universitet,Science for Life Laboratory, SciLifeLab,Beräkningsbiologi och bioinformatik,National Bioinformatics Infrastructure Sweden
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- de Jesus Cortez, Felipe (författare)
- Enable Biosci Inc, San Francisco, CA USA.,Enable Biosciences Inc.
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- (creator_code:org_t)
- Elsevier, 2024
- 2024
- Engelska.
- Ingår i: EBioMedicine. - : Elsevier. - 2352-3964. ; 104
- Tidskriftsartikel (refereegranskat)
Abstract
Ämnesord
Stäng
- BackgroundTwo or more autoantibodies against either insulin (IAA), glutamic acid decarboxylase (GADA), islet antigen-2 (IA-2A) or zinc transporter 8 (ZnT8A) denote stage 1 (normoglycemia) or stage 2 (dysglycemia) type 1 diabetes prior to stage 3 type 1 diabetes. Automated multiplex Antibody Detection by Agglutination-PCR (ADAP) assays in two laboratories were compared to single plex radiobinding assays (RBA) to define threshold levels for diagnostic specificity and sensitivity.MethodsIAA, GADA, IA-2A and ZnT8A were analysed in 1504 (54% females) population based controls (PBC), 456 (55% females) doctor's office controls (DOC) and 535 (41% females) blood donor controls (BDC) as well as in 2300 (48% females) patients newly diagnosed (1–10 years of age) with stage 3 type 1 diabetes. The thresholds for autoantibody positivity were computed in 100 10-fold cross-validations to separate patients from controls either by maximizing the χ2-statistics (chisq) or using the 98th percentile of specificity (Spec98). Mean and 95% CI for threshold, sensitivity and specificity are presented.FindingsThe ADAP ROC curves of the four autoantibodies showed comparable AUC in the two ADAP laboratories and were higher than RBA. Detection of two or more autoantibodies using chisq showed 0.97 (0.95, 0.99) sensitivity and 0.94 (0.91, 0.97) specificity in ADAP compared to 0.90 (0.88, 0.95) sensitivity and 0.97 (0.94, 0.98) specificity in RBA. Using Spec98, ADAP showed 0.92 (0.89, 0.95) sensitivity and 0.99 (0.98, 1.00) specificity compared to 0.89 (0.77, 0.86) sensitivity and 1.00 (0.99, 1.00) specificity in the RBA. The diagnostic sensitivity and specificity were higher in PBC compared to DOC and BDC.InterpretationADAP was comparable in two laboratories, both comparable to or better than RBA, to define threshold levels for two or more autoantibodies to stage type 1 diabetes.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Nyckelord
- Type 1 diabetes
- Insulin autoantibodies
- GAD65 autoantibodies
- IA-2 autoantibodies
- ZnT8 autoantibodies
- Radiobinding assay
- Antibody detection by agglutination PCR
- Diagnostic sensitivity
- Diagnostic specificity
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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- Lind, Alexander
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- Ramelius, Anita
- Bennet, Rasmus
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- Lernmark, Åke
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