Feasibility and acceptability of islet autoantibody testing by home capillary blood sampling

Yuk-Fun Liu; Lisa Rafkin; Della  Matheson; Andrea K. Steck; Liping  Yu; Courtney  Henderson; Boulware David; Polly  Bingley

Feasibility and acceptability of islet autoantibody testing by home capillary blood sampling

Yuk-Fun Liu, Lisa Rafkin, Della Matheson, Andrea K. Steck, Liping Yu, Courtney Henderson, Boulware David, Polly Bingley

Diabetes

Research output: Chapter in Book/Report/Conference proceeding › Meeting abstract › peer-review

Abstract

Offering a simple and effective method for islet autoantibody (AAb) screening carried out at home could facilitate recruitment into large-scale type 1 diabetes (T1D) prevention studies. We evaluated the feasibility of self-collection of capillary blood samples (CBS) in relatives of individuals with T1D, enrolled via the TrialNet Pathway to Prevention Study. Sample collection kits were sent with instructions (also available as an online video) and a questionnaire. A minimum blood volume of 200µl was requested for detection of serum AAb to glutamic acid decarboxylase (GADA), islet antigen 2 (IA-2A) and insulin (IAA), with zinc transporter 8 (ZnT8A) tested if any of these AAb were positive. Successful collection was defined as sufficient volume and quality to allow definitive AAb results, including confirmation of positive results by repeat assay. In 245 individuals who returned samples, median age was 12 (range 1-49) years with 51% males, 33% ≤ 8 years, 41% 9-18 years and 26% >18 years. At time of analysis, 194 (97%) samples were considered successful for GADA and IA-2A screens, 163 (82%) for IAA and 162 (81%) for a complete AAb screen. Upper 90% confidence bounds for failures rates were 5.2% for combined GADA, IA-2A and ZnT8A assays, and 22.5% for IAA assay. In 216 questionnaires completed by adults, for themselves or on behalf of a child, 93 individuals (43%) considered CBS collection uncomfortable or painful. Nonetheless, 178 families (82%) preferred home CBS over outpatient venous sampling, 89% ≤8 years; 83% aged 9-18 years and 74% >18 years. The perceived difficulty of collecting CBS did not affect failure rate. Home collection of CBS for islet autoantibody testing is feasible and considered preferable to venous testing by families of people with T1D. Although, using current assays, some individuals with IAA alone may be missed, the method promises sensitive detection of GADA, IA-2A and ZnT8A and therefore of high risk, multiple AAb positive relatives potentially eligible for prevention trials.

Original language	English
Title of host publication	Diabetes
Volume	65
Edition	Supplement 1
Publication status	Published - 1 Jun 2016

Keywords

islet autoantibodies
capillary blood sampling

Cite this

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title = "Feasibility and acceptability of islet autoantibody testing by home capillary blood sampling",

abstract = "Offering a simple and effective method for islet autoantibody (AAb) screening carried out at home could facilitate recruitment into large-scale type 1 diabetes (T1D) prevention studies. We evaluated the feasibility of self-collection of capillary blood samples (CBS) in relatives of individuals with T1D, enrolled via the TrialNet Pathway to Prevention Study. Sample collection kits were sent with instructions (also available as an online video) and a questionnaire. A minimum blood volume of 200µl was requested for detection of serum AAb to glutamic acid decarboxylase (GADA), islet antigen 2 (IA-2A) and insulin (IAA), with zinc transporter 8 (ZnT8A) tested if any of these AAb were positive. Successful collection was defined as sufficient volume and quality to allow definitive AAb results, including confirmation of positive results by repeat assay. In 245 individuals who returned samples, median age was 12 (range 1-49) years with 51% males, 33% ≤ 8 years, 41% 9-18 years and 26% >18 years. At time of analysis, 194 (97%) samples were considered successful for GADA and IA-2A screens, 163 (82%) for IAA and 162 (81%) for a complete AAb screen. Upper 90% confidence bounds for failures rates were 5.2% for combined GADA, IA-2A and ZnT8A assays, and 22.5% for IAA assay. In 216 questionnaires completed by adults, for themselves or on behalf of a child, 93 individuals (43%) considered CBS collection uncomfortable or painful. Nonetheless, 178 families (82%) preferred home CBS over outpatient venous sampling, 89% ≤8 years; 83% aged 9-18 years and 74% >18 years. The perceived difficulty of collecting CBS did not affect failure rate. Home collection of CBS for islet autoantibody testing is feasible and considered preferable to venous testing by families of people with T1D. Although, using current assays, some individuals with IAA alone may be missed, the method promises sensitive detection of GADA, IA-2A and ZnT8A and therefore of high risk, multiple AAb positive relatives potentially eligible for prevention trials. ",

keywords = "islet autoantibodies, capillary blood sampling",

author = "Yuk-Fun Liu and Lisa Rafkin and Della Matheson and Steck, {Andrea K.} and Liping Yu and Courtney Henderson and Boulware David and Polly Bingley",

year = "2016",

month = jun,

day = "1",

language = "English",

volume = "65",

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edition = "Supplement 1",

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TY - CHAP

T1 - Feasibility and acceptability of islet autoantibody testing by home capillary blood sampling

AU - Liu, Yuk-Fun

AU - Rafkin, Lisa

AU - Matheson, Della

AU - Steck, Andrea K.

AU - Yu, Liping

AU - Henderson, Courtney

AU - David, Boulware

AU - Bingley, Polly

PY - 2016/6/1

Y1 - 2016/6/1

N2 - Offering a simple and effective method for islet autoantibody (AAb) screening carried out at home could facilitate recruitment into large-scale type 1 diabetes (T1D) prevention studies. We evaluated the feasibility of self-collection of capillary blood samples (CBS) in relatives of individuals with T1D, enrolled via the TrialNet Pathway to Prevention Study. Sample collection kits were sent with instructions (also available as an online video) and a questionnaire. A minimum blood volume of 200µl was requested for detection of serum AAb to glutamic acid decarboxylase (GADA), islet antigen 2 (IA-2A) and insulin (IAA), with zinc transporter 8 (ZnT8A) tested if any of these AAb were positive. Successful collection was defined as sufficient volume and quality to allow definitive AAb results, including confirmation of positive results by repeat assay. In 245 individuals who returned samples, median age was 12 (range 1-49) years with 51% males, 33% ≤ 8 years, 41% 9-18 years and 26% >18 years. At time of analysis, 194 (97%) samples were considered successful for GADA and IA-2A screens, 163 (82%) for IAA and 162 (81%) for a complete AAb screen. Upper 90% confidence bounds for failures rates were 5.2% for combined GADA, IA-2A and ZnT8A assays, and 22.5% for IAA assay. In 216 questionnaires completed by adults, for themselves or on behalf of a child, 93 individuals (43%) considered CBS collection uncomfortable or painful. Nonetheless, 178 families (82%) preferred home CBS over outpatient venous sampling, 89% ≤8 years; 83% aged 9-18 years and 74% >18 years. The perceived difficulty of collecting CBS did not affect failure rate. Home collection of CBS for islet autoantibody testing is feasible and considered preferable to venous testing by families of people with T1D. Although, using current assays, some individuals with IAA alone may be missed, the method promises sensitive detection of GADA, IA-2A and ZnT8A and therefore of high risk, multiple AAb positive relatives potentially eligible for prevention trials.

AB - Offering a simple and effective method for islet autoantibody (AAb) screening carried out at home could facilitate recruitment into large-scale type 1 diabetes (T1D) prevention studies. We evaluated the feasibility of self-collection of capillary blood samples (CBS) in relatives of individuals with T1D, enrolled via the TrialNet Pathway to Prevention Study. Sample collection kits were sent with instructions (also available as an online video) and a questionnaire. A minimum blood volume of 200µl was requested for detection of serum AAb to glutamic acid decarboxylase (GADA), islet antigen 2 (IA-2A) and insulin (IAA), with zinc transporter 8 (ZnT8A) tested if any of these AAb were positive. Successful collection was defined as sufficient volume and quality to allow definitive AAb results, including confirmation of positive results by repeat assay. In 245 individuals who returned samples, median age was 12 (range 1-49) years with 51% males, 33% ≤ 8 years, 41% 9-18 years and 26% >18 years. At time of analysis, 194 (97%) samples were considered successful for GADA and IA-2A screens, 163 (82%) for IAA and 162 (81%) for a complete AAb screen. Upper 90% confidence bounds for failures rates were 5.2% for combined GADA, IA-2A and ZnT8A assays, and 22.5% for IAA assay. In 216 questionnaires completed by adults, for themselves or on behalf of a child, 93 individuals (43%) considered CBS collection uncomfortable or painful. Nonetheless, 178 families (82%) preferred home CBS over outpatient venous sampling, 89% ≤8 years; 83% aged 9-18 years and 74% >18 years. The perceived difficulty of collecting CBS did not affect failure rate. Home collection of CBS for islet autoantibody testing is feasible and considered preferable to venous testing by families of people with T1D. Although, using current assays, some individuals with IAA alone may be missed, the method promises sensitive detection of GADA, IA-2A and ZnT8A and therefore of high risk, multiple AAb positive relatives potentially eligible for prevention trials.

KW - islet autoantibodies

KW - capillary blood sampling

UR - http://diabetes.diabetesjournals.org/content/65/Supplement_1

M3 - Meeting abstract

VL - 65

BT - Diabetes

ER -

Feasibility and acceptability of islet autoantibody testing by home capillary blood sampling

Abstract

Keywords

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