Table 1. Study Characteristics for Articles Reporting on Glycated Hemoglobin A1c (HbA1c) Performance Among African Descent Populations Living in the United States, 2010–2019.
| Study | First Author (Year); Study | N; Sex | Race/Ethnicitya (%) | Age, y | Location | Study Design | HbA1c Laboratory Analysis Method |
|---|---|---|---|---|---|---|---|
| African American | |||||||
| 1 | Bleyer (2010) (26) | N = 885; 43.2% male and 56.8% female | 43.5% African American; 56.5% White | ≥18 | Winston-Salem, North Carolina | Clinical; retrospective study | Cation-exchange column chromatography on an automated HPLC instrument (Variant II Turbo, Bio-Rad Laboratories). |
| 2 | Carson (2016); CARDIA study (27) | N = 2,692; 45.5% male and 54.5% female | 44% African American; 56% White | Mean (SD): 45.3 (3.6) | Minneapolis, Minnesota; Chicago, Illinois; Birmingham, Alabama; Oakland, California | Database analysis | Whole blood aliquot by ion-exchange HPLC using a Tosoh G7 (Tosoh Bioscience). |
| 3 | Cutrona (2015); FACHS (28) | N = 312; 100% female | 100% African American | 26–92; Mean (SD): 47 (7) | Ames, Iowa; Athens, Georgia | Database analysis | Whole blood aliquot by turbidimetric immunoinhibition (University of Iowa Clinical Pathology Laboratories). |
| 4 | Getaneh (2011); NHANES III and DIAMOND Study (29) | N = 16,056b; 48.1% male and 51.9% female | 4.3% Dominican; 28.9% Hispanic; 26.9% African American; 39.9% White | Range of mean ages: 38.2–63.3 | NHANES III: United States. DIAMOND: New York, New York |
Database analysis | Diamat HPLC from Bio-Rad Laboratories.c |
| 5 | Hivert (2019); DPP (30) | N = 2,658; 33% male and 67% female | 55.5% White; 20.2% African American; 17.0% Hispanic; 4.4% Asian; 2.9% American Indian | ≥25; Mean (SD): 50.7 (10.7) | 27 US clinical centersd | Clinical | Ion-exchange HPLC instrument (Variant; Bio-Rad Laboratories). |
| 6 | Homko (2012) (31) | N = 83; 7.2% male and 92.8% female | 100% African American | Mean (SD): 53 (10.4) | Philadelphia, Pennsylvania | Clinical | CDC-approved automated point-of-care analyzer (DCA 2000, Bayer Corporation): monoclonal antibody recognizes glycated N terminus of β chain of hemoglobin. |
| 7 | Meigs (2014); BACH Prediabetes Study (32) | N = 1,387; 37.4% male and 62.6% female | 27.3% African American; 29.6% Hispanic; 43.0% White | 34–87 | Boston, Massachusetts | Clinical | Tina-Quant HbA1c generation 2 assay with analytic measurement range of 3.4%–18% (Quest Diagnostics). |
| Afro-Caribbean | |||||||
| 8 | Exebio (2012) (33) | N = 128e | 100% Haitian American | ≥35 | Miami, Florida | Clinical | Whole blood with close tube sampling, in duplicate (coefficient of variation <1.7%), with Roche Tina Quant Second Generation A1c immunoassay method of Laboratory Corporation of America. |
| African | |||||||
| 9 | Briker (2019); The AIA Study (34) | N = 430; 65% male and 35% female | 100% African immigrants in the United States | Mean (SD): 38 (10) | Bethesda, Maryland | Clinical | NGSP-certified instruments: BioRad Laboratories Classic Variant (n = 32), Bio-Rad Laboratories Variant II (n = 158), and BioRad Laboratories D10 (n = 240) used sequentially by the NIH Clinical Center for HPLC. |
| 10 | Sumner 1 (2015); The AIA Study (35) | N = 216; 68% male and 32% female | 100% African immigrants in the United States | 20–64; mean (SD): 37 (10) | Bethesda, Maryland | Clinical | NGSP-certified instruments: Classic Variant, Variant II, and D10 for HPLC (Bio-Rad Laboratories). Whole blood samples in 90 participants analyzed by boronate affinity chromatography method on NGSP-certified Premier Hb9210 analyzer (Trinity Biotech). |
| 11 | Sumner 2 (2016); The AIA Study (36) | N = 236; 69% male and 31% female | 100% African immigrants in the United States | 20–64; Mean (SD): 39 (10) | Bethesda, Maryland | Clinical | NGSP-certified instruments: Variant II and D10 for HPLC (Bio-Rad Laboratories). |
| 12 | Sumner 3 (2016); The AIA Study (37) | N = 217; 69% male and 31% female | 100% African immigrants in the United States | 20–64; Mean (SD): 39 (10) | Bethesda, Maryland | Clinical | NGSP-certified instruments: Variant II and D10 for HPLC (Bio-Rad Laboratories). |
Abbreviations: AIA, Africans in America; BACH, Boston Area Community Health; CARDIA, Coronary Artery Risk Development in Young Adults; CDC, Centers for Disease Control and Prevention; DIAMOND, Diabetes Among Dominicans and Other Minorities in Northern Manhattan; DPP, Diabetes Prevention Program; FACHS, Family and Community Health Study; HPLC, high performance liquid chromatography; NHANES III, the third National Health and Nutrition Examination Survey; NIH, National Institutes of Health; NGSP, National Glycohemoglobin Standardization Program.
For all studies, White refers to Caucasian, Non-Hispanic White, and/or European White.
Participant data extracted from Table 1, “Sociodemographic Characteristics of Dominicans and the Third National Health and Nutrition Examination Survey Populations, Stratified by Hemoglobin A1c-Based Diabetes Diagnosis” (29).
Laboratory analysis data extracted from “Plan and Operation of the Third National Health and Nutrition Examination Survey, 1988–94. Series 1: Programs and Collection Procedures” (38).
Location data extracted from “The Diabetes Prevention Program. Design and methods for a clinical trial in the prevention of type 2 diabetes” (39).
Breakdown for sex/gender not available.