In 2015, diabetes was the seventh leading cause of death in the United States. More than 30 million Americans are living with diabetes, and 86 million are living with prediabetes, which is a serious health condition that increases a person’s risk of type 2 diabetes and other chronic diseases. The prevalence of diabetes and overweight (one of the major risk factors for diabetes) continue to increase. Substantial new efforts to prevent or control diabetes have begun, including the Diabetes Prevention Trial and the National Diabetes Education Program.
Diabetes testing provides population data to: 1) determine a national estimate of diabetes prevalence (diagnosed and undiagnosed); 2) identify the risk factors; 3) permit a national cohort to be established for follow-up studies of this condition; and 4) provide critical information to clinicians and public health officials for the development of preventive care and community-based interventions.
Examined participants aged 12 years and older were eligible.
In this assay, the stable (SA1c) and labile (LA1c) A1c forms can be individually resolved on the chromatogram without manual pretreatment, allowing accurate measurement of the stable form of HbA1c. The analyzer dilutes the whole blood specimen with a hemolysis solution, and then injects a small volume of the treated specimen onto the HPLC analytical column. Separation is achieved by utilizing differences in ionic interactions between the cation exchange group on the column resin surface and the hemoglobin components. The hemoglobin fractions (A1c, A1b, F, LA1c, SA1c, A0 and H-Var) are subsequently removed from the column material by step-wise elution using elution buffers each with a different salt concentration. The separated hemoglobin components pass through the photometer flow cell where the analyzer measures changes in absorbance at 415 nm. The analyzer integrates and reduces the raw data, and then calculates the relative percentages of each hemoglobin fraction. Analysis requires three minutes. If a specimen showed a deterioration peak, hemoglobin variant, or a LA1c results ≥ 5% and/or LA1c results > half SA1c during the regular test, it would be retested by a second method, ultra 2 HPLC. In the 2017-2018 cycle, only 2.2% of the blood specimens required to be retested by the ultra 2 HPLC method. A lab instrumentation change was made for this secondary method during the data collection period. This instrument change did not significantly affect the resulted glycohemoglobin values; the mean relative error between results from the two instruments was 0.5% (ranged from -4.0% to 5.2%).
Refer to the Laboratory Method Files section for a detailed description of the laboratory methods used.
Other than the minor change in the secondary ultra 2 HPLC method described above, there were no changes to the lab method, lab equipment, or lab site for this component in the NHANES 2017-2018 cycle.
Glycohemoglobin_Premier (February 2020)
Glycohemoglobin_G8 (February 2020)
Whole blood specimens were processed, stored, and shipped to the University of Missouri-Columbia, MO for analysis.
Detailed instructions on specimen collection and processing are discussed in the NHANES Laboratory Procedures Manual (LPM). Vials are stored under appropriate refrigerated (2-8°C) conditions until they were shipped to University of Missouri for testing.
The NHANES quality assurance and quality control (QA/QC) protocols meet the 1988 Clinical Laboratory Improvement Act mandates. Detailed QA/QC instructions are discussed in the NHANES LPM.
Laboratory team performance is monitored using several techniques. NCHS and contract consultants use a structured competency assessment evaluation during visits to evaluate both the quality of the laboratory work and the quality control procedures. Each laboratory staff member is observed for equipment operation, specimen collection and preparation; testing procedures and constructive feedback are given to each staff member. Formal retraining sessions are conducted annually to ensure that required skill levels were maintained.
NHANES uses several methods to monitor the quality of the analyses performed by the contract laboratories. In the MEC, these methods include performing blind split samples collected on “dry run” sessions. In addition, contract laboratories randomly perform repeat testing on 2% of all specimens.
NCHS developed and distributed a quality control protocol for all CDC and contract laboratories, which outlined the use of Westgard rules (Westgard et al., 1981) when running NHANES specimens. Progress reports containing any problems encountered during shipping or receipt of specimens, summary statistics for each control pool, QC graphs, instrument calibration, reagents, and any special considerations are submitted to NCHS quarterly. The reports are reviewed for trends or shifts in the data. The laboratories are required to explain any identified areas of concern.
The data were reviewed. Incomplete data or improbable values were sent to the performing laboratory for confirmation.
Refer to the 2017 - 2018 Laboratory Data Overview for general information on NHANES laboratory data.
There are over 800 laboratory tests performed on NHANES participants. However, not all participants provided biospecimens or enough volume for all the tests to be performed. The specimen availability can also vary by age or other population characteristics. For example, in 2017-2018, approximately 80% of children aged 1-17 years who were examined in the MEC provided a blood specimen through phlebotomy, while 95% of examined adults age 18 and older provided a blood specimen. Analysts should evaluate the extent of missing data in the dataset related to the outcome of interest as well as any predictor variables used in the analyses to determine whether additional re-weighting for item non-response is necessary.
Demographic and Other Related Variables
The analysis of NHANES laboratory data must be conducted using the appropriate survey design and demographic variables. The NHANES 2017-2018 Demographics File contains demographic data, health indicators, and other related information collected during household interviews as well as the sample design variables. The recommended procedure for variance estimation requires use of stratum and PSU variables (SDMVSTRA and SDMVPSU, respectively) in the demographic data file.
The Fasting Questionnaire File includes auxiliary information, such as fasting status, length of fast and the time of venipuncture.
This laboratory data file can be linked to the other NHANES data files using the unique survey participant identifier (i.e., SEQN).
this data is reported in percent, the use of lower LLODs isn’t applicable.
|Code or Value||Value Description||Count||Cumulative||Skip to Item|
|3.8 to 16.2||Range of Values||6045||6045|