National Health and Nutrition Examination Survey

A urine pregnancy test was performed on female survey participants 8 years and older. If the urine pregnancy test was positive on any female participants aged 8-17 years, the result was confirmed using a serum test. All positive test results excluded pregnant women from the DXA component at the mobile examination center (MEC).

Examined female participants aged 12–59 years, and menstruating females aged 8–11 years were eligible. However, due to disclosure risks, only females 20-44 years of age have urine pregnancy results in this file.

The Icon 25 hCG test kit (Beckman Coulter) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine or serum.

There were no changes to the lab method, lab equipment, or lab site for this component in the NHANES 2015-2016 cycle.

Urine and serum specimens were tested in the NHANES mobile examination centers.

Detailed instructions on specimen collection and processing are discussed in the NHANES Laboratory Procedures Manual (LPM).

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.”

Mobile Examination Centers (MECs)

Laboratory team performance is monitored using several techniques. NCHS and contract consultants use a structured quality assurance evaluation during unscheduled 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.

The data were reviewed. Incomplete data or improbable values were sent to the performing laboratory for confirmation.

Refer to the 2015-2016 Laboratory Data Overview for general information on NHANES laboratory data.

Demographic and Other Related Variables

The analysis of NHANES laboratory data must be conducted using the appropriate survey design and demographic variables. The NHANES 2015-2016 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.

This laboratory data file can be linked to the other NHANES data files using the unique survey participant identifier (i.e., SEQN).

Detection Limits

Since this data is reported as qualitative data, the use of lower LLOD is not applicable.

Exam sample weights should be used for analyses. Please refer to the NHANES Analytic Guidelines and the on-line NHANES Tutorial for further details on the use of sample weights and other analytic issues.