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Protocol - Testosterone Level - Bioassay

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Description

This protocol provides instructions for drawing, processing, and storing blood for the testosterone assay according to the National Health and Nutrition Examination Survey (NHANES) 2011-2012 methods. 

Specific Instructions

None.

Availability

Available

Protocol

National Health and Nutrition Examination Survey (NHANES) 2011-2012 Total Testosterone

The following is a summary version of information from the National Health and Nutrition Examination Survey (NHANES) 2011-2012 Laboratory Procedure Manual. 

Utilize a trained and experienced phlebotomist for venipuncture.

Equipment and supplies needed

Standard venipuncture supplies

6 to 10 mL red top tube

2 mL cryovial with external screw caps

Personal protective equipment

Centrifuge

-70°C Freezer

A morning fasting blood sample is recommended to minimize variability. During the National Health and Nutrition Examination Survey (NHANES), participants fasted for a minimum of 9 hours. 

Exclusion criteria

Persons will be excluded from this component if they:

• Report that they have hemophilia; or

• Report that they have received cancer chemotherapy in the last 4 weeks

SP = Sample Person.

1. Do you have hemophilia?

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers "Yes," the SP is excluded from the blood draw. If the SP answers "No" or "Don’t Know," blood is drawn from the SP.

2. Have you received cancer chemotherapy in the past 4 weeks, or do you anticipate such therapy in the next 4 weeks?

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers "Yes," the SP is excluded from the blood draw. If the SP answers "No" or "Don’t Know," blood is drawn from the SP.

Venipuncture

Venipuncture should generally be performed using the median cubital, cephalic, or basilic veins in the left arm unless this arm is unsuitable. If the veins in the left arm are unsuitable, look for suitable veins on the right arm. If the veins in the antecubital space on both arms are not suitable, then look for veins in the forearm or dorsal side of the hand on the left arm/hand and then the right arm/hand.

Processing

If blood left at ambient temperature, serum should be centrifuged within 6 hours of venipuncture. Aliquot the supernatant to a 2 mL cryovial with external screw caps. A minimum of 0.5 mL of serum is required for the total testosterone assay. 

Storage

If testosterone assay is not possible for several days, store serum sample in freezer box in a -70°C freezer. Serum samples could be stored up to 3 days in a refrigerator if analysis is possible in that timeframe. 

Analyses

The Sickle Cell Disease Genitourinary Working Group notes that there are a number of different assays and instruments that are appropriate to measure the concentration of testosterone levels. Once an assay is chosen for a particular study, the Working Group recommends that no changes in the protocol be made over the course of the study. To aid in comparability, the Working Group recommends that the investigator record the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.

If results are being provided back to participants, a CLIA certified laboratory must be used. Commercial laboratories perform total testosterone assays on a routine basis. 

Reference Ranges (Bhasin et al., 2006)

The minimum value for the range of total testosterone in healthy young men is 300 ng/dL.

Personnel and Training Required

Laboratory training for sample collection, sample preparation, sample handling, and in the use of the testosterone assay.

Equipment Needs

Laboratory capable of performing testosterone assay.

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Bioassay

Lifestage

Adult

Participants

Adult males

Selection Rationale

The National Health and Nutrition Examination Survey 2011-2012 manual was selected as the best standardized method for blood collection, sample processing and storage for the determination of testosterone levels. The reference ranges are taken from the national clinical recommendations for the established body of endocrinology experts in the medical field.

Language

English

Standards
StandardNameIDSource
Derived Variables

Not applicable

Process and Review

Not applicable

Protocol Name from Source

National Health and Nutrition Examination Survey (NHANES) 2011-2012, Total Testosterone

Source

Centers for Disease Control and Prevention, National Center for Health Statistics. National Health and Nutrition Examination Survey (NHANES), 2011-2012, Laboratory procedure manual: Total testosterone.

General References

Bhasin, S., Cunningham, G. R., Hayes, F. J., Matsumoto, A. M., Snyder, P. J., Swerdloff, R. S., & Montori, V. M. (2006). Testosterone therapy in adult men with androgen deficiency syndromes: An Endocrine Society clinical practice guideline. Journal of Clinical Endocrinology & Metabolism, 91(6), 1995–2010. https://doi.org/10.1210/jc.2005-2847

Protocol ID

880201

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX880201_Testosterone_Level_Cancer_Chemotherapy_Past_4_Weeks
PX880201020000 Have you received cancer chemotherapy in the more
past 4 weeks, or do you anticipate such therapy in the next 4 weeks? show less
N/A
PX880201_Testosterone_Level_Coefficient_Variation_Assay
PX880201070000 What is the coefficient of variation of the more
assay used? show less
N/A
PX880201_Testosterone_Level_Hemophilia
PX880201010000 Do you have hemophilia? N/A
PX880201_Testosterone_Level_Make_Equipment
PX880201050000 What is the make of the equipment used? N/A
PX880201_Testosterone_Level_Manufacturer_Equipment
PX880201040000 What is the manufacturer of equipment used? N/A
PX880201_Testosterone_Level_Measurement
PX880201030100 What is the measured value of testosterone levels? N/A
PX880201_Testosterone_Level_Measurement_Unit
PX880201030200 What is the measured value of testosterone more
levels? - Units show less
N/A
PX880201_Testosterone_Level_Repeatability_Assay
PX880201060000 What is the repeatability of the assay used? N/A
SCD Genitourinary
Measure Name

Testosterone Level

Release Date

August 15, 2023

Definition

Testosterone is the primary male sex hormone.

Purpose

Testosterone levels are associated with energy, muscle mass, sperm production, and male fertility. A serum total testosterone level less than 300 ng/dL in adult males is associated with testosterone deficiency.

Keywords

biomarker, testosterone, serum, laboratory protocol, Centers for Disease Control and Prevention, CDC, National Health and Nutrition Examination Survey, NHANES

Measure Protocols
Protocol ID Protocol Name
880201 Testosterone Level - Bioassay
Publications

There are no publications listed for this protocol.