Protocol - Human Immunodeficiency Virus (HIV)
- Comprehensive HIV Risk Assessment
- Current Marital Status
- Self-report of Human Immunodeficiency Virus (HIV) Testing
Description
This protocol provides instructions for drawing, processing and storing blood for the human immunodeficiency virus (HIV) assay from the National Health and Nutrition Examination Survey (NHANES). Toolkit users are referred to the U.S. Food and Drug Administrations (FDAs) approved laboratory assays.
Specific Instructions
Availability
Protocol
The following is a summary version of the full National Health and Nutrition Examination Survey (NHANES) 2007–2008 protocol.
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[ ]Dont Know
If the SP answers, "Yes," the SP is excluded from the blood draw.
If the SP answers "No" or "Dont 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[ ]Dont Know
If the SP answers, "Yes," the SP is excluded from the blood draw.
If the SP answers "No" or "Dont Know," blood is drawn from the SP.
Note from the Infectious Diseases and Immunity Working Group (WG): The investigator should record the reason a person is excluded from the blood draw.
Venipuncture Procedures
Editors Note: Please review chapter 4 of the Laboratory Procedures Manual from the NHANES for a full description of Phlebotomy procedures: 2007–2008 NHANES Lab Manual
Venipuncture should generally be performed using the median cubital, cephalic, or basilic vein 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 right arm/hand.
Recording the Results of the Venipuncture Procedure
Immediately after completing the venipuncture, record the results of the blood draw, the reasons for a tube not being drawn according to the protocol, and any comments about the venipuncture.
Note from the Infectious Diseases and Immunity WG: The Infectious Diseases and Immunity WG recommends that the investigator record whether the blood was drawn and whether the full amount was obtained.
Process the Sample for the Serum
Editors Note: Please review chapter 8 of the Laboratory Procedures Manual from the NHANES 2007–2008 for a full description of Blood Processing procedures: 2007–2008 NHANES Lab Manual.
- Allow the blood to clot by setting aside for 30-45 minutes at room temperature. Do not clot for more than 1 hour.
- Centrifuge the tube at room temperature to separate the serum and aliquot into an appropriate storage tube.
- Determine if the serum is hemolyzed, turbid, lipemic, or icteric. If so, enter a comment to describe the plasma.
Laboratory Assay for Human Immunodeficiency Virus
There are now many laboratory assays that have been approved by the U.S. Food and Drug Administration (FDA). The Infectious Diseases and Immunity WG recommends that Toolkit users review the Centers for Disease Control and Preventions (CDCs) November 2001 Morbidity and Mortality Weekly Report (MMWR) Issue 44 on HIV testing. Once an assay is chosen for a particular study, the WG recommends that consistent methods are followed so that assay results will be comparable.
The CDC MMWR for HIV testing provides the following FDA-Approved HIV Testing Procedures beginning on page 35: FDA-Approved HIV Testing Procedures
To aid comparability, the Infectious Diseases and Immunity WG recommends that the investigator record the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.
Personnel and Training Required
Phlebotomist, and Laboratory that can perform the HIV assay
Equipment Needs
Phlebotomy supplies
Requirements
Requirement Category | Required |
---|---|
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
Adults, aged 18-59 years old
Selection Rationale
The National Health and Nutrition Examination Survey (NHANES) 2007-2008 protocol was selected as the best practice standardized methodology for blood collection, processing, and storage.
Language
Chinese, English, Other languages available at source
Standards
Standard | Name | ID | Source |
---|---|---|---|
Logical Observation Identifiers Names and Codes (LOINC) | HIV proto | 62882-6 | LOINC |
caDSR Form | PhenX PX160901 - Human Immunodeficiency Virus Hiv | 6185373 | caDSR Form |
Derived Variables
None
Process and Review
Not applicable.
Protocol Name from Source
National Health and Nutrition Examination Survey Questionnaire (NHANES), Laboratory Procedures Manual, 2007
Source
Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). (2007). National Health and Nutrition Examination Survey Questionnaire. Laboratory Procedures Manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.
Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). (2007). National Health and Nutrition Examination Survey Questionnaire. National Centers for Disease Control and Prevention Laboratory Procedures Manual for HIV Antibody/HIV Western Blot Confirmatory Test. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.
Centers for Disease Control and Prevention. Revised Guidelines for HIV Counseling, Testing, and Referral and Revised Recommendations for HIV Screening of Pregnant Women. MMWR 2001; 50 (No. RR-19).
General References
None
Protocol ID
160901
Variables
Export VariablesVariable Name | Variable ID | Variable Description | dbGaP Mapping | |
---|---|---|---|---|
PX160901_Assay_Repeatability | ||||
PX160901080000 | Repeatability of the assay | N/A | ||
PX160901_Blood_Draw_Comments | ||||
PX160901040200 | Record any comments about the blood draw, more | Variable Mapping | ||
PX160901_Blood_Draw_Done | ||||
PX160901040000 | Was blood drawn? | Variable Mapping | ||
PX160901_Blood_Draw_Sample | ||||
PX160901040100 | Was full amount obtained? | N/A | ||
PX160901_Chemotherapy | ||||
PX160901020000 | Have you received cancer chemotherapy in the more | Variable Mapping | ||
PX160901_Coefficient_Of_Variation | ||||
PX160901090000 | Coefficient of variation for the assay | N/A | ||
PX160901_Equipment_Make | ||||
PX160901070100 | Make of the equipment used to perform the more | N/A | ||
PX160901_Equipment_Manufacturer | ||||
PX160901070200 | Manufacturer of the equipment used to more | N/A | ||
PX160901_Exclusion_Criteria | ||||
PX160901030000 | Exclusion Criteria | N/A | ||
PX160901_Hemophilia | ||||
PX160901010000 | Do you have hemophilia? (exclusion from more | Variable Mapping | ||
PX160901_HIV_Assay_Results | ||||
PX160901100000 | HIV assay results | N/A | ||
PX160901_HIV_Assay_Type | ||||
PX160901060000 | Record the type of assay used for HIV testing. | N/A | ||
PX160901_Sample_Comments | ||||
PX160901050000 | Record any comments about the sample during more | Variable Mapping |
Measure Name
Human Immunodeficiency Virus (HIV)
Release Date
November 12, 2010
Definition
This is a bioassay to measure human immunodeficiency virus (HIV) antibodies.
Purpose
The measure determines whether a participant has human immunodeficiency virus (HIV) infection.
Keywords
Infectious disease, Human Immunodeficiency Virus, HIV, Bioassay, National Health and Nutrition Examination Survey, NHANES, Infectious Diseases and Immunity
Measure Protocols
Protocol ID | Protocol Name |
---|---|
160901 | Human Immunodeficiency Virus (HIV) |
Publications
Bartholomew, T. S., et al. (2024) Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services Addiction Science & Clinical Practice. 2024 March; 19(1). doi: 10.1186/s13722-024-00447-9