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Protocol - Human Immunodeficiency Virus (HIV)

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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

Available

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 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

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
StandardNameIDSource
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 Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX160901_Assay_Repeatability
PX160901080000 Repeatability of the assay N/A
PX160901_Blood_Draw_Comments
PX160901040200 Record any comments about the blood draw, more
including any reasons for the tube not being drawn according to the protocol. show less
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
past four weeks or do you anticipate such therapy in the next four weeks? (exclusion from Phlebotomy) show less
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
HIV assay. show less
N/A
PX160901_Equipment_Manufacturer
PX160901070200 Manufacturer of the equipment used to more
perform the HIV assay. show less
N/A
PX160901_Exclusion_Criteria
PX160901030000 Exclusion Criteria N/A
PX160901_Hemophilia
PX160901010000 Do you have hemophilia? (exclusion from more
Phlebotomy) show less
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
processing. show less
Variable Mapping
Infectious Diseases and Immunity
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