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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 Administration's (FDA's) approved laboratory assays.

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 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.

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

Editor's 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

Editor's 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 Prevention's (CDC's) 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.

Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

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

Life Stage:

Adult

Participants:

Adults, aged 18-59 years old

Specific Instructions:

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

English, Spanish

Standards
StandardNameIDSource
Common Data Elements (CDE) Antibody HIV Test Status 2180464 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) HIV proto 62882-6 LOINC
Derived Variables

None

Process and Review

The Expert Review Panel has not reviewed this measure yet.

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 NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX160901_Assay_Repeatability PX160901080000 Repeatability of the assay 4 N/A
PX160901_Blood_Draw_Comments PX160901040200 Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol. 4 Variable Mapping
PX160901_Blood_Draw_Done PX160901040000 Was blood drawn? 4 Variable Mapping
PX160901_Blood_Draw_Sample PX160901040100 Was full amount obtained? 4 Variable Mapping
PX160901_Chemotherapy PX160901020000 Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks? (exclusion from Phlebotomy) 4 N/A
PX160901_Coefficient_Of_Variation PX160901090000 Coefficient of variation for the assay 4 N/A
PX160901_Equipment_Make PX160901070100 Make of the equipment used to perform the HIV assay. 4 N/A
PX160901_Equipment_Manufacturer PX160901070200 Manufacturer of the equipment used to perform the HIV assay. 4 N/A
PX160901_Exclusion_Criteria PX160901030000 Exclusion Criteria 4 N/A
PX160901_Hemophilia PX160901010000 Do you have hemophilia? (exclusion from Phlebotomy) 4 Variable Mapping
PX160901_HIV_Assay_Results PX160901100000 HIV assay results 4 N/A
PX160901_HIV_Assay_Type PX160901060000 Record the type of assay used for HIV testing. 4 N/A
PX160901_Sample_Comments PX160901050000 Record any comments about the sample during processing. 4 Variable Mapping
Research Domain Information
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