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Protocol - Hepatitis B - Assay

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Description:

This protocol provides instructions for drawing, processing, and storing blood for hepatitis B (HBV) from the National Health and Nutrition Examination Survey (NHANES). As multiple tests must be performed to make the most accurate diagnosis of HBV, the protocol also provides basic guidelines to aid comparability among different studies. 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 basilica 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 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 Hepatitis B

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 FDA's Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays to determine the appropriate assay for hepatitis B (HBV) 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.

To aid in 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

Laboratory capable of performing hepatitis B 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:

Child, Adult

Participants:

Children and adults, aged 2 years and older.

Specific Instructions:

Selection Rationale

The National Health and Nutrition Examination Survey (NHANES) 2007–2008 protocol was selected as the best standardized methodology for blood collection, processing, and storage. Hepatitis B has been measured in the NHANES since 1999.

Language

English, Spanish

Standards
StandardNameIDSource
Common Data Elements (CDE) Serological Hematology Hepatitis B Virus Core Antibody Laboratory Finding Result 2694945 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Assay for hepatitis B proto 62871-9 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.

U.S. Food and Drug Administration. Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays. (2009). Accessed September 8, 2010, from http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/

LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/UCM080466.

General References

Cohen, S. (2007). Acute viral hepatitis. In R. S. Porter & J. L. Kaplan (Eds.), MERCK Manual for Healthcare Professionals. Accessed September 8, 2010, from http://www.merck.com/mmpe/sec03/ch027/ch027b.html#sec03-ch027-ch027b-434.

Weinbaum, C. M., Williams, I., Mast, E. E., Wang, S. A., Finelli, L., Wasley, A., Neitzel, S. M., & Ward, J. W.; Centers for Disease Control and Prevention. (2008). Recommendations for identification and public health management of persons with chronic hepatitis B virus infection. Morbidity and Mortality Weekly Report, 57(RR-8), 1–20.

Protocol ID:

160401

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX160401_Assay_Repeatability PX160401080000 Repeatability of the assay 4 N/A
PX160401_Blood_Draw_Comments PX160401040200 Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol. 4 Variable Mapping
PX160401_Blood_Draw_Done PX160401040000 Was blood drawn? 4 Variable Mapping
PX160401_Blood_Draw_Sample PX160401040100 Was full amount obtained? 4 Variable Mapping
PX160401_Chemotherapy PX160401020000 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
PX160401_Coefficient_Of_Variation PX160401090000 Coefficient of variation for the assay 4 N/A
PX160401_Equipment_Make PX160401070100 Make of the equipment used to perform the hepatitis B assay. 4 N/A
PX160401_Equipment_Manufacturer PX160401070200 Manufacturer of the equipment used to perform the hepatitis B assay. 4 N/A
PX160401_Exclusion_Criteria PX160401030000 Exclusion Criteria 4 N/A
PX160401_Hemophilia PX160401010000 Do you have hemophilia? (exclusion from Phlebotomy) 4 Variable Mapping
PX160401_Hepatitis_B_Assay_Results PX160401100000 Hepatitis B assay results 4 N/A
PX160401_Hepatitis_B_Assay_Type PX160401060000 Record the type of assay used for hepatitis B testing. 4 N/A
PX160401_Sample_Comments PX160401050000 Record any comments about the sample during processing. 4 Variable Mapping
Research Domain Information
Measure Name:

Hepatitis B - Assay

Release Date:

November 12, 2010

Definition

This is a bioassay to measure hepatitis B (HBV).

Purpose

The measure determines whether a participant is infected with the hepatitis B virus (HBV). HBV constitutes a major public health problem because of the morbidity and mortality associated with the acute and chronic consequences of this infection. HBV can be spread by blood, bodily fluids, and at childbirth from the mother to the child. HBV infects the liver and can cause scarring (cirrhosis), liver failure, and liver cancer. Because of the high rate of asymptomatic infection, HBV often goes undetected.

Keywords

Infectious disease, Hepatitis B virus, HPV, National Health and Nutrition Examination Survey, NHANES, Infectious Diseases and Immunity