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Protocol - Hepatitis C - Assay

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Description:

This protocol provides instructions for drawing, processing, and storing blood for hepatitis C (HCV) from the National Health and Nutrition Examination Survey (NHANES). As multiple tests must be performed to make the most accurate diagnosis of hepatitis C, the protocol also provides basic guidelines to aid comparability among different studies. Toolkit users are referred to the U.S. Food and Drug Administrations (FDAs) approved laboratory assays.

Specific Instructions:

None

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 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

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 Antibody to Hepatitis C

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 recommend that Toolkit users review the FDAs approved assays for measuring the presence of antibody to hepatitis C (HCV). 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:

Availability:

Publicly available

Personnel and Training Required

Phlebotomist

Laboratory capable of performing hepatitis C antibody 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 6 years and older.

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 C has been measured in the NHANES since 1999.

Language

English, Spanish

Standards
StandardNameIDSource
Common Data Elements (CDE) Serological Hematology Hepatitis C Antibody Test Laboratory Finding Result 2695021 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Assay for hepatitis C proto 62869-3 LOINC
Human Phenotype Ontology Viral hepatitis HP:0006562 HPO
Derived Variables

None

Process and Review

Not applicable.

Source

Centers for Disease Control and Prevention (CDC). Division of Viral Hepatitis. Hepatitis C Information for Health Professionals. Accessed September 8, 2010 from http://www.cdc.gov/hepatitis/hcv/index.htm.

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. (2009). Hepatitis C. Accessed September 8, 2010, from http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm126581.htm.

General References

Alter, M. J., Kuhnert, W. L., & Finelli, L. (2003). Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. Morbidity and Mortality Weekly Report, 52(RR-3), 1–16.

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.

Protocol ID:

160301

Variables:
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX160301_Assay_Repeatability
PX160301080000 Repeatability of the assay N/A
PX160301_Blood_Draw_Comments
PX160301040200 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
PX160301_Blood_Draw_Done
PX160301040000 Was blood drawn? Variable Mapping
PX160301_Blood_Draw_Sample
PX160301040100 Was full amount obtained? Variable Mapping
PX160301_Chemotherapy
PX160301020000 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
PX160301_Coefficient_Of_Variation
PX160301090000 Coefficient of variation for the assay N/A
PX160301_Equipment_Make
PX160301070100 Make of the equipment used to perform the more
hepatitis C assay. show less
N/A
PX160301_Equipment_Manufacturer
PX160301070200 Manufacturer of the equipment used to more
perform the hepatitis C assay. show less
N/A
PX160301_Exclusion_Criteria
PX160301030000 Exclusion Criteria N/A
PX160301_Hemophilia
PX160301010000 Do you have hemophilia? (exclusion from more
Phlebotomy) show less
Variable Mapping
PX160301_Hepatitis_C_Assay_Results
PX160301100000 Hepatitis C assay results N/A
PX160301_Hepatitis_C_Assay_Type
PX160301060000 Record the type of assay used for hepatitis more
C testing. show less
N/A
PX160301_Sample_Comments
PX160301050000 Record any comments about the sample during more
processing. show less
Variable Mapping
Infectious Diseases and Immunity
Measure Name:

Hepatitis C Assay

Release Date:

November 12, 2010

Definition

This is a bioassay to detect antibody to hepatitis C virus (HCV).

Purpose

Hepatitis C virus (HCV) infection is the most common chronic blood-borne infection in the United States; approximately 3.2 million persons are chronically infected (Centers for Disease Control and Prevention 2008). The measure determines whether a participant has been infected with hepatitis C virus. Hepatitis viruses constitute a major public health problem because of the morbidity and mortality associated with the acute and chronic consequences of these infections.

Keywords

Infectious disease, Hepatitis C virus, HCV, Liver, Bioassay, National Health and Nutrition Examination Survey, NHANES, Infectious Diseases and Immunity