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Protocol - Herpes Simplex Virus Types 1 and 2 - Assay

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Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

Description:

This protocol provides information for drawing, processing, and storing blood for the herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) assay according to National Health and Nutrition Examination Survey (NHANES) methods. HSV-1 and HSV-2 are measured using the Solid-Phase Enzymatic Immunodot method.

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: [alink[NHANES_Lab_Manual.pdf|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: [alink[NHANES_Lab_Manual.pdf|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 Herpes Simplex Virus Type 1

The Infectious Diseases and Immunity WG recommends that herpes simplex virus type 1 and type 2 in serum be determined according to the Solid-Phase Enzymatic Immunodot assay used in the NHANES: [alink[NHANES_herpes_1_2_2007.pdf|Herpes Simplex Virus Types 1 and 2]]

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

Laboratory that can perform the Solid-Phase Enzymatic Immunodot assay

Equipment Needs

Phlebotomy supplies

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Health Professional

Life Stage:

Adolescent, Adult

Specific Instructions:

None

Research Domain Information

Release Date:

November 12, 2010

Definition

This is a bioassay to measure herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2). HSV-1 causes infections of the lips and mouth, such as cold sores and fever blisters. It is transmitted through saliva. Both HSV-1 and HSV-2 can cause genital herpes, a sexually transmitted disease (STD). Most genital herpes is caused by HSV-2.

Purpose

The bioassay determines whether a participant is infected with herpes simplex virus type 1 (HSV-1) and/or type 2 (HSV-2), a common infection in the United States. A total of 16.2%, or about one out of six people aged 14–49 years of age, have genital HSV-2 infection.

Selection Rationale

The National Health and Nutrition Examination Survey (NHANES) 2007-2008 protocol was selected as the best practice methodology and one of the most widely used protocols to measure herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2). This method has proven to be accurate, robust, and reproducible.

Language

English, Spanish

Standards

StandardNameIDSource
Common Data Elements (CDE)Antibody Herpes Simplex Virus Test Status2180471CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Assay herpes simplex 1-2 proto62873-5LOINC

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source

Centers for Disease Control and Prevention (CDC). (2007). National Center for Health Statistics (NCHS). National Health and Nutrition Examination Survey Questionnaire. Emory University Division of Infectious Diseases, Immunology and Epidemiology Laboratory Procedures Manual for Herpes Simplex Virus Type 1 by Solid-Phase Enzymatic Immunodot. 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. Laboratory Procedures Manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

General References

Lee, F. K., Pereira, L., & Griffin, C. (1986). A novel glycoprotein for detection of herpes simplex virus type 1–specific antibodies. Journal of Virological Methods, 14, 111–118.

Protocol ID:

160501

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX160501_HemophiliaPX160501010000Do you have hemophilia? (exclusion from Phlebotomy)4Variable Mapping
PX160501_ChemotherapyPX160501020000Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks? (exclusion from Phlebotomy)4N/A
PX160501_Exclusion_CriteriaPX160501030000Exclusion Criteria4N/A
PX160501_Blood_Draw_DonePX160501040000Was blood drawn?4Variable Mapping
PX160501_Blood_Draw_SamplePX160501040100Was full amount obtained?4Variable Mapping
PX160501_Blood_Draw_CommentsPX160501040200Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol.4Variable Mapping
PX160501_Sample_CommentsPX160501050000Record any comments about the sample during processing.4Variable Mapping
PX160501_HSV_Assay_TypePX160501060000Record the type of assay used for HSV testing.4N/A
PX160501_Equipment_MakePX160501070100Make of the equipment used to perform the HSV assay.4N/A
PX160501_Equipment_ManufacturerPX160501070200Manufacturer of the equipment used to perform the HSV assay.4N/A
PX160501_Assay_RepeatabilityPX160501080000Repeatability of the assay4N/A
PX160501_Coefficient_Of_VariationPX160501090000Coefficient of variation for the assay4N/A
PX160501_HSV_Type1_Assay_ResultsPX160501100000HSV Type 1 assay results4N/A
PX160501_HSV_Type2_Assay_ResultsPX160501110000HSV Type 2 assay results4N/A