Protocol - Herpes Simplex Virus Types 1 and 2 - Assay
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.
Specific Instructions
None
Availability
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 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: 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 Category | Required |
---|---|
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
Adolescent, Adult
Participants
Adolescents and adults, aged 14-49 years of age
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
Chinese, English, Other languages available at source
Standards
Standard | Name | ID | Source |
---|---|---|---|
Logical Observation Identifiers Names and Codes (LOINC) | Assay herpes simplex 1-2 proto | 62873-5 | LOINC |
Human Phenotype Ontology | Congenital Herpes Simplex Virus Infection | ORPHA:293 | HPO |
caDSR Form | PhenX PX160501 - Assay For Herpes Simplex Virus Types 1 And 2 | 6185175 | 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). (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 VariablesVariable Name | Variable ID | Variable Description | dbGaP Mapping | |
---|---|---|---|---|
PX160501_Assay_Repeatability | ||||
PX160501080000 | Repeatability of the assay | N/A | ||
PX160501_Blood_Draw_Comments | ||||
PX160501040200 | Record any comments about the blood draw, more | Variable Mapping | ||
PX160501_Blood_Draw_Done | ||||
PX160501040000 | Was blood drawn? | Variable Mapping | ||
PX160501_Blood_Draw_Sample | ||||
PX160501040100 | Was full amount obtained? | N/A | ||
PX160501_Chemotherapy | ||||
PX160501020000 | Have you received cancer chemotherapy in the more | Variable Mapping | ||
PX160501_Coefficient_Of_Variation | ||||
PX160501090000 | Coefficient of variation for the assay | N/A | ||
PX160501_Equipment_Make | ||||
PX160501070100 | Make of the equipment used to perform the more | N/A | ||
PX160501_Equipment_Manufacturer | ||||
PX160501070200 | Manufacturer of the equipment used to more | N/A | ||
PX160501_Exclusion_Criteria | ||||
PX160501030000 | Exclusion Criteria | N/A | ||
PX160501_Hemophilia | ||||
PX160501010000 | Do you have hemophilia? (exclusion from more | Variable Mapping | ||
PX160501_HSV_Assay_Type | ||||
PX160501060000 | Record the type of assay used for HSV testing. | N/A | ||
PX160501_HSV_Type1_Assay_Results | ||||
PX160501100000 | HSV Type 1 assay results | N/A | ||
PX160501_HSV_Type2_Assay_Results | ||||
PX160501110000 | HSV Type 2 assay results | N/A | ||
PX160501_Sample_Comments | ||||
PX160501050000 | Record any comments about the sample during more | Variable Mapping |
Measure Name
Herpes Simplex Virus Types 1 and 2 Assay
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.
Keywords
Infectious disease, Sexually transmitted disease, Herpes simplex virus, National Health and Nutrition Examination Survey, NHANES, Infectious Diseases and Immunity
Measure Protocols
Protocol ID | Protocol Name |
---|---|
160501 | Herpes Simplex Virus Types 1 and 2 - Assay |
Publications
There are no publications listed for this protocol.