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Protocol - Syphilis - Assay

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Description:

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

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 Syphilis

The Infectious Diseases and Immunity WG notes that although there is not a standardized assay, there are a number of different kits that are appropriate to measure syphilis. 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 syphilis 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 years and older

Specific Instructions:

None

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. Syphilis was measured in the NHANES from 2001–2004.

Language

English, Spanish

Standards
StandardNameIDSource
Common Data Elements (CDE) Serological Laboratory Procedure Syphilis Laboratory Finding Result 2695088 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Assay for syphilis proto 62877-6 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.

General References

Peterman, T., Schillinger, J., Blank, S., Berman, S., Ballard, R., Cox, D., Johnson, R., Hariri, S., & Selvam, N. (2008). Syphilis testing algorithms using treponemal tests for initial screening—Four laboratories, New York City, 2005–2006. Morbidity and Mortality Weekly Report, 57(32), 872–875.

Sena, A. C., White, B. L., & Sparling, P. F. (2010). Novel Treponema pallidum serologic tests: A paradigm shift in syphilis screening for the 21st century. Clinical Infectious Diseases, 51(6), 700–708.

Protocol ID:

160701

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX160701_Assay_Repeatability PX160701080000 Repeatability of the assay 4 N/A
PX160701_Blood_Draw_Comments PX160701040200 Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol. 4 Variable Mapping
PX160701_Blood_Draw_Done PX160701040000 Was blood drawn? 4 Variable Mapping
PX160701_Blood_Draw_Sample PX160701040100 Was full amount obtained? 4 Variable Mapping
PX160701_Chemotherapy PX160701020000 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
PX160701_Coefficient_Of_Variation PX160701090000 Coefficient of variation for the assay 4 N/A
PX160701_Equipment_Make PX160701070100 Make of the equipment used to perform the syphilis assay. 4 N/A
PX160701_Equipment_Manufacturer PX160701070200 Manufacturer of the equipment used to perform the syphilis assay. 4 N/A
PX160701_Exclusion_Criteria PX160701030000 Exclusion Criteria 4 N/A
PX160701_Hemophilia PX160701010000 Do you have hemophilia? (exclusion from Phlebotomy) 4 Variable Mapping
PX160701_Sample_Comments PX160701050000 Record any comments about the sample during processing. 4 Variable Mapping
PX160701_Syphilis_Assay_Results PX160701100000 Syphilis assay results 4 N/A
PX160701_Syphilis_Assay_Type PX160701060000 Record the type of assay used for syphilis testing. 4 N/A
Research Domain Information
Measure Name:

Syphilis - Assay

Release Date:

November 12, 2010

Definition

This is a bioassay to measure past or current infection with Treponema pallidum, the bacterium that causes syphilis.

Purpose

The measure determines whether a participant has been infected with Treponema pallidum, the bacterium that causes syphilis. The primary and secondary stages of syphilis are infectious and associated with fetal wastage and the congenital syphilis syndrome. They also increase the risk of human immunodeficiency virus (HIV) acquisition and transmission, while latent disease may be associated with the progression of HIV disease to acquired immune deficiency syndrome (AIDS) and more prominent neurologic disease in HIV-infected persons. The tertiary stage is associated with a vasculitis that may cause neurologic and cardiovascular manifestations and other chronic problems (National Health and Nutrition Examination Survey [NHANES] 2003–2004 Data Documentation).

Keywords

Infectious disease, Syphilis, Sexually transmitted disease, Bioassay, National Health and Nutrition Examination Survey, NHANES, Infectious Diseases and Immunity