Protocol - Syphilis - Assay
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:
Personnel and Training Required
Phlebotomist
Laboratory capable of performing syphilis 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
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
| Standard | Name | ID | Source |
|---|---|---|---|
| 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 Name | Variable ID | Variable Description | Version | dbGaP 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 |
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