Protocol - Chlamydia/Gonorrhea - Assay
Description
This protocol provides basic instructions for collecting and processing urine according to National Health and Nutrition Examination Survey (NHANES) methods for assessing the presence of Chlamydia trachomatis and/or Neisseria gonorrhoeae, sexually transmitted bacterial diseases. Strand Displacement Amplification Assay is the method used.
Specific Instructions
Availability
Protocol
The following is a summary version of the full National Health and Nutrition Examination Survey (NHANES) 2007–2008 protocol.
Urine Collection
Editors Note: Please review chapter 5 of the Laboratory Procedures Manual from the NHANES 2007–2008 for a full description of urine collection and processing procedures: 2007-2008 NHANES Lab Manual.
The coordinator explains the following instructions to the subject before urine collection:
- Wash hands with soap and water.
- It is important that the cup and cap not touch or come into contact with any parts of the body, clothing, or external surfaces.
- Close container to minimize exposure to air.
Refrigerate all insufficient urine samples. When additional urine is obtained, pool the urine, mix, and process.
Record the Results of Urine Specimen Collection
Note whether or not urine was collected, whether the volume of urine was sufficient or required a second specimen.
Note whether blood is present/visible in the specimen.
Laboratory Procedure for Chlamydia/Gonorrhea
The Infectious Diseases and Immunity Working Group (WG) recommends that Chlamydia trachomatis and Neisseria gonorrhoeae be determined according to the Strand Displacement Amplification (SDA) Assay developed by the National Center for Infectious Diseases, the Center for Disease Control and Prevention, for use in the NHANES: Chlamydia trachomatis and Neisseria gonorrhoeae
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.
Reference Ranges
Chlamydia trachomatis and Neisseria gonorrhoeae Result Interpretation With the Amplification Control (AC)
| CT or GC MOTA Score | AC MOTA Score | Report | Interpretation | Result |
| ≥10,000 | Any | C. trachomatis plasmid and/or N. gonorrhoeae DNA detected by SDA | Positive for C. trachomatis and/or N.gonorrhoeae. C. trachomatis and/or N.gonorrhoeae organism viability and/or infectivity cannot be inferred because target DNA may persist in the absence of viable organisms. | Positive |
| 2,000–9,999 | Any | C. trachomatis plasmid and/or N. gonorrhoeae DNA detected by SDA | C. trachomatis and/or N.gonorrhoeae likely. Repeat testing may be useful for verifying presence of C. trachomatis and/or N.gonorrhoeae. | Low Positive |
| <2000 | ≥1000 | C. trachomatis plasmid and/or N. gonorrhoeae DNA NOT detected by SDA | Presumed negative for C. trachomatis and/or N.gonorrhoeae. A negative result does not preclude C. trachomatis and/or N.gonorrhoeae infection because results are dependent on adequate specimen collection, absence of inhibitors, and sufficient DNA to be detected. | Negative |
| <2000 | <1000 | Amplification Control inhibited. Repeat test. | Repeatedly inhabited specimen. C. trachomatis and/or N.gonorrhoeae, if present, would not be detectable using SDA. Submit another specimen for testing. | Indeterminate |
Chlamydia trachomatis and Neisseria gonorrhoeae Result Interpretation Without the AC
| CT or GC MOTA Score | Report | Interpretation | Result |
| ≥10,000 | C. trachomatis plasmid and/or N. gonorrhoeae DNA detected by SDA | Positive for C. trachomatis and/or N.gonorrhoeae. C. trachomatis and/or N.gonorrhoeae organism viability and/or infectivity cannot be inferred because target DNA may persist in the absence of viable organisms. | Positive |
| 2,000-9,999 | C. trachomatis plasmid and/or N. gonorrhoeae DNA detected by SDA | C. trachomatis and/or N.gonorrhoeae likely. Repeat testing may be useful for verifying presence of C. trachomatis and/or N.gonorrhoeae. | Low Positive |
| < 2000 | C. trachomatis plasmid and/or N. gonorrhoeae DNA NOT detected by SDA | Presumed negative for C. trachomatis and/or N.gonorrhoeae. A negative result does not preclude C. trachomatis and/or N.gonorrhoeae infection because results are dependent on adequate specimen collection, absence of inhibitors, and sufficient DNA to be detected. | Negative |
Personnel and Training Required
Personnel to collect the urine
Laboratory to perform the Strand Displacement Amplification assay
Equipment Needs
Supplies to collect and process urine
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 14–39 years old
Selection Rationale
The National Health and Nutrition Examination Survey (NHANES) 2007–2008 protocol was selected as the best practice methodology and as one of the most widely used protocols to measure Chlamydia trachomatis and Neisseria gonorrhoeae.
Language
Chinese, English, Other languages available at source
Standards
| Standard | Name | ID | Source |
|---|---|---|---|
| Logical Observation Identifiers Names and Codes (LOINC) | Assay for chlamydia gonorrhea proto | 62865-1 | LOINC |
| caDSR Form | PhenX PX160101 - Assay For Chlamydia Gonorrhea | 6180357 | 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). National Center for Health Statistics (NCHS). National Health and Nutrition Examination Survey Questionnaire. (2007). National Centers for Disease Control and Prevention Laboratory Procedures Manual for Chlamydia trachomatis by BDProbeTec Analyzer. 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
Akduman, D., Ehret, J. M., Messina, K., Ragsdale, S., & Juson, F. N. (2002). Evaluation of a Strand Displacement Amplification Assay (BD ProbeTec-SDA) for detection of Neisseria gonorrhoeae in urine specimens. Journal of Clinical Microbiology, 40(1), 281–283.
Bachmann, L. H. (2010). Nucleic acid amplification tests for diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis rectal infections. Journal of Clinical Microbiology, 48(5):1827–1832.
Black, C. M. (1997). Current methods of laboratory diagnosis of Chlamydia trachomatis infections. Clinical Microbiology Reviews, 10(1), 160–184.
Protocol ID
160101
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX160101_Assay_Repeatability | ||||
| PX160101040000 | Repeatability of the assay | N/A | ||
| PX160101_Chlamydia_Assay_Include_AC | ||||
| PX160101070000 | Did the Chlamydia trachomatis assay include more | N/A | ||
| PX160101_Chlamydia_Assay_Results_WithAC | ||||
| PX160101070100 | If AC included, Chlamydia trachomatis assay more | N/A | ||
| PX160101_Chlamydia_Assay_Results_WithOutAC | ||||
| PX160101070200 | If AC not included, Chlamydia trachomatis more | N/A | ||
| PX160101_Chlamydia_MOTA_Score | ||||
| PX160101060000 | Chlamydia trachomatis MOTA (Method Other more | N/A | ||
| PX160101_Coefficient_Of_Variation | ||||
| PX160101050000 | Coefficient of variation for the assay | N/A | ||
| PX160101_Equipment_Make | ||||
| PX160101030100 | Make of the equipment used to perform Strand more | N/A | ||
| PX160101_Equipment_Manufacturer | ||||
| PX160101030200 | Manufacturer of the equipment used to to more | N/A | ||
| PX160101_Gonorrhea_Assay_Include_AC | ||||
| PX160101090000 | Did the Neisseria gonorrhoeae assay include more | N/A | ||
| PX160101_Gonorrhea_Assay_Results_WithAC | ||||
| PX160101090100 | If AC included, Neisseria gonorrhoeae assay more | N/A | ||
| PX160101_Gonorrhea_Assay_Results_WithOutAC | ||||
| PX160101090200 | If AC not included, Neisseria gonorrhoeae more | N/A | ||
| PX160101_Gonorrhea_MOTA_Score | ||||
| PX160101080000 | Neisseria gonorrhoeae MOTA (Method Other more | N/A | ||
| PX160101_Sample_Comments | ||||
| PX160101020000 | Record any comments about the urine during more | Variable Mapping | ||
| PX160101_Urine_Collection_Comments | ||||
| PX160101010000 | Record any comments about the urine more | N/A | ||
Measure Name
Chlamydia/Gonorrhea Assay
Release Date
November 12, 2010
Definition
A bioassay to measure Chlamydia trachomatis and Neisseria gonorrhoeae, sexually transmitted bacterial diseases.
Purpose
The measure determines whether a participant has Chlamydia trachomatis and/or Neisseria gonorrhoeae. Chlamydia trachomatis is one of the most frequently reported sexually transmitted bacterial diseases (STDs) in the United States. Chlamydia trachomatis is known to cause pelvic inflammatory disease, ectopic pregnancy, cervicitis, urethritis, salpingitis, proctitis, and endometritis in women and urethritis, epididymitis, and proctitis in men. STDs are frequently asymptomatic in women and often are undiagnosed.
Keywords
Infectious disease, Chlamydia trachomatis, Sexually-transmitted disease, Bacterial disease, Urine sample, Neisseria gonorrhoeae, National Health and Nutrition Examination Survey, NHANES, Infectious Diseases and Immunity
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 160101 | Chlamydia/Gonorrhea - Assay |
Publications
There are no publications listed for this protocol.