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Protocol - Chlamydia/Gonorrhea - Assay

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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.

Protocol:

The following is a summary version of the full National Health and Nutrition Examination Survey (NHANES) 2007–2008 protocol.

Urine Collection

Editor's 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

Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

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 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:

Adolescent, Adult

Participants:

Adolescents and adults, aged 14–39 years old

Specific Instructions:

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

English, Spanish

Standards
StandardNameIDSource
Common Data Elements (CDE) Immunology Chlamydia trachomatis Assay Laboratory Finding Result 3151324 CDE Browser
Common Data Elements (CDE) Immunology Gonorrhea Assay Laboratory Finding Result 3153202 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Assay for chlamydia gonorrhea proto 62865-1 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). 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 NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX160101_Assay_Repeatability PX160101040000 Repeatability of the assay 4 N/A
PX160101_Chlamydia_Assay_Include_AC PX160101070000 Did the Chlamydia trachomatis assay include a separate Amplification Control (AC)? 4 N/A
PX160101_Chlamydia_Assay_Results_WithAC PX160101070100 If AC included, Chlamydia trachomatis assay results 4 N/A
PX160101_Chlamydia_Assay_Results_WithOutAC PX160101070200 If AC not included, Chlamydia trachomatis assay results 4 N/A
PX160101_Chlamydia_MOTA_Score PX160101060000 Chlamydia trachomatis MOTA (Method Other Than Acceleration) score 4 N/A
PX160101_Coefficient_Of_Variation PX160101050000 Coefficient of variation for the assay 4 N/A
PX160101_Equipment_Make PX160101030100 Make of the equipment used to perform Strand Displacement Amplification (SDA) Assay. 4 N/A
PX160101_Equipment_Manufacturer PX160101030200 Manufacturer of the equipment used to to perform Strand Displacement Amplification (SDA) Assay. 4 N/A
PX160101_Gonorrhea_Assay_Include_AC PX160101090000 Did the Neisseria gonorrhoeae assay include a separate Amplification Control (AC)? 4 N/A
PX160101_Gonorrhea_Assay_Results_WithAC PX160101090100 If AC included, Neisseria gonorrhoeae assay results 4 N/A
PX160101_Gonorrhea_Assay_Results_WithOutAC PX160101090200 If AC not included, Neisseria gonorrhoeae assay results 4 N/A
PX160101_Gonorrhea_MOTA_Score PX160101080000 Neisseria gonorrhoeae MOTA (Method Other Than Acceleration) score 4 N/A
PX160101_Sample_Comments PX160101020000 Record any comments about the urine during processing. 4 N/A
PX160101_Urine_Collection_Comments PX160101010000 Record any comments about the urine collection, including whether or not urine was collected, whether the volume of urine was sufficient or required a second specimen, and whether blood is present or visible in the specimen. 4 N/A
Research Domain Information
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