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22424 Chlamydia/GC, Nucleic Acid Method (NAM)

Chlamydia/GC, Nucleic Acid Method (NAM)
Test Code: CHGC
Synonyms/Keywords
​​​​Chlamydia/GC Nucleic Acid
Test Components
​CH-NAM, Chlamydia Trachomatis, Nucleic Acid Method (NAM)
GC-NAM, Neisseria Gonorrhoeae, Nucleic Acid Method (NAM)
Useful For
Detection of Chlamydia trachomatis and Neisseria gonorrhoeae directly from urine, female endocervical swabs, and Thin Prep samples and male urethral swab specimens. Male and female rectal, throat swab specimens.​
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)

​Urine - First catch

APTIMA urine specimen transport tube (Yellow labeled tube)

 ​ 20.0-30.0 mL ​2.0 mL ​
​Cervical Swab ​APTIMA Unisex blue shaft collection swab (White labeled tube) ​ ​ 1 s​wab​ ​
Male​Urethral Swab APTIMA Unisex blue shaft collection swab (White labeled tube)​ ​ ​ 1 s​wab​​ ​
​Vaginal Swab ​APTIMA multitest pink shaft collection swab (Orange labeled tube) ​ ​ ​1 s​wab​ ​
Rectal Swab​​APTIMA multitest pink shaft collection swab (Orange labeled tube)​​1 swab​​
​Throat Swab​APTIMA multitest pink shaft collection swab (Orange labeled tube)​​1 swab​​
Collection Processing Instructions
This test will not be performed on prepubescent children or for medico-legal situations. Please refer to Chlamydia culture in these circumstances.
 
1.  Male and female urine specimens transported in APTIMA urine specimen (yellow label) transport tube. Collect 20-30 ml of first catch urine (the first part of the stream).  Patient should not have urinated for at least 1 hour prior to specimen collection.  Transfer 2 ml of first-catch urine to APTIMA urine specimen tube.  Urine samples must be transferred to an APTIMA urine specimen tube within 24 hours of collection.
 
2.  Endocervical specimens from asymptomatic or symptomatic patients submitted in an APTIMA Unisex (white label) collection tube.  White shaft swab is for cleaning; blue shaft swab is for specimen collection.
 
3.  Male urethral swab specimens from asymptomatic or symptomatic patients submitted in an APTIMA Unisex (white label) colleciton tube. White shaft swab can be discarded; blue shaft swab is for specimen collection.  Patient should not have urinated for at least 1 hour priopr to specimen collection.
 
4.  Vaginal specimens from asymptomatic or symptomatic patients submitted in an APTIMA multitest (orange label) tube using the pink shaft swab. Specimen(s) are provider collected or patient collected in provider's office after thorough instructions.
 
5.  PreservCyt Thin Prep solution vial - see Cytology, PAP, Thin Prep for collection requirements.
 
6.  Rectal specimens from asymptomatic or symptomatic patients submitted in an APTIMA multitest (Orange label) tube using the pink shaft swab.
 
7.  Throat specimens from asymptomatic or symptomatic patients submitted in an APTIMA multitest (Orange label) tube using the pink shaft swab.
 
Collection Procedure Guides:
Urine Collection
Clinician Collected Vaginal Swab
Patient Collected Vaginal Swab
Unisex Swab Collection
 
For more information on Specimen Collection Media/Swab, see Specimen Transport Pictorial.
 
Specimen Stability Information
Specimen Type Temperature Time
APTIMA Unisex blue shaft collection swabs (white label)​ ​Ambient or Refrigerate ​60 days
​APTIMA urine specimen transport tube (yellow label) ​Ambient or Refrigerate ​30 days
​APTIMA Vaginal pink shaft swab (orange label) ​Ambient or Refrigerate ​​60 days
​PreservCyt solution vial ​Ambient ​2 weeks
PreservCyt solution vial​ ​Refrigerate ​30 days
Rejection Criteria
Vaginal specimens collected with blue swab in unisex (white label) tube​
Cervical specimens collected with pink swab in vaginal (orange label) tube
Improper specimen source (Eye)
Pre-pubescent children or Medico-Legal Cases​
Female urethral swabs​
Overfilling/underfilling of the APTIMA urine transport tube​
Rectal or throat specimens collected with blue swab in unisex (White label) tube​
​Volumes < 2 mL
​Volumes > 30 mL
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield ​Monday - Friday ​1 day Transcription-Mediated Amplification (TMA)
Test Information
The following applies to female urine sources:
This test was developed and its performance characteristics determined by Marshfield Labs. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity testing.
This test cannot be utilized in medico-legal situations or prepubescent children.  Culture is the recommended method in these cases and for rejected sample types listed in the rejection criteria section.
Reference Range Information
Performing Location Reference Range
​Marshfield

Negative for N. gonorrhoeae RNA by TMA 

Negative for Chlamydia trachomatis RNA by TMA. ​

Interpretation
​Reported as Negative, Positive, Indeterminate or Equivocal for Chlamydia trachomatis and Neisseria gonorrhoeae RNA by TMA. Equivocal results are inconclusive.  Repeat testing with a  new specimen is recommended. Indeterminate results are due to unidentified interference. Repeat testing with a new specimen is recommended.
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
87591​ ​ ​ Neisseria, amplified probe​ ​
87491​ ​ ​ Chlamydia, amplified probe​ ​
Classification
The following applies to female urine sources:
This test was developed and its performance characteristics determined by Marshfield Labs. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity testing.
Synonyms/Keywords
​​​​Chlamydia/GC Nucleic Acid
Test Components
​CH-NAM, Chlamydia Trachomatis, Nucleic Acid Method (NAM)
GC-NAM, Neisseria Gonorrhoeae, Nucleic Acid Method (NAM)
Ordering Applications
Ordering Application Description
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)

​Urine - First catch

APTIMA urine specimen transport tube (Yellow labeled tube)

 ​ 20.0-30.0 mL ​2.0 mL ​
​Cervical Swab ​APTIMA Unisex blue shaft collection swab (White labeled tube) ​ ​ 1 s​wab​ ​
Male​Urethral Swab APTIMA Unisex blue shaft collection swab (White labeled tube)​ ​ ​ 1 s​wab​​ ​
​Vaginal Swab ​APTIMA multitest pink shaft collection swab (Orange labeled tube) ​ ​ ​1 s​wab​ ​
Rectal Swab​​APTIMA multitest pink shaft collection swab (Orange labeled tube)​​1 swab​​
​Throat Swab​APTIMA multitest pink shaft collection swab (Orange labeled tube)​​1 swab​​
Collection Processing
This test will not be performed on prepubescent children or for medico-legal situations. Please refer to Chlamydia culture in these circumstances.
 
1.  Male and female urine specimens transported in APTIMA urine specimen (yellow label) transport tube. Collect 20-30 ml of first catch urine (the first part of the stream).  Patient should not have urinated for at least 1 hour prior to specimen collection.  Transfer 2 ml of first-catch urine to APTIMA urine specimen tube.  Urine samples must be transferred to an APTIMA urine specimen tube within 24 hours of collection.
 
2.  Endocervical specimens from asymptomatic or symptomatic patients submitted in an APTIMA Unisex (white label) collection tube.  White shaft swab is for cleaning; blue shaft swab is for specimen collection.
 
3.  Male urethral swab specimens from asymptomatic or symptomatic patients submitted in an APTIMA Unisex (white label) colleciton tube. White shaft swab can be discarded; blue shaft swab is for specimen collection.  Patient should not have urinated for at least 1 hour priopr to specimen collection.
 
4.  Vaginal specimens from asymptomatic or symptomatic patients submitted in an APTIMA multitest (orange label) tube using the pink shaft swab. Specimen(s) are provider collected or patient collected in provider's office after thorough instructions.
 
5.  PreservCyt Thin Prep solution vial - see Cytology, PAP, Thin Prep for collection requirements.
 
6.  Rectal specimens from asymptomatic or symptomatic patients submitted in an APTIMA multitest (Orange label) tube using the pink shaft swab.
 
7.  Throat specimens from asymptomatic or symptomatic patients submitted in an APTIMA multitest (Orange label) tube using the pink shaft swab.
 
Collection Procedure Guides:
Urine Collection
Clinician Collected Vaginal Swab
Patient Collected Vaginal Swab
Unisex Swab Collection
 
For more information on Specimen Collection Media/Swab, see Specimen Transport Pictorial.
 
Specimen Stability Information
Specimen Type Temperature Time
APTIMA Unisex blue shaft collection swabs (white label)​ ​Ambient or Refrigerate ​60 days
​APTIMA urine specimen transport tube (yellow label) ​Ambient or Refrigerate ​30 days
​APTIMA Vaginal pink shaft swab (orange label) ​Ambient or Refrigerate ​​60 days
​PreservCyt solution vial ​Ambient ​2 weeks
PreservCyt solution vial​ ​Refrigerate ​30 days
Rejection Criteria
Vaginal specimens collected with blue swab in unisex (white label) tube​
Cervical specimens collected with pink swab in vaginal (orange label) tube
Improper specimen source (Eye)
Pre-pubescent children or Medico-Legal Cases​
Female urethral swabs​
Overfilling/underfilling of the APTIMA urine transport tube​
Rectal or throat specimens collected with blue swab in unisex (White label) tube​
​Volumes < 2 mL
​Volumes > 30 mL
Useful For
Detection of Chlamydia trachomatis and Neisseria gonorrhoeae directly from urine, female endocervical swabs, and Thin Prep samples and male urethral swab specimens. Male and female rectal, throat swab specimens.​
Test Components
​CH-NAM, Chlamydia Trachomatis, Nucleic Acid Method (NAM)
GC-NAM, Neisseria Gonorrhoeae, Nucleic Acid Method (NAM)
Reference Range Information
Performing Location Reference Range
​Marshfield

Negative for N. gonorrhoeae RNA by TMA 

Negative for Chlamydia trachomatis RNA by TMA. ​

Interpretation
​Reported as Negative, Positive, Indeterminate or Equivocal for Chlamydia trachomatis and Neisseria gonorrhoeae RNA by TMA. Equivocal results are inconclusive.  Repeat testing with a  new specimen is recommended. Indeterminate results are due to unidentified interference. Repeat testing with a new specimen is recommended.
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield ​Monday - Friday ​1 day Transcription-Mediated Amplification (TMA)
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
87591​ ​ ​ Neisseria, amplified probe​ ​
87491​ ​ ​ Chlamydia, amplified probe​ ​
Classification
The following applies to female urine sources:
This test was developed and its performance characteristics determined by Marshfield Labs. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity testing.
For most current information refer to the Marshfield Laboratory online reference manual.