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22901 Neisseria Gonorrhoeae, Nucleic Acid Method (NAM)

Neisseria Gonorrhoeae, Nucleic Acid Method (NAM)
Test Code: GC-NAM
Synonyms/Keywords
​​Neisseria gonorrhoea, Gonorrhea, GC
Useful For
Detection of Neisseria gonorrhoeae from urine and male urethral swab specimens, female endocervical swabs, Thin Prep samples, and vaginal 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 swab​
Male​Urethral Swab ​APTIMA Unisex blue shaft collection swab (White labeled tube) ​1 swab
​Vaginal Swab ​APTIMA multitest pink shaft collection swab (Orange labeled tube) ​1 swab
​Rectal SwabAPTIMA multitest pink shaft collection swab (Orange labeled tube)​​1 swab
​Throat SwabAPTIMA multitest pink shaft collection swab (Orange labeled tube)​1 swab​

​Thin Prep
​PreservCyt Thin Prep solution vial
(See Cytology, PAP, Thin Prep for collection requirements [see note #5 in the Collection Processing Instructions])




​1 vial​
Collection Processing Instructions
​This test will not be performed on prepubescent children or for medico-legal situations. 

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 2ml 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 a APTIMA Unisex (white label) collection tube. White shaft swab can be discarded; blue shaft swab is for specimen collection. Patient should not have urinated for at least 1 hour prior 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 instruction.

5. PreservCyt Thin Prep solution vial – see Cytology, PAP, Thin Prep for collection requirements.
 
6.  Rectal specimens from asymptomatic or symptomatic patients submitted in a APTIMA multitest (Orange label) tube using the pink shaft swab.
 
7.  Throat specimens from asymptomatic or symptomatic patients submitted in a APTIMA multitest (Orange label) tube using the pink shaft swab.

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 & Refrigerate​ 60 days​
APTIMA urine specimen transport tube​ (Yellow label Ambient & Refrigerate​ 30 days​
APTIMA multitest pink shaft swab (Orange label)​​ ​Ambient & 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 multitest (Orange label) tube
Transported improperly
Improper specimen source (Eye)​
Pre-pubescent children (<14 years of age) or medico-legal cases​
Female urethral swabs​
Overfilling/underfilling of the APTIMA urine transport tube​
​Midstream Urine Collections
​Rectal or throat specimens collected with blue swab in unisex (White label) tube
​Volume < 2 mL
​Volume > 30 mL
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield ​Monday - Friday
6-8 hours*
Transcription-Mediated Amplification (TMA) ​
*Testing performed once/day.
Sample must be received in the lab by 0400 to be tested same day. ​ ​ ​ ​
Test Information
This test cannot be utilized in medico-legal situations or prepubescent children (<14 years). In these circumstances, samples will be automatically forwarded to Mayo Laboratories using test code GCRNA. ​
Reference Range Information
Performing Location Reference Range
Marshfield​ ​Negative
Interpretation
Reported as Negative, Positive, Indeterminate, or Equivocal for 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
Synonyms/Keywords
​​Neisseria gonorrhoea, Gonorrhea, GC
Ordering Applications
Ordering Application Description
​Cerner
Neisseria Gonorrhoeae, Nucleic Acid Method (NAM)​

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 swab​
Male​Urethral Swab ​APTIMA Unisex blue shaft collection swab (White labeled tube) ​1 swab
​Vaginal Swab ​APTIMA multitest pink shaft collection swab (Orange labeled tube) ​1 swab
​Rectal SwabAPTIMA multitest pink shaft collection swab (Orange labeled tube)​​1 swab
​Throat SwabAPTIMA multitest pink shaft collection swab (Orange labeled tube)​1 swab​

​Thin Prep
​PreservCyt Thin Prep solution vial
(See Cytology, PAP, Thin Prep for collection requirements [see note #5 in the Collection Processing Instructions])




​1 vial​
Collection Processing
​This test will not be performed on prepubescent children or for medico-legal situations. 

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 2ml 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 a APTIMA Unisex (white label) collection tube. White shaft swab can be discarded; blue shaft swab is for specimen collection. Patient should not have urinated for at least 1 hour prior 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 instruction.

5. PreservCyt Thin Prep solution vial – see Cytology, PAP, Thin Prep for collection requirements.
 
6.  Rectal specimens from asymptomatic or symptomatic patients submitted in a APTIMA multitest (Orange label) tube using the pink shaft swab.
 
7.  Throat specimens from asymptomatic or symptomatic patients submitted in a APTIMA multitest (Orange label) tube using the pink shaft swab.

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 & Refrigerate​ 60 days​
APTIMA urine specimen transport tube​ (Yellow label Ambient & Refrigerate​ 30 days​
APTIMA multitest pink shaft swab (Orange label)​​ ​Ambient & 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 multitest (Orange label) tube
Transported improperly
Improper specimen source (Eye)​
Pre-pubescent children (<14 years of age) or medico-legal cases​
Female urethral swabs​
Overfilling/underfilling of the APTIMA urine transport tube​
​Midstream Urine Collections
​Rectal or throat specimens collected with blue swab in unisex (White label) tube
​Volume < 2 mL
​Volume > 30 mL
Useful For
Detection of Neisseria gonorrhoeae from urine and male urethral swab specimens, female endocervical swabs, Thin Prep samples, and vaginal swab specimens. Male and female rectal, throat swab specimens.
Reference Range Information
Performing Location Reference Range
Marshfield​ ​Negative
Interpretation
Reported as Negative, Positive, Indeterminate, or Equivocal for 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.
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Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Marshfield ​Monday - Friday
6-8 hours*
Transcription-Mediated Amplification (TMA) ​
*Testing performed once/day.
Sample must be received in the lab by 0400 to be tested same day. ​ ​ ​ ​
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
​87591
For most current information refer to the Marshfield Laboratory online reference manual.