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Test Code GC-NAM Neisseria Gonorrhoeae, Nucleic Acid Method (NAM)

Useful For

Detection of Neisseria gonorrhoeae from urine, female endocervical swabs, Thin Prep samples, and vaginal swab specimens. Male and female rectal, throat swab specimens.

Synonyms/Keywords

Neisseria gonorrhoea, Gonorrhea, GC

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 multitest pink shaft collection swab (Orange labeled tube)     1 swab  
Vaginal Swab APTIMA multitest pink shaft collection swab (Orange labeled tube)     1 swab  
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
 
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 multitest (orange label) collection tube. 
  3. 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.
  4. PreservCyt Thin Prep solution vial see Cytology, PAP, Thin Prep for collection requirements.   
  5. Rectal specimens from asymptomatic or symptomatic patients submitted in a APTIMA multitest (Orange label) tube using the pink shaft swab.  
  6. Throat specimens from asymptomatic or symptomatic patients submitted in a APTIMA multitest (Orange label) tube using the pink shaft swab.

Collection Procedure Guides:


For more information on Specimen Collection Media/Swab, see Specimen Transport Pictorial.  

Specimen Stability Information

Specimen Type Temperature Time
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

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
Volume < 2 mL
Volume > 30 mL
Non-Aptima Swabs

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. 

Interpretations

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.

Reference Range Information

Performing Location Reference Range
Marshfield Negative

Marshfield Labs Performing Department

Marshfield Labs Molecular Pathology

Performing 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.

CPT Codes

CPT Modifier
(if needed)		 Quantity Description Comments
87591        

Outreach CPT Codes

CPT Modifier
(if needed)		 Quantity Description Comments
87591        

Ordering Applications

Ordering Application Description
Cerner Neisseria Gonorrhoeae, Nucleic Acid Method (NAM)