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26172 GC (Gonorrheae) nucleic acid test

GC (Gonorrheae) nucleic acid test
Test Code: GC-NAT
Synonyms/Keywords

​Neisseria gonorrhoea, Gonorrhea, GC, Routine

Useful For

​*Available to Providers at MCHS-Neillsville location only.*  This test is useful for the detection of Neisseria gonorrhoeae from cervical, endocervical, vaginal swabs, and male and female urine specimens.

Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)		Pediatric Minimum Volume
(no repeat)
​Cervical, Endocervical, Vaginal​Xpert Vaginal/Endocervical Swab Kit​​1 swab​​
Urine​​Xpert Urine Kit​​20.0-30.0 mL​​
Collection Processing Instructions

This test will not be performed on children <14 years of age or for medico-legal situations.

1. Cervical, Endocervical, Vaginal specimens from asymptomatic or symptomatic patients submitted in an Xpert (red cap) collection tube. White swab is for cleaning; red scored shaft swab is for specimen collection. 
2. Male and female urine specimens transported in Xpert urine specimen (yellow cap) 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 first-catch urine to the fill line on the Xpert urine specimen transport tube. Urine samples must be transferred to an Xpert urine specimen transport tube within 24 hours of collection. 

Specimen Stability Information
Specimen TypeTemperatureTime
​Endocervical, Cervical, Vaginal ​​Ambient​60 days
​Refrigerate​60 days
​Urine​Refrigerate​8 days
Rejection Criteria
Specimens collected in devices other than the appropriate Xpert Collection Kits
​Children <14 yrs old
​Specimens transported improperly
​Midstream Urine Collections
​Overfilling/underfilling of the Xpert urine transport tube
​Improper Source (Throat, Eye, Rectal, Urethral)
Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation
Neillsville​​Monday through Sunday​24 hours​PCR/Probe Amplification
Test Information

This test uses a device labeled by the manufacturer as Investigational Use Only. The performance characteristics were determined by Marshfield Labs in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

For Medicare patients, an Advanced Beneficiary notice (ABN) is required; for Medicaid patients, a Noncovered Services Waiver is required, and for commerical payers, prior authorization should be obtained.
Reference Range Information
Performing LocationReference Range
​Neillsville​Not Detected
Interpretation

​Reported as Not Detected, Detected, or Indeterminate for Neisseria gonorrhoeae. Indeterminate results are due to unidentified interference. Repeat testing with a new specimen is recommended.

Outreach CPTs
CPTModifier
(if needed)		QuantityDescriptionComments
​87591​​​​
Synonyms/Keywords

​Neisseria gonorrhoea, Gonorrhea, GC, Routine

Ordering Applications
Ordering ApplicationDescription
​COM​GC (Gonorrheae) nucl acid test
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)		Pediatric Minimum Volume
(no repeat)
​Cervical, Endocervical, Vaginal​Xpert Vaginal/Endocervical Swab Kit​​1 swab​​
Urine​​Xpert Urine Kit​​20.0-30.0 mL​​
Collection Processing

This test will not be performed on children <14 years of age or for medico-legal situations.

1. Cervical, Endocervical, Vaginal specimens from asymptomatic or symptomatic patients submitted in an Xpert (red cap) collection tube. White swab is for cleaning; red scored shaft swab is for specimen collection. 
2. Male and female urine specimens transported in Xpert urine specimen (yellow cap) 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 first-catch urine to the fill line on the Xpert urine specimen transport tube. Urine samples must be transferred to an Xpert urine specimen transport tube within 24 hours of collection. 

Specimen Stability Information
Specimen TypeTemperatureTime
​Endocervical, Cervical, Vaginal ​​Ambient​60 days
​Refrigerate​60 days
​Urine​Refrigerate​8 days
Rejection Criteria
Specimens collected in devices other than the appropriate Xpert Collection Kits
​Children <14 yrs old
​Specimens transported improperly
​Midstream Urine Collections
​Overfilling/underfilling of the Xpert urine transport tube
​Improper Source (Throat, Eye, Rectal, Urethral)
Useful For

​*Available to Providers at MCHS-Neillsville location only.*  This test is useful for the detection of Neisseria gonorrhoeae from cervical, endocervical, vaginal swabs, and male and female urine specimens.

Reference Range Information
Performing LocationReference Range
​Neillsville​Not Detected
Interpretation

​Reported as Not Detected, Detected, or Indeterminate for Neisseria gonorrhoeae. Indeterminate results are due to unidentified interference. Repeat testing with a new specimen is recommended.

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation
Neillsville​​Monday through Sunday​24 hours​PCR/Probe Amplification
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)		QuantityDescriptionComments
​87591​​​​
For most current information refer to the Marshfield Laboratory online reference manual.