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Test Code LAB3854 Chlamydia trachomatis and Neisseria gonorrhoeae, Miscellaneous Sites, Nucleic Acid Amplification, Varies

Important Note

This test should be used for the following collection site: eye.

 

Note: For dirty catch urine, vaginal, penile, urethral, endocervial, throat, or rectal site collections, use Chlam trachomatis and GC Aptima UW PCR (LAB2393). For all other specimens, use the in-house Chlam trachomatis and N. gonorrhoeae PCR (LAB2394).

Additional Codes

CTGC, Eye

Useful For

Detecting Chlamydia trachomatis and Neisseria gonorrhoeae in non-US Food and Drug Administration-approved specimen types

 

This test is not intended for use in medico-legal applications.

 

This test is not useful for the detection of Chlamydia pneumoniae or other Chlamydia species.

Profile Information

Test ID Reporting Name Available Separately Always Performed
MCRNA C. trach, Misc, Amplified RNA Yes Yes
MGRNA N. gonorr, Misc, Amplified RNA Yes Yes

Method Name

Transcription Mediated Amplification

Reporting Name

Misc C trach/N gonor Amplified RNA
Seattle Children's Hospital Note:

SCH Clinical System Name: Chlam trachomatis and N. gonorrhoeae, Eye Swab

Specimen Type

Varies
Seattle Children's Hospital Note:

This test should be used for the following collection site: eye.

 

Note: For dirty catch urine, vaginal, penile, urethral, endocervial, throat, or rectal site collections, use Chlam trachomatis and GC Aptima UW PCR (LAB2393). For all other specimens, use the in-house Chlam trachomatis and N. gonorrhoeae PCR (LAB2394).


Ordering Guidance


This test is used for specimens that are not US Food and Drug Administration (FDA) approved for this assay. Acceptable non-FDA-approved specimen types are ocular swabs, and peritoneal fluid.

 

For FDA-approved specimen types, order CGRNA / Chlamydia trachomatis and Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies.



Necessary Information


Specimen source is required.



Specimen Required


Submit only 1 of the following specimens:

 

Specimen Type: Ocular (corneal/conjunctiva)

Supplies:

Aptima Unisex Swab Collection Kit (T583)

Aptima Multitest Swab Collection Kit (T584)

Container/Tube: Aptima Multitest Swab or Aptima Unisex Swab

Specimen Volume: Swab

Collection Instructions:

1. Swab site using Aptima Multitest Swab or Aptima Unisex Swab. Specimens must be collected using either one of these Aptima swabs.

Note: The white swab provided within the collection kit is a cleaning swab and should not be used for collection. Discard the white cleaning swab.

2. Place collection swab in transport tube provided with the collection kit. Snap off swab at score line so swab fits into closed tube.

3. Cap tube securely and label tube with patient's entire name and collection date and time.

4. Maintain specimen at 2 to 30° C (refrigerate temperature is preferred), transport within 60 days of collection.

 

Specimen Type: Peritoneal fluid (pelvic wash, cul-de-sac fluid)

Supplies: Aptima ThinPrep Transport Tube (T652)

Container/Tube: Aptima specimen transfer tube

Specimen Volume: 1 mL

Collection Instructions:

1. Transfer 1mL of specimen into the Aptima specimen transfer tube within 24 hours of collection.

2. Cap tube securely and label tube with patient's entire name and collection date and time.

3. Maintain specimen at 2 to 30° C (refrigerate temperature is preferred), transport within 30 days of collection.


Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) APTIMA VIAL
  Ambient  APTIMA VIAL
  Frozen  APTIMA VIAL

Reject Due To

  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Reference Values

Negative

Method Description

The Hologic Aptima Combo 2 Assay combines the technologies of target capture, transcription-mediated amplification, and dual kinetic assay. The detection of the ribosomal RNA amplification product sequences (amplicon) is achieved using nucleic acid hybridization. Single-stranded chemiluminescent DNA probes are labeled and combined with amplicon to form stable RNA:DNA hybrids. Light emitted from the labeled RNA:DNA hybrids is measured as photon signals in a luminometer.(Package insert: APTIMA Combo 2 Assay, 20535-001. Hologic, Inc; Rev. 004, 08/2021)

Day(s) Performed

Monday through Sunday

Report Available

1 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87491 - Chlamydia trachomatis

87591 - Neisseria gonorrhoeae

87801 - If appropriate for government payers

LOINC Code Information

Test ID Test Order Name Order LOINC Value
MCTGC Misc C trach/N gonor Amplified RNA 64017-7

 

Result ID Test Result Name Result LOINC Value
SRC11 SOURCE: 31208-2
SRC22 SOURCE: 31208-2
34507 C. trach, Misc, Amplified RNA 43304-5
34508 N. gonorr, Misc, Amplified RNA 43305-2

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.