Specimen Types:
Swab of cervix, endocervical, vaginal, throat or rectal
Urine (first catch)
Container Types: Cobas swab transport tubes; Cobas urine transport tubes; Yellow-top urine tube
Preferred Draw Volume
>4.5mL in sterile container; Between the two black lines on the cobas urine tubes
Minimum Draw Volume
4.5mL; Above the bottom line on the cobas urine tube
Unacceptable Conditions
Cobas swab tubes with two swabs
No swab in cobas swab tubes
Male urethral and penile specimens in cobas tubes
Aptima collection tubes
Urine specimens in sterile container >24 hours since collection
Grey urine culture tubes
Insufficient urine volume (<4.5mL)
Collection Comments
Urine samples MUST BE RECEIVED WITHIN 24 HOURS OF COLLECTION in non-preservative container, room temperature or refrigerated. When collecting non-urine specimen with Cobas swab sample kit, use one swab for cleaning and the second for collection. Place ONLY THE COLLECTION SWAB in the Cobas tube. Cobas sample tubes are NOT acceptable for male urethral or penile sources, urine is suggested. Thin prep and SurePath samples are not acceptable.
See Collection Guide: Collection Container Chart
Storage/Transport Temperature
Sterile urine container: Refrigerated
Cobas transport tube: Room Temperature
Cobas® CT/NG for use on the cobas® 6800/8800 Systems is an automated, qualitative in vitro nucleic acid diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), and clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) swab specimens and anorectal swab specimens all collected in cobas® PCR Media (Roche Molecular Systems, Inc.) This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.
Performed
Monday - Friday; Once a day
Methodology
Real-time polymerase chain reaction (PCR)
Reported
1-3 days
Performing Lab
Molecular
Synonyms
11677
Neisseria gonorrhoeae (GC), PCR
Gonorrhoeae PCR
GC Screen by PCR
Chlamydia trachomatis by PCR
C trachomatis Screen by PCR
C. trachomatis PCR
CTNG PCR (Chlamydia and N. gonorrhoeae)
Reference Interval
Not Detected
Assay Limitation(s)
A negative test result does not exclude the possibility of infection because the test result may be affected by improper specimen collection or the number of organisms in the sample is below detectable limits.
Clinical Interpretation
Of the OTC and prescription products tested in urogenital specimens, Metronidazole Vaginal Gel, ReplensTM Long-Lasting Vaginal Moisturizer, RepHreshTM Odor Eliminating Vaginal Gel and RepHreshTM Clean Balance produced false negative or invalid results in at least one replicate of the samples tested. These products contain carbomer(s). Products containing carbomer(s) have been shown to generate false negative and invalid results.
CPT Codes
CT: 87491 and NG: 87591
CTNG: 87801
LOINC Codes
NAME
LOINC
Result
Neisseria gonorrhoeae (Gonorrhea) DNA
43305-2
Chlamydia trachomatis (Chlamydia) DNA
4993-2
Test Code (Outreach Synonym)
11677
Catalog Code
9350031657
Collection
Collect
Specimen Types:
Swab of cervix, endocervical, vaginal, throat or rectal
Urine (first catch)
Container Types: Cobas swab transport tubes; Cobas urine transport tubes; Yellow-top urine tube
Preferred Draw Volume
>4.5mL in sterile container; Between the two black lines on the cobas urine tubes
Minimum Draw Volume
4.5mL; Above the bottom line on the cobas urine tube
Unacceptable Conditions
Cobas swab tubes with two swabs
No swab in cobas swab tubes
Male urethral and penile specimens in cobas tubes
Aptima collection tubes
Urine specimens in sterile container >24 hours since collection
Grey urine culture tubes
Insufficient urine volume (<4.5mL)
Collection Comments
Urine samples MUST BE RECEIVED WITHIN 24 HOURS OF COLLECTION in non-preservative container, room temperature or refrigerated. When collecting non-urine specimen with Cobas swab sample kit, use one swab for cleaning and the second for collection. Place ONLY THE COLLECTION SWAB in the Cobas tube. Cobas sample tubes are NOT acceptable for male urethral or penile sources, urine is suggested. Thin prep and SurePath samples are not acceptable.
See Collection Guide: Collection Container Chart
Storage/Transport Temperature
Sterile urine container: Refrigerated
Cobas transport tube: Room Temperature
Cobas® CT/NG for use on the cobas® 6800/8800 Systems is an automated, qualitative in vitro nucleic acid diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), and clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) swab specimens and anorectal swab specimens all collected in cobas® PCR Media (Roche Molecular Systems, Inc.) This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.
Performed
Monday - Friday; Once a day
Methodology
Real-time polymerase chain reaction (PCR)
Reported
1-3 days
Performing Lab
Molecular
Synonyms
11677
Neisseria gonorrhoeae (GC), PCR
Gonorrhoeae PCR
GC Screen by PCR
Chlamydia trachomatis by PCR
C trachomatis Screen by PCR
C. trachomatis PCR
CTNG PCR (Chlamydia and N. gonorrhoeae)
Result Interpretation
Reference Interval
Not Detected
Assay Limitation(s)
A negative test result does not exclude the possibility of infection because the test result may be affected by improper specimen collection or the number of organisms in the sample is below detectable limits.
Clinical Interpretation
Of the OTC and prescription products tested in urogenital specimens, Metronidazole Vaginal Gel, ReplensTM Long-Lasting Vaginal Moisturizer, RepHreshTM Odor Eliminating Vaginal Gel and RepHreshTM Clean Balance produced false negative or invalid results in at least one replicate of the samples tested. These products contain carbomer(s). Products containing carbomer(s) have been shown to generate false negative and invalid results.
