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)
Samples submitted on patients younger than 14 years of age.

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 

Roche Guide For Self-collection In A Clinical Setting

Storage/Transport Temperature

Sterile urine container: Refrigerated
Cobas transport tube: Room Temperature

Stability (from collection to initiation)

Sterile urine container:
Refrigerated: 24 hours
Frozen: > 24 hours

Cobas transport tube:
Room Temperature: 14 days

Ordering Recommendations

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. cobas® CT/NG has not been evaluated in patients younger than 14 years of age. cobas® CT/NG is not recommended for evaluation of suspected sexual abuse and for other medico-legal indications.

Performed

Monday - Friday; Once a day

Methodology

Real-time polymerase chain reaction (PCR)

Reported

1-3 days

Performing Lab

Molecular

Synonyms

  • CTNG PCR (Chlamydia and N. gonorrhoeae)
  • C. trachomatis PCR
  • C trachomatis Screen by PCR
  • Chlamydia trachomatis by PCR
  • GC Screen by PCR
  • Gonorrhoeae PCR
  • Neisseria gonorrhoeae (GC), PCR
  • 11677

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.

Additional Information: Carbomer Containing Products

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)
Samples submitted on patients younger than 14 years of age.

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 

Roche Guide For Self-collection In A Clinical Setting

Storage/Transport Temperature

Sterile urine container: Refrigerated
Cobas transport tube: Room Temperature

Stability (from collection to initiation)

Sterile urine container:
Refrigerated: 24 hours
Frozen: > 24 hours

Cobas transport tube:
Room Temperature: 14 days
Ordering

Ordering Recommendations

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. cobas® CT/NG has not been evaluated in patients younger than 14 years of age. cobas® CT/NG is not recommended for evaluation of suspected sexual abuse and for other medico-legal indications.

Performed

Monday - Friday; Once a day

Methodology

Real-time polymerase chain reaction (PCR)

Reported

1-3 days

Performing Lab

Molecular

Synonyms

  • CTNG PCR (Chlamydia and N. gonorrhoeae)
  • C. trachomatis PCR
  • C trachomatis Screen by PCR
  • Chlamydia trachomatis by PCR
  • GC Screen by PCR
  • Gonorrhoeae PCR
  • Neisseria gonorrhoeae (GC), PCR
  • 11677
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.

Additional Information: Carbomer Containing Products
Additional Information

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

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