Specimen Types:
Swab of cervix, endocervical or vaginal
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
4.5 mL; 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. Collection Container Chart
Storage/Transport Temperature
Sterile urine container: Refrigerated
Cobas transport tube: Room Temperature
Cobas TV/MG 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 Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in male or female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical specimens, all collected in cobas PCR Media (Roche Molecular Systems, Inc.). This test is intended as an aid in the diagnosis of TV and MG infections in individuals suspected to have TV or MG infection. A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher sensitivity compared to endocervical swabs and urine. For males, urine is the preferred specimen type due to higher sensitivity.
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
87563
Test Code (Outreach Synonym)
11829
Catalog Code
10105091061
Collection
Collect
Specimen Types:
Swab of cervix, endocervical or vaginal
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
4.5 mL; 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. Collection Container Chart
Storage/Transport Temperature
Sterile urine container: Refrigerated
Cobas transport tube: Room Temperature
Cobas TV/MG 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 Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in male or female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical specimens, all collected in cobas PCR Media (Roche Molecular Systems, Inc.). This test is intended as an aid in the diagnosis of TV and MG infections in individuals suspected to have TV or MG infection. A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher sensitivity compared to endocervical swabs and urine. For males, urine is the preferred specimen type due to higher sensitivity.
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.
