General Information

UPHSM LIS Test #: 3504
Schedule: Monday - Friday
Testing Time: 1 Day
Testing Lab: UP Health System-Marquette

Specimen Info
Only 1 specimen type required, unless otherwise specified

Tube Type: See Collection Notes
Collection Info:
1. Patient should not have urinated for at least one hour prior to collection.
2. Patient should collect the first 15-60 mL of voided urine in a sterile leak-proof container. Collection of larger volumes of urine may reduce test sensitivity.
3. Urine samples must be transferred into the Cobas© PCR media tube using the provided disposable pipette.  The correct volume of urine has been added when the fluid level is between the two black lines on the tube label.  Tightly recap and invert 5 times to mix.
Note:  If the urine specimen cannot be transferred immediately, it can be stored at 2 - 30 ° C for up to 24 hrs.
4. Urine specimens in Cobas© PCR media are stable at 2 - 30 ° C for up to 1 year.

Female Endocervical and Vaginal Swabs
Note:  Male urethral swabs are not acceptable for testing.
Note:  Culture is the only recommended procedure for diagnosing chlamydial or N. gonorrhoeae infection in cases of suspected child abuse.
1.  Collection instructions are located on the Cobas© PCR Female swab sample kit.
2. Use the WOVEN cleaning swab to remove excess mucus from the cervical os and surrounding mucosa.  DISCARD WOVEN SWAB AFTER USE.
3.  To collect the specimen, use the FLOCKED swab.
4.  When breaking swab into the collection tube, break along the visible dark line on the swab shaft.
5.  Female endocervical and vaginal swabs in the Cobas© PCR Female swab and sample kit are stable at 2 - 30 ° C for up to 12 months.

Cervical Specimens in PreservCyt©
1.  Cervical specimens collected in PreservCyt© solution may be stored at 2 - 30 ° C for up to 12 months.
2.  Aliquots (≥to 1 mL) of cervical specimen collected in PreservCyt© may be stored in 13 mL round-based Sarstedt© tubes for up to 4 weeks at 2 - 30 ° C.  A minimum of 4 mL should be submitted for testing.
3.  The Cobas© CT/NG v2.0 test is validated to test cervical specimens collected in PreservCyt© solution either prior to cytology processing or after processing with the Thin Prep T2000© Processor only.  It is not validated for testing after cytology processing with the use of other cell processors.  Testing after processing with other devices may lead to false negative, false positive and/or invalid results.
4. When aliquotting specimens from primary containers into 13 mL, round-based Sarstedt© tubes, use pipettors with aerosol-barrier or positive displacement tips to handle specimens.

Specimen Acceptability


The specimen should ONLY CONTAIN THE FLOCKED SWAB.  The specimen will be rejected if the tube contains no swab or 2 swabs.


Cobas© CT/NG v2.0 PCR

Clinical Utilities

Detection of Neisseria gonorrhoeae in clinical samples.

CPT Codes


* The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding
is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Reference Range