CT/NG (Chlamydia Trachomatis/Neisseria Gonorrhoeae) PCR Assay

Message

The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC in female urine specimens and clinician-collected female endocervical swab specimens in a clinical setting.

Test Code

12362020021

Alias/See Also

GC
Chlamydia
Gonorrhoeae
Chlamydia

Preferred Specimen

GUTHRIE CLINIC LAB: Specimen collected with an Cobast® Dual Swab specimen collection kit

Patient Preparation
The patient must not urinate for at least 1 hour prior. Patient must not cleanse the genital area prior to collection of specimen.

Other Acceptable Specimens

Specimen collected in sterile container

Instructions

URINE
Prior to sampling, the patient shoud not have urinated for at least one hour. Given that collection of larger volumes of urine may reduce test sensitivity, please direct patient to provide first-catch urine (approximately 10-50 mL of the initial urine stream) into a urine collection cup.

Immediately transfer urine into the Cobas Urine tube using the provided disposable pipette.
The correct voume of urine has been added when the fluid level is between the two black lines on the tube label.
Tightly re-cap the Cobas Urine tube.
Invert the tube 5 times to mix.
The specimen is now ready for transport.

PATIENT COLLECTED VAGINAL - Do Not pre-wet the swab in Cobas PCR Media before collection.

To collect the specimen, hold the large woven swab with the scoreline above your hand and insert the swab about 2 inches into the vaginal opening. Gently turn the swab about 30 seconds while rubbing the swab against the walls of the vagine. Withdraw the swab carefully. Do not let the swab touch any surface before placing it into the collection tube.
Remove the cap from the Cobas PCR Media tube and lower the swab specimen into the tune until the visible scoreline on the swab is aligned with the tube rim.
Carefully leverage the swab against the tube rim to break the swab shaft at the scoreline.
Tightly re-cap the Cobas PCR Media Tube. The specimen is now ready for transport. Discard the top portion of the swab.

ENDOCERVICAL - Do Not pre-wet the swab in Cobas PCR Media before collection.

Using the woven swab (large swab), remove excess mucus from the cervial os and surrounding mucosa. Discard swab after cleaning. NOTE: Cleaning the excess mucus from the cervical os is required to ensure an adequate sample is obtained for processing.
To collect the specimen, hold flocked swab (small swab) with the scoreline above your hand and insert into the endoervical canal. Gently rotate the swab 5 times in one direction in the endocervical canal. Do not over-rotate. Carefully withdraw the swab, avoiding any contact with the vaginal mucosa.
Remove the cap from the Cobas PCR Media Tube and lower the swab specimen into the tube until the visible scoreline on the swab shaft is aligned with the tube rim. The bud of the swab should not be submergered into liquid prior to breaking the shaft.
Carefully leverage the swab against the tube rim to break the swab shaft at the scoreline.
Tightly re-cap the Cobas PCR Media Tube. The specimen is now ready for trasnport. Discard the top portion of the swab.

OROPHARYNGEAL (THROAT) - If using the Cobas PCR Media Dual Sample Kit, discard the flocked swab (small swab), as it is not needed for this procedure. Use only the woven large swab. NOTE: Do Not pre-wet the swab in PCR Media before collection.

To collect the specimen, hold the woven large swab with the scoreline above your hand. Insert the swab into the mouth and collect the specimen from the bilateral posterior pharynx, both tonsils and the uvula. Withdraw the swab carefully. Do not let the swab touch and surface before placing it into thte collection tube.
Remove the cap from the Cobas PCR Media Tube and lower the swab specimen into the tube until the visible scoreline on the swab shaft is aligned with the tube rim. The tip of the swab should not be submergered into liquid prior to breaking the shaft.
Carefully leverage the swab against the tube rim to break the swab shaft at the scoreline.
Tightly re-cap the Cobas PCR Media Tube. The specimen is now ready for transport. Discard the top portion of the swab.

ANORECTAL (RECTAL) SWAB SPECIMEN COLLECTION - If using the cobas PCR Media Dual Sample Kit, discard the flocked swab (small swab), as it is not needed for this procedure. Use only the woven large swab. NOTE: Do Not pre-wet the swab in PCR Media before collection.

To collect the specimen, hold the woven large swab with the scoreline above your hand. Insert the swab into about 1-2 inches into the anal canal. Gently turn the swab in a clockwise direction for about 5-10 seconds while rubbing the swab against the walls of the rectum. Withdraw the swab carefully. If the swab is grossly contaminated with feces, discard and repeat the collection. Do not let the swab tuch and surface before placing it into thte collection tube.
Remove the cap from the Cobas PCR Media Tube and lower the swab specimen into the tube until the visible scoreline on the swab shaft is aligned with the tube rim. The tip of the swab should not be submergered into liquid prior to breaking the shaft.
Carefully leverage the swab against the tube rim to break the swab shaft at the scoreline.
Tightly re-cap the cobas PCR Media Tube. The specimen is now ready for transport. Discard the top portion of the swab.

Transport Temperature

Refrigerated

Specimen Stability

GUTHRIE CLINIC LAB - Refrigerated urine: 8 days; Vaginal, endocervial, pharynx, rectal: Room temperature/refrigerated: 60 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Improper specimen colletion, storage and transport
Highly soiled rectal swab specimens

Reference Range

Negative

Performing Laboratory
Guthrie Clinic Lab

The CPT Codes provided in this document 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 payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.