Urine-Chlamydia/Neisseria/M. genitalium/Trich PCR

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Important Note



This test has not been validated for patients <18 year old. Please contact the laboratory or collect with an Aptima swab if testing is needed for this age range.


Test Code
UCGMT


Alias/See Also
Epic: LAB14702


Includes
Neisseria gonorrhoeae
Chlamydia trachomatis
Trichomonas vaginalis
Mycoplasma genitalium



Preferred Specimen

Specimen Type: Urine
Collection Container: Urine COBAS media
Specimen Volume: 5.5 mL (sample volume must be between the two indicator lines on the tube)




Minimum Volume

5.5 mL




Instructions
  1. Prior to sampling, the patient should not have urinated for at least one hour.
  2. Direct patient to provide first-catch urine (approximately 10 to 50 mL of the initial urine stream) into a urine collection cup.
  3. Immediately transfer the urine into the COBAS® PCR Media tube using the provided disposable pipette.
  4. NOTE: If the urine specimen cannot be transferred immediately, it can be stored at 2°C to 30°C for up to 24 hours.
  5. The correct volume of urine has been added when the fluid level is between the two black lines on the tube label. Do not over or under fill.
  6. Tightly re-cap the cobas® PCR Media tube.
  7. Invert the tube 5 times to mix. The specimen is now ready for transport.


Transport Container
COBAS media vial


Specimen Stability

Room temperature: 1 month
Refrigerated: 1 month




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

Bloody specimens are unacceptable for testing




Methodology

Real-time polymerase chain reaction (PCR) 



Setup Schedule
Monday, Wednesday, Friday


Report Available

2-3 days




Limitations

A vaginal swab is the preferred specimen type for Mycoplasma genitalium testing in females due to higher sensitivity compared to endocervical swabs and urine. If the preferred specimen type is not used, further testing with the preferred specimen type may be indicated if M. genitalium infection is strongly suspected. Testing with this instrument is not available for patients <18 years old.
This test is not recommended for evaluation of suspected sexual abuse and for other medico-legal indication




Reference Range
Neisseria gonorrhoeae: Negative
Chlamydia trachomatis: Negative
Trichomonas vaginalis: Negative
Mycoplasma genitalium: Negative



Clinical Significance
Results depend on adequate specimen collection, absence of inhibitors, and sufficient DNA for detection.
This test should not be used to determine therapeutic success as nucleic acids may be present, and detected, after antimicrobial therapy.
A negative result does not necessarily rule out infection. Specimens containing mucus, gels, lubricants, or creams may give invalid or false negative results.



Performing Laboratory

Inova Laboratories

2832 Juniper Street

Fairfax, VA 22031




Last Updated: May 10, 2023
Last Review: N. Wolford, May 10, 2023


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.