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HelpTest Code CHLAMYDIA/GC DNA PCR CHLAMYDIA/GC DNA PCR
Additional Codes
LAB8639
Department
Molecular
Specimen Type
Vaginal swabs, endocervical swabs, rectal swabs, oropharyngeal swabs and urine.
Method
Roche Cobas 6800 System Real time PCR
Container
Cobas collection kit or urine cup.
Special Requirements
Do not use this test for eye sources.
Minimum Volume
5 mLs for urine
Ship Temperature
Room Temperature
Stability Room Temp
Samples may be stored at 2-30 °C for up to 12 months once the specimens have been stabilized in cobas PCR Media.
Neat urine is stable at 2-30 °C for up to 24 hours.
CPT Code
87491
Days Test Set Up
7 days a week
Group Components
Chlamydia trachomatis DNA PCR
GC DNA PCR
Collection Instructions
For patients less than 14 years of age, collect a minimum of 5 ml urine in a sterile container and send to the laboratory immediately. Patients less than 14 will automatically be ordered by Epic as Chlamydia Trachomatis and Neisseria Gonorrheae (CT/GC) Nucleic Acid Amplification Testing. Specimen must be aliquoted into the Aptima Urine Specimen Transport tube and sent to Viracor for testing.
For vaginal, oropharyngeal and rectal specimens: Please collect using the woven swab in the cobas PCR media dual swab sample kit. Please place only the woven swab in the collection container.
For endocervical specimens: Use the large woven polyester swab in the cobas® PCR Dual Swab Sample Kit to remove cervical secretions and discharge. Then, use the flocked swab to obtain the endocervical specimen. Please place only the flocked swab in the collection container.
For adult urine specimens: Please collect urine in a sterile container. A minimum of 5 mL of urine is required to fill the cobas® PCR urine sample container.
Clinical Information
Chlamydia and GC infections are the most common sexually transmitted bacterial diseases in the U.S. Chlamydia causes cervicits, rethritis, salpingitis, proctitis and endometritis in women and urethritis, epididymitis and proctitis in men. N. gonorrheae causes acute urethritis in males, which if left untreated may develop into epididymitis, prostatis, and urethral sticture. In females, the primary site of GC infection is the endocervix. An important complication of GC infection in females is the development of pelvic inflammatory disease.
Test Use
The Roche Cobas 6800 System uses RT-PCR (Real Time Polymerase Chain Reaction) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhea DNA in vaginal, rectal and oropharyngeal swabs, and in male and female urines.
Cautions
Interfering substances include, but are not limited to the presence of blood and billirubin. Detection of C.trachomatis and N. gonorrhoeae is dependent on the number of organisms present and may be affected by specimen collection methods, patient factors (age, history of STD, presence of symtoms), stage of infection and/or infecting CT and NG strains.
This test should not be used to determine therapeutic success as nucleic acids may be present after antimicrobial therapy.
Interpretation
A Positive result indicates the detection of C.trachomatis and/or N. gonorrheae plasmid DNA. Viability cannot be inferred. A Negative result indicates no detection of C.trachomatis and/or N.gonorrheae dependent on adequate specimen collection, absence of inhibitors and sufficient DNA to be detected.