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HelpTest Code GC DNA PCR GC DNA PCR
Department
Molecular
Specimen Type
Vaginal, Cervical or urine
Method
Cobas 4800 System RT-PCR
Container
Cobas collection kit or urine cup
Special Requirements
Do not use this test for eye, throat or rectal sources.
Standard Volume
N/A
Minimum Volume
4 mLs for urine
Pediatric Volume
N/A
Ship Temperature
Room Temp
Stability Room Temp
24 hours
CPT Code
87591
Days Test Set Up
Monday through Friday
Group Components
GC DNA
Clinical Information
Chlamydia and N. gonorrhea infections are the most common sexually transmitted diseases in the U.S. N. gonorrhea causes acute urethritis in males, which left untreated develops into epididymitis, prostatisis, and urethral sticture. In females, the primary site of infection is the encocervix. An important complication in females is the development of pelvic inflammatory disease.
Test Use
The Roche Cobas 4800 System Chlamydia and Gonorrhea assays use Real Time PCR (Polymerace Chain Reaction) technology for direct, qualitative detection of C. trachomatis and N. gonorrheae DNA in vaginal swabs or urine for females, and urine for male patients.
Cautions
Interfering substances include, but are not limited to thr presence of blood and bilirubin. Detection of N. gonorrhea is dependent on the number of organisms present and may be affected by specimen collection methods, patient factors (age, history of STD, presence of symptoms), stage of infection and/or infecting NG strain.
Interpretation
A positive result indicates the detection of N. gonorrheae plasmid DNA. Viability cannot be inferred. A negative result indicates no detection of N. gonorrheae dependent on adequate specimen collection, absence of inhibitors and sufficient DNA to be detected.