Test Name: LEUKORRHEA PANEL, RT-PCR, ONESWAB (MDL)
Test Code: 2191905
Alias: 121
CT/GC
LAB12040
OneSwab
Trich
CPT Code(s): 87591   87798   87491  
Test Includes:

105 Chlamydia trachomatis (Reflex to azithromycin resistance by Pyrosequencing)
167 Neisseria gonorrhoeae (Reflex to antibiotic resistance Molecular Analysis)
111 Trichomonas vaginalis (Reflex to metronidazole resistance)

129 Mycoplasma genitalium (Reflex to azithromycin & fluoroquinolone resistance)

Preferred Specimen: OneSwab
Container: OneSwab collection device
Alternate Container:

UroSwab

ThinPrep

Collection Instructions: Firmly, yet gently, obtain sample with the OneSwab, rotating it 360o for 10-30 seconds to ensure adequate sampling. When sampling a crusted over lesion, moisten the swab in sterile saline prior to taking the sample. Remove the swab and place into the vial. Snap off the shaft to fit completely in the vial. Be sure the swab fits into the vial prior to capping. Tightly cap the vial.
Transport Temperature: Room temperature
Stability:

Oneswab: Room temperature: up to 15 days

UroSwab: 4 days

ThinPrep: 9 days

Additional Information: Testing of UroSwab® specimens for females are applicable for adolescent females who are not candidates for pelvic exams
Schedule: TAT: Report available 1-3 days upon receipt of specimen at MDL 
Method: Real-Time, PCR
Performing Lab: Medical Diagnostic Laboratories, L.L.C. (MDL); #121
Clinical Significance:

Chlamydia trachomatisNeisseria gonorrhoeaeTrichomonas vaginalis, and Mycoplasma genitalium are the major causes of leukorrhea. C. trachomatis is the most common sexually transmitted bacterial agent. In women, C. trachomatis causes cervicitis, urethritis, endometritis, and salpingitis. Prolonged C. trachomatis infection may result in tubal scarring, infertility, and ectopic pregnancy. Neisseria gonorrhoeae is the causative agent of the sexually transmitted disease gonorrhea. In women, the most common symptom of N. gonorrhoeae infection is endocervical infection which, if left untreated, may develop into vulvovaginitis and pelvic inflammatory disease. As a protozoan parasite, Trichomonas vaginalis is the causative agent of the sexually transmitted disease trichomoniasis. T. vaginalis infection is the primary cause of vaginitis, cervicitis and urethritis in women. Routine clinical diagnosis usually depends on microscopic identification of the parasite in wet mount preparations, which are only 60% sensitive as compared to culture-positive women. The sensitivity and specificity of PCR testing for C. trachomatis and N. gonorrhoeae are superior to the HCII (probe-based) assay which has a sensitivity/specificity of 75% / 97%, and 90.8% / 99.3%, respectively.

Due to overlapping symptoms of gonorrhea, chlamydia, and trichomoniasis, It is important to test for M. genitalium especially given the difference in treatment options. Recent studies have shown that macrolide resistance to the M. genitalium primary antibiotic regimen (azithromycin), which highly correlates with treatment failure, ranges from 44% to 90% in the United States, Canada, Western Europe, and Australia. In the Sexually Transmitted Infections Treatment Guidelines, 2021, published by the Centers for Disease Control and Prevention (CDC), they state that ideally, Mycoplasma genitalium antibiotic resistance testing should be performed and used to guide therapy. In this assay, DNA is extracted from the specimen and subjected to PCR amplification.

 

 

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Updated 4/4/2024 KB

The CPT codes included in this publication are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are provided here for the convenience of our clients; however, correct coding often varies from one carrier to another, and HealthLab may bill specific carriers using codes other than those shown. Clients who bill for services should verify the code(s) with the applicable payor to confirm that their use is appropriate in each case.

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