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CHLAMYDIA AND GONORRHOEAE BY AMPLIFIED DNA, BD Qx

Mnemonic

CT/GC BD: Combination, CT/BD: Chlamydia only, GC/BD: GC only

Synonym

BD Qx - Viper - Chlamydia - GC - Venereal disease - C. trachomatis - N. gonorrhoeae - BD ProbeTec - GC CT

Includes

C. trachomatis and N. gonorrhoeae

Guidelines

Chlamydia and GC may be ordered individually or in combination. For medical purposes, the diagnosis of chlamydiosis or gonorrhea via DNA detection is adequate and has effectively supplanted the culture. This method detects both C. trachomatis and N. gonorrhoeae from a single sample. It is approved for use in asymptomatic and symptomatic female patients for diagnosis of C. trachomatis and N. gonorrhoeae. In male patients it is approved for use in symptomatic diagnosis of N. gonorrhoeae and both symptomatic and asymptomatic diagnosis of C. trachomatis.

Specimen Collection Requirements

Patient Preparation

For urine specimens the patient should not have urinated for at least 1 hour before urine collection. Female patients should not cleanse the labial area before providing urine.

Collect

Liquid Based Cytology (LBC), Endocervical Swab, Vaginal Swab, Male Urethral Swab, Urine

Other rare specimen types, including: throat, rectal, eye, skin or other non-FDA approved specimen type, may be submitted for testing. Specimen must be submitted in the BD Swab collection container using the pink or blue swab provided in the collection kit.

All specimen types not FDA approved will be reported with the following disclaimer: Validation studies have NOT been performed for chlamydia or gonorrheae testing on (specimen type here) specimens with the BD Viper XTR System and performance characteristics of the test for this specimen type are therefore unknown. Interpret results with caution.

Handling

Liquid Based Cytology (LBC): Specimens collected using either endocervical brush or brush/spatula combination in a ThinPrep or SurePath vial per manufacturer's recommendation.
Female Endocervical or Male Urethral Swab: Collected with BD Specimen Collection Kits.
Urine: First catch urine 20-60 mL in a sterile, preservative free cup (not mid stream), transfer 2-3 mL to BD Urine Preservative Tube (UPT)
Vaginal Specimen Transport Swab: Collected with Vaginal Specimen Transport for the BD ProbeTec CT/GC Qx Amplified DNA Assays.

Minimum Volume

2.0 mL Urine in a UPT tube

Transport

Liquid Based Cytology specimens: Ambient temperature (18-26°C)
Endocervical/Urethral swabs and Urines (UPT): Refrigerated (2-8°C)
Vaginal Swabs: Ambient temperature (18-26°C), dry, in collection tube

Rejection Criteria

Urine, less than 2 mL; Urine not in UPT that is either refrigerated (2-8°C) and >24 hours, or at ambient temperature (>9°C) and >8 hours; cleaning swabs (with or without the collection swab); LBC specimens containing large gross particulates or semisolids; ThinPrep treated with Glacial Acetic acid

Stability

LBC (2-30°C): 30 days; Urethral or Endocervical Swab (2-30°C): 30 days; Vaginal Swab, dry (2-30°C): 14 days; UPT (2-30°C): 30 days

Testing Information

Performed

Mon - Fri and a single run on the weekend

Reported

24-72 hours

Method

Strand Displacement Amplification, BD Qx

Reference Values

Reference Values

Negative: Presumed negative for C. trachomatis and/or N. gonorrhoeae. A negative result does not preclude C. trachomatis and/or N. gonorrhoeae infection because results are dependent on adequate specimen collection, absence of inhibitors and sufficient DNA to be detected.
Positive: Positive for C. trachomatis and/or N. gonorrhoeae. C. trachomatis and/or N. gonorrhoeae organism viability and/or infectivity cannot be inferred since target DNA may persist in the absence of viable organisms.

Comments

Results are intended as an aid in the diagnosis of chlamydial and gonococcal urogenital disease and should be interpreted in conjunction with clinical findings.  Positive results in low prevalence populations should be interpreted carefully.

CPT Codes

87591, 87491

Last Updated: Monday, April 17, 2017 03:41:10 PM


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