GONORRHOEAE BY AMPLIFIED DNA, BD QX

Mnemonic

GC/BD; GC/BD QX

Synonym

BD Qx - Viper - gonorrhea - N. gonorrhoeae - BD ProbeTec - GC - Nucleic Acid Amplification Test (NAT or NAAT)

Includes

N. gonorrhoeae

Guidelines

Gonorrhea may be ordered individually without CT. For medical purposes, the diagnosis of gonorrhea via DNA detection is adequate and has effectively supplanted the culture. This method detects N. gonorrhoeae. It is approved for use in asymptomatic and symptomatic female patients for diagnosis of N. gonorrhoeae. In male patients it is approved for use in both symptomatic and asymptomatic diagnosis of N. gonorrhoeae.

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 gonorrhoeae 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 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

Performed

6 days a week

Reported

24-72 hours

Method

Strand Displacement Amplification, BD Qx

Reference Values

Negative: Presumed negative for N. gonorrhoeae. A negative result does not preclude N. gonorrhoeae because results are dependent on adequate specimen collection, absence of inhibitors and sufficient DNA to be detected.
Positive: Positive for N. gonorrhoeae. 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

Gonorrhoeae by Amplified DNA, BD Qx

Specimen Collection Requirements

Testing Information

Reference Values