CDOS

C. TRACHOMATIS AND N. GONORRHOEAE, NAAT

Test Code: LAB1376

CPT Code: 87591 001 87491 001

Test Link (Copy)

Synonyms

CT/NG (NAAT); GONORRHEA SCREEN, CT, Chlamydia and GC DNA Probe

Specimen Type

Cervix, Male urethral or Voided Urine

Alternate Specimen Type

None

Specimen Container

GeneXpert Swab Kit for cervical and urethral specimens or a Screw-cap sterile cup for urine (15-20 mL) specimens

Volume

Urine 15- 20 mls, not to exceed 60 mls.

Minimum Collection Volume

Urine 15 mls

Specimen Handling

Transport swabs at room temperature. Transport urine samples refrigerated.

Patient Prep

Cervix: Remove excess mucus from the cervical os with the large-tipped cleaning swab (contained in the female collection kit) and discard. Urine: Patient should not have urinated for at least 1 hour prior to specimen collection. Do not cleanse urethra

Collection Procedure

Cervix, after cleansing with large swab from kit and discarding Insert the Endocervial Specimen collection swab into the cervical canal and rotate for 15-30 seconds. Withdraw the swab carefuully, avoiding contact with the vaginal mucosa. Immediately place the cap/swab into the transport tube. Make sure the cap is tightly secured to the tube. Male Urethra: Insert the Male Urethral collection swab 2-4 cm into the urethra and rotate for 3-5 sec. Urine: Collect the first 15-20 mls. of the initial voided, NOT midstream, specimen.

Limitations

Blood >5% (v/v) can cause Inderminate (inhibitory) or false-negative in both urine and swab speicmens. The presence of highly pigmented substances in urine, such as bilirubin (10 mg/ml) and Phenazopyridine (10 mg/ml) may also cause Indeterminate or false-negative results. Leukocytes in excess of 250,000 cells/ml (mucoid swabs) may case Indterminate or false-negative results. This test cannot be used to assess therapeutic success or failure since nucleic acids may persist following antimicrobial therapy.

Unacceptable Conditions

Midstream Urine that is for UA and culture testing. Swabs that are not from the BD ProbeTec Collection Kits.

Methodology

DNA Amplification

Stability

Room Temperature: Swabs: 4-6 days at room temperature.; Refrigerated: Urine: 4-6 days refrigerated.

Test Includes

GC DNA Probe, Chlamydia DNA Probe

Schedule

Mon-Fri (Positive results are set up for confirmation on the next run)

Turn Around Time

1-3 days

Place of Service

Swedish/Edmonds Laboratory

Department

Microbiology

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