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Division of Consolidated Laboratory Services

CHLAMYDIA TRACHOMATIS (CT) AND NEISSERIA GONORRHOEAE (GC) NUCLEIC ACID AMPLIFICATIONTEST (NAAT)

Laboratory: Molecular Detection and Characterization

Test Description: Nucleic Acid Amplification of Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (CT) with Tigris Aptima Combo 2 kit

Order Approval Required? yes

Specimen Type: Cervical (female), urethral (male), vaginal (female) swabs and urine (Unisex)

Collection Container: APTIMA Unisex swab collection kit, APTIMA Urine specimen collection kit, APTIMA Vaginal swab collection kit. All swabs and urine are submitted in APTIMA foil-top tubes

Optimal Volume: Urine tubes filled between black lines. Swab tubes prefilled with correct liquid volume by manufacturer

Collection Guidelines: Urine: Patient should not have urinated for 1 hour prior to collection. Provide 20-30ml first catch urine into urine collection cup. Transfer urine from cup to APTIMA tube until liquid level in tube is between black lines (approximately 2 ml) Swabs: Remove excess mucus from cervix with white cleaning swab if necessary. Insert swab into appropriate orifice and gently rotate for 10-30 seconds. Remove swab, add to collection tube, and break swab at score line. Recap collection tube containing broken swab.

Storage Container: Gen Probe Swab or Urine tube

Storage Instructions: Swab samples stored at 2 °C to 30 °C for 60 days or frozen at -20 °C to -70 °C for 12 months. Urine samples stored at 2 to 30 °C for 30 days or frozen at -20 °C to -70 °C for 12 months

Transportation Instructions: 2 to 30 °C

Test Methodology: Nucleic Acid Amplification Test

Additional Information: http://www.hologic.com/products/clinical-diagnostics-blood-screening/assays-and-tests/aptima-combo-2-ctng-assay

Causes For Rejection: Incorrect/inconsistent sample labeling of submission information. Sample received outside of holding time. Incorrect source or swab type. Vaginal swab not broken at score line. Incorrect urine level.

Possible Results: Positive, Negative, or Indeterminate for Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC)