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Indiana University Health Molecular Pathology Laboratory Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Qualitative Asssay For in vitro diagnostic use CERNER ORDERABLE Chlamydia PCR, CHLAM PCR 3054 GC PCR 3058 STD Panel GC PCR + CHLAM PCR 7469 CPT CODE 87491, 87590 CLINICAL UTILITY The APTIMA Combo 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the automated instrumentation as specified. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens, and female and male urine specimens. IU Health Molecular Laboratory has conducted an in-house validation of rectal and throat swabs1. METHODOLOGY The GEN-PROBE APTIMA Combo 2 Assay is a second generation nucleic acid amplification test (NAAT) that utilizes target capture. Transcription-Mediated Amplification (TMA), and Dual Kinetic Assay (DKA) technologies to streamline specimen processing, amplify target rRNA, and detect amplicon, respectively. SPECIMENS APTIMA Unisex Swab Specimen Collection Kit (blue shaft only-endocervical, vaginal, urethral, rectal, throat) APTIMA Vaginal Swab Specimen Collection Kit (orange label) Urines in preservative free sterile container (must be received with 24 hours of collection) SPECIMEN STABILITY Store the swab in the swab specimen transport tube at 2ºC to 30ºC Urine samples in the collection container must be transported to the lab at 2ºC to 30ºC SHIPPING Transport and store the swab in the swab specimen transport tube at 2ºC to 30ºC Urine samples in the collection container must be transported to the lab at 2ºC to 30ºC CAUSES FOR REJECTION APTIMA Unisex Swab Specimens with white shaft swab or both swabs 1. Reference information can be found in the Indiana University Health Molecular Assay Procedures. Urine specimens >24 hours since collection Urines collected in Tiger Top Tubes Specimens collected in SurePath vials ASSAY RANGE Qualitative Results (CT Positive/Negative and GC Positive/Negative) TURNAROUND TIME 1-3 days 1. Reference information can be found in the Indiana University Health Molecular Assay Procedures.