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CT/GC, Trichomonas – APTIMA

Alternate Name: CTGC_TRICH_APT

SAL Code:

9550

Specimen Requirements:

Primary Tube:

APTIMA

Primary Substance:

BioMat

Rejection Criteria:

Swab transport tubes must contain exactly one Hologic-Provided collection swab. Specimens will be rejected if the tube contains no swab, more then one swab, a cleaning swab, or any swab not supplied by Hologic.

Clinical Info:

Chlamydiae are nonmotile, gram-negative, obligate intracellular bacteria. N. gonorrhoeae are non-motile, gram-negative diplococci. Chlamydia trachomatis and Neisseria gonorrhoeae infections are among the most frequently reported sexually transmitted infections worldwide. These infections are often asymptomatic but may lead to serious complications such as urethritis, cervicitis, pelvic inflammatory disease, epididymitis, infertility, and neonatal conjunctivitis or pneumonia if left untreated. Current Centers for Disease Control and Prevention guidelines recommend nucleic acid amplofication tests (NAATs) as the preferred method for detecting these organismis because of their superioe sensitivity and specifucity compared with traditional culture and antigen-based methods.

Additional Information:

Principle of the Test
Aptima Combo 2 Assay is a second-generation NAAT performed on the Panther System for the qualitative detection of ribosomal RNA (rRNA) from C. trachomatis and Neisseria gonorrhoeae. The assay uses three core technologies:
-Target Capture: Magnetic microparticles and capture oligomers isolate target rRNA from the specimen and remove substances that may inhibit amplification.
-Transcription-Mediated Amplification (TMA): Specific regions of CT 23S rRNA GC 16S rRNA are amplified through DNA intermediates.
-Dual Kinetic Assay (DKA): Chemiluminescent probes generate lightsignals measured as Relative Light Units (RLUs), and the kinetic pattern distinguishes CT from GC targets.
Results are reported qualitatively as Positive or Negative.

Sample Collection:

Specimen Collection
Vaginal Swab
Collect the specimen using the Aptima vaginal swab by contacting the lower third of the vaginal wall and rotating the swab for 10-30 seconds to absorb secretions. Immediatley place the swab into the transport tube, break the shaft at the scored breakpoint, and securely tighten the cup.

Test Limitations:

Test Limitation
- Testing must be performed by personal trained in the assay procedure.
- Accurate results depend on proper specimen collection, handling, and processing.
- A negative result does not exclude infection if ogranism levels are below the detection limit of ot collection was inadequate.
- The assay is qualitative only and does not provide organism quantity.
- Nucleic acid may remain detectable after treatment; therefore, the assay should not be used to assess treatment success or failure.
- Patient - collected vaginal swab are intended only for use in clinical setting and have not been validated for home collection.
- Performance has not been established in patients younger then 14 years of age.

Specimen Handling Instructions:

Specimen Handling and Storage
Urogenital swab specimens should be transported and stored at 2 C to 30 C and tested within 7 days after the receipt date.

Test Information:

Components:

Component Name CPT Loinc
Chlamydia Trachomatis - Neisseria Gonorrhoeae, Aptima -
T. vaginalis RNA, QL TMA 87661 46154-1