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Aptima® Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Assay

See Specimen Submission Instructions for test requisition, specimen labeling and specimen packaging requirements. 

Test Description

Aptima® Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) – 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 disease using the Panther® system as specified.

Indications

The assay may be used to test specimens from symptomatic and asymptomatic individuals.

Results from the Aptima Combo 2 assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.

Acceptable specimens

  • ThinPrep® Pap Test PreservCyt Solution* vial
  • Aptima® Unisex Swab (Endocervical or Male Urethral Source)
  • Aptima® Urine Collection (Male or Female Urine Specimens) – Fresh urine transferred to Aptima Urine Transfer Tube within 24 hours of collection
  • Aptima® Multitest Swab Specimen (Vaginal, Throat, and Rectal Swab Specimens)

Collection Procedure

  • ThinPrep® Pap Test PreservCyt Solution* vial collected with a Broom type device (Rovers Cervex® Brush, Wallach Papette®), or Endocervical Brush/Spatula
    • Gynecologic specimens collected using routine pap specimen collection technique. Collect gynecologic specimens in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer’s instructions.
  • Aptima® Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens
    • Endocervical swab Specimen Collection
      1. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft swab in the package with red printing). Discard this swab. Note: To remove excess mucus from the cervical os, a large-tipped swab (not provided) may be used.
      2. Insert the specimen collection swab (blue shaft swab in the package with the green printing) into the endocervical canal.
      3. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling.
      4. Withdraw the swab carefully; avoid any contact with the vaginal mucosa.
      5. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube.
      6. Carefully break the swab shaft against the side of the tube at the scoreline and discard the top portion of the swab shaft; use care to avoid splashing of contents.
      7. Re-cap the swab specimen transport tube tightly.
    • Male Urethral swab Specimens
      1. The patient should not have urinated for at least 1 hour prior to sample collection.
      2. Insert the specimen collection swab (blue shaft swab in the package with the green printing) 2 to 4 cm into the urethra.
      3. Gently rotate the swab clockwise for 2 to 3 seconds in the urethra to ensure adequate sampling.
      4. Withdraw the swab carefully.
      5. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube.
      6. Carefully break the swab shaft against the side of the tube at the scoreline and discard the top portion of the swab shaft; use care to avoid splashing of contents.
      7. Re-cap the swab specimen transport tube tightly.
  • Aptima Urine Collection (for Male and Female Urine Specimens)
    1. The patient should not have urinated for at least 1 hour prior to specimen collection.
    2. Direct patient to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in rRNA target dilution that may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen.
    3. Remove the cap and transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine specimen transport tube label.
    4. Re-cap the urine specimen transport tube tightly.
  • Aptima Multitest Swab Specimen Collection Kit for Vaginal, Throat, and Rectal Swab Specimens
    • Vaginal Swab Specimen Collection
      1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection Kit.
      2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
      3. Carefully insert the swab into the vagina about 2 inches (5 cm) past the introitus and gently rotate the swab clockwise for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab and then withdraw the swab without touching the skin
      4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
      5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
      6. Carefully break the swab shaft at the score line against the side of the tube.
      7. Immediately discard the top portion of the swab shaft.
      8. Tightly screw the cap onto the tube.
    • Penile Meatal Swab Specimen Collection
      1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection Kit.
      2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
      3. Roll the swab clockwise on the tip of the penis, outside the opening of the penis (hole through which urine is passed). It is not necessary to put the swab inside the opening of the penis. Make sure to roll the swab all the way around the opening of the penis to get the best sample. Ensure the swab does not touch any other area of the skin.
      4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
      5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
      6. Carefully break the swab shaft at the score line against the side of the tube.
      7. Immediately discard the top portion of the swab shaft.
      8. Tightly screw the cap onto the tube.
    • Lesion Swab Specimen Collection
      • Note: Do not use disinfectants or cleaners on the lesion before the specimen is collected.
      1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection kit.
      2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
      3. If needed, expose the base of the lesion to access fluid.
      4. Vigorously swab the base of the lesion to absorb fluid, being careful not to draw blood. Withdraw the swab without touching any other site outside the lesion.
      5. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection kit.
      6. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
      7. Carefully break the swab shaft at the score line against the side of the tube.
      8. Discard the top portion of the swab shaft.
      9. Tightly screw the cap onto the tube.
    • Rectal Swab Specimens Collection
      1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection Kit.
      2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
      3. Carefully insert the swab into the rectum about 1-2 inches (3-5 cm) past the anal margin and gently rotate the swab clockwise for 5 to 10 seconds. Withdraw the swab without touching the skin.
      4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
      5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
      6. Carefully break the swab shaft at the score line against the side of the tube.
      7. Immediately discard the top portion of the swab shaft.
      8. Tightly screw the cap onto the tube.
    • Throat Swab Specimens Collection
      1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection Kit.
      2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
      3. Carefully insert the swab into the throat ensuring contact with bilateral tonsils (if present) and the posterior pharyngeal wall, then withdraw the swab without touching the inside of the cheeks or tongue.
      4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
      5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
      6. Carefully break the swab shaft at the score line against the side of the tube.
      7. Immediately discard the top portion of the swab shaft.
      8. Tightly screw the cap onto the tube.

Stability

ThinPrep® collection vials are stable for 30 days at ambient temperatures for CT, GC testing.

Urogenital, extragenital (throat, rectal) Swab specimens must be testing within 60 days of collection if stored at ambient temperatures.

Fresh Urine Specimens must be transferred to an Aptima urine specimen transport tube with 24 hours of collection.

Reference Range

Test is reported as:

  1. CT Neg Presumed negative for CT rRNA.(Normal Reference value)
  2. CT Pos Positive for CT rRNA.
  3. CT Equiv Indeterminate, a new specimen should be collected.
  4. GC Neg Presumed negative for GC rRNA.(Normal Reference value)
  5. GC Pos Positive for GC rRNA.
  6. GC Equiv Indeterminate, a new specimen should be collected.
  7. Invalid Indeterminate, a new specimen should be collected

CPT Code

Neisseria gonorrhoeae (GC)               87491

Chlamydia trachomatis (CT)              87591

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