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Chlamydia trachomatis/ Neisseria gonorrhoeae

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Test Description
  • Contact: Molecular Biology and Virology (319) 335-4279
  • Test Request Form: Community-Based Screening Services (CBSS) sites: CBSS Molecular STI,
    Non-CBSS sites: Viral and Bacterial PCR
  • SHL OpenELIS Code: 1315 - CBSS, 1023 - Non-CBSS
Nucleic acid amplification by TMA to detect Chlamydia trachomatis and/or Neisseria gonorrhoeae rRNA.
Performed Avg. Turnaround Time Method
Coralville, 8 a.m. - 5 p.m., M - F
1 - 3 business days rRNA Amplification by TMA (Transcription-Mediated Amplification)
Fee CPT Code(s)
$119.28 87491, 87591
Specimen Requirements
Specimen Type: Preferred Specimen Types: Vaginal Swabs from Aptima Collection Device. Other acceptable specimen types: Urine, Pharyngeal (Throat) Swabs, or Rectal Swabs.
Patient Preparation: For urine specimens, client should not have urinated for at least 1 hour prior to specimen collection. Vaginal specimens must be collected in a clinical setting. The specimen may be clinician or client (self)-collected. Self-collected vaginal specimens are an option for screening asymptomatic women. The instructions on this page are for self-collected swabs. Clients must read the Patient Collection Instructions before providing them with a collection kit. For clinician-collected specimens, the vaginal specimen should be collected before inserting a speculum if an exam is to occur.
Collection Instructions: Collect samples using Aptima Mult-test or urine collection devices.

Urine Specimen Collection (Male or Female): Client should not have urinated for at least 1 hour prior to specimen collection.
  1. Direct client to provide first-catch urine (approximately 20 to 30 ml of initial urine stream) into urine collection cup, free from any preservatives. Collection of larger volumes may result in specimen dilution that may reduce test sensitivity. Female clients should not cleanse labia area prior to providing specimen.
  2. Remove cap from urine specimen transport tube, and transfer 2 ml of urine into urine specimen transport tube using disposable pipette provided. The correct volume has been added when fluid level is between black fill lines on urine specimen transport tube label.
  3. Re-cap urine specimen transport tube tightly.
Vaginal Specimen Collection (Non-pregnant women 16 years of age and older): Specimen must be collected in a clinical setting. The specimen may be clinician or client (self)-collected. Self-collected vaginal specimens are an option for screening asymptomatic women. The following instructions are for self-collected swabs. Clients must read the Patient Collection Instructions before providing them with a collection kit. For clinician-collected specimens, the vaginal specimen should be collected before inserting a speculum if an exam is to occur.
  1. Wash hands before starting.
  2. Partially peel open swab package. Do not touch soft tip or lay swab down. If soft tip is touched, swab is laid down, or swab is dropped, request a new Aptima Multi-test Swab Specimen Collection Kit.
  3. Remove swab.
  4. Hold swab by placing thumb and forefinger in the middle of the swab shaft.
  5. Carefully insert swab into the inside opening of the vagina, about two inches and gently rotate swab for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab.
  6. Withdraw the swab without touching skin.
  7. While holding swab in the same hand, unscrew the tube cap. Do not spill tube contents. If tube contents spill, request a new collection kit.
  8. Immediately place swab into the transport tube so the tip of the swab is visible below the tube label. Carefully break swab shaft at the indicated black line against the top side of the tube.
  9. Re-cap swab specimen transport tube tightly.
Rectal Swabs:
  1. Using the Aptima Multi-test collection device swab, insert specimen collection swab into the rectum approximately 4-6 cm and rotate against rectal wall several times.
  2. Withdraw the swab carefully. Avoid fecal contamination and in case of gross contamination discard the swab and recollect.
  3. Remove cap from swab specimen transport tube and immediately place specimen collection swab into specimen transport tube.
  4. Carefully break swab shaft at score line; use care to avoid splashing contents. Re-cap swab specimen transport tube tightly.
Pharyngeal (Throat) Swabs:
  1. Using a tongue depressor if necessary and the Aptima Multi-test collection device swab, insert swab into the pharynx and rotate against any inflammation and around the tonsillar area.
  2. Have the patient say "ah" for access to the pharynx and avoid touching the tongue, teeth, cheeks, etc. with the swab.
  3. Withdraw the swab carefully, again avoiding touching anything in the oral cavity.
Shipping:
Specimens should be stored and shipped under the same conditions. Wrap specimen container in absorbent material and place inside a biohazard bag. Transport specimen at room temperature.
Temperature and Stability: Room Temperature; stable for 30 days (urine) and 60 days (swabs).
Rejection Criteria: Specimens will be rejected if received under these conditions:

Specimens received over 30°C. Specimens collected using anything other than Aptima collection kits or transport tubes.
Expected Results:
Chlamydia trachomatis rRNA: Positive, Negative, Equivocal, Invalid. Neisseria gonorrhoeae rRNA: Positive, Negative, Equivocal, Invalid.
Comments
SHL performs Chlamydia trachomatis and Neisseria gonorrhoeae screening using the Aptima Combo 2 Assay. Therapeutic failure or success cannot be determined with the APTIMA Combo 2 Assay since nucleic acid may persist following appropriate antimicrobial therapy.
Alternate Names
CT/GC; CT/NG
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State Hygienic Laboratory

General inquires
SHL Client Services
319-335-4500 or 1-800-421-IOWA (4692)
ask-shl@uiowa.edu

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