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Test Code M15 Chlamydia/GC PCR, Swab

Important Note

Assay interference may be observed in the presence of blood or mucin with vaginal/endocervical specimens.

The Xpert CT/NG Assay provides qualitative results. No correlation can be drawn between the magnitude of the Ct value and the number of cells in an infected sample.

Xpert CT/NG Assay performance has not been evaluated in patients less than 14 years of age.

Xpert CT/NG Assay performance has not been evaluated in pregnant women, or in patients with a history of hysterectomy.

The Xpert CT/NG Assay has not been evaluated with patients who are currently being treated with antimicrobial agents active against CT or NG.

A negative test result does not exclude the possibility of infection because test results may be affected by improper specimen collection, technical error, specimen mix-up, concurrent antibiotic therapy, or the number of organisms in the specimen which may be below the sensitivity of the tests.

The Xpert CT/NG Assay should not be used for the evaluation of suspected sexual abuse or for other medico-legal indications. Additional testing is recommended in any circumstance when false positive or false negative results could lead to adverse medical, social, or psychological consequences.

Additional Codes

ALAB: CTGCS

PowerChart: Chlamydia/GC PCR

MA Cerner: Chlamydia/GC rPCR-Swab

Test Method

Polymerase Chain Reaction (PCR); Cepheid, GeneXpert

Specimen Requirement

Vaginal, endocervical,rectal, or pharyngeal swab collected using Xpert Swab Collection Device (Cepheid #SWAB/G-50) is required.

Additional Specimen Collection Information

Physician-Collected Endocervical Swab

    

Collection Instructions:

  1. Obtain an Xpert Swab Collection Kit.
  2. Remove excess mucus from the cervix and surrounding area using the large individually wrapped cleaning swab.
  3. Open the package that contains the pink-capped Xpert Swab Transport Reagent tube and individually wrapped collection swab. Set the tube aside. Do not expose swab to Xpert CT/NG Swab Transport Reagent prior to collection.
  4. Open the collection swab wrapper by peeling open the top of the wrapper.
  5. Hold the swab in your hand, placing your thumb and forefinger in the middle of the swab shaft.
  6. Insert the collection swab into the endocervical canal. Rotate the swab clockwise for 10-30 seconds in the endocervical canal. Withdraw the swab carefully.
  7. Unscrew the cap from the transport tube and immediately place the specimen collection swab into the transport reagent tube.
  8. Identifying the score-line, break the swab shaft against the side of the tube. Discard the top portion of the swab shaft.
  9. Recap the swab transport reagent tube and tighten the cap securely. Invert the tube 3-4 times to elute material from the swab.
  10. Label the plastic transport tube with the patient name, patient identification number, date and time of collection and the initials of the nurse who collected the specimen. 

Interfering Substances:
Interference may be observed in the presence of blood or mucin with endocervical specimens.

 

Storage:
Swab specimens in transport tubes can be stored at room temperature or refrigerated for up to 60 days.

 

Physician or Patient-Collected Vaginal Swab

 

Collection Instructions:

  1. Obtain an Xpert Swab Collection Kit. Swabs are not to be sent home with patients. They must be collected at the healthcare facility.
  2. Open the package that contains the pink-capped Xpert Swab Transport Reagent tube and individually wrapped collection swab. Set the tube aside. Do not expose swab to Xpert CT/NG Swab Transport Reagent prior to collection.
  3. Open the collection swab wrapper by peeling open the top of the wrapper. Remove the swab, taking care not to touch the tip or lay it down.
  4. Hold the swab in your hand, placing your thumb and forefinger in the middle of the swab shaft across the score-line.
  5. Carefully insert the swab into your vagina about two inches inside the opening of the vagina.
  6. Gently rotate the swab for 10-30 seconds. Ensure the swab touches the walls of the vagina so that moisture is absorbed onto the swab. Withdraw the swab and continue to hold it in your hand.
  7. Unscrew the cap from the transport tube and immediately place the specimen collection swab into the transport reagent tube.
  8. Identifying the score-line, break the swab shaft against the side of the tube. Discard the top portion of the swab shaft.
  9. Recap the swab transport reagent tube and tighten the cap securely.
  10. Patient collected specimen should be returned as instructed to your doctor, nurse, or care-provider. Specimen should  be  labeled the with the patient name, patient identification number, date and time of collection and the initials of employee who assisted with the collection of the specimen.

Interfering Substances:
Interference may be observed in the presence of blood or mucin with vaginal specimens.

 

Storage:
Swab specimens in transport tubes can be stored at room temperature or refrigerated for up to 60 days.

 

Clinician Collected Rectal Swab

 

Collection Instructions:

  1. Obtain an Xpert Swab Collection Kit.
  2. Discard the larger swab.
  3. Open the package that contains the pink-capped Xpert Swab Transport Reagent tube and individually wrapped collection swab. Set the tube aside. Do not expose swab to Xpert CT/NG Swab Transport Reagent prior to collection.
  4. Open the collection swab wrapper by peeling open the top of the wrapper.
  5. Hold the swab in your hand, placing your thumb and forefinger in the middle of the swab shaft.
  6. Carefully insert the swab approximately 1 cm beyond the anal sphincter (so that the fiber tip is no longer visible) and rotate gently. Withdraw the swab carefully.
  7. Unscrew the cap from the transport tube and immediately place the specimen collection swab into the transport reagent tube.
  8. Identifying the score-line, break the swab shaft against the side of the tube. Discard the top portion of the swab shaft.
  9. Recap the swab transport reagent tube and tighten the cap securely. Invert the tube 3-4 times to elute material from the swab.
  10. Label the plastic transport tube with the patient name, patient identification number, date and time of collection and the initials of the nurse who collected the specimen. 

Clinician Collected Pharyngeal Swab

 

Collection Instructions:

  1. Obtain an Xpert Swab Collection Kit.
  2. Discard the larger swab.
  3. Open the package that contains the pink-capped Xpert Swab Transport Reagent tube and individually wrapped collection swab. Set the tube aside. Do not expose swab to Xpert CT/NG Swab Transport Reagent prior to collection.
  4. Open the collection swab wrapper by peeling open the top of the wrapper.
  5. Hold the swab in your hand, placing your thumb and forefinger in the middle of the swab shaft.
  6. Instruct the patient to open mouth widely. Position tongue toward the bottom of the mouth. Swab areas of the pharynx (tonsil, posterior wall, uvula).
  7. Unscrew the cap from the transport tube and immediately place the specimen collection swab into the transport reagent tube.
  8. Identifying the score-line, break the swab shaft against the side of the tube. Discard the top portion of the swab shaft.
  9. Recap the swab transport reagent tube and tighten the cap securely. Invert the tube 3-4 times to elute material from the swab.
  10. Label the plastic transport tube with the patient name, patient identification number, date and time of collection and the initials of the nurse who collected the specimen. 

 

Performance

Testing performed Monday through Sunday.

Typically completed the same day the specimen arrives at the testing site.

Reference Values

Chlamydia trachomatis PCR: Negative

Neisseria gonorrhoeae PCR: Negative

 

All positive results are reported to the Iowa Department of Public Health.

CPT Code Information

87491 Detection Infectious Agents by Probe Techniques; Chlaydia trachomatis, amplified probe technique

87591 Detection Infectious Agents by Probe Techniques; Neisseria gonorrhoeae, amplified probe technique

Useful For

Detection of Chlamydia trachomatis or Neisseria gonorrhoeae.

LOINC Code Information

72828-7 Chlamydia trachomatis and Neisseria gonorrhoeae DNA panel - Unspecified specimen

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