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Test Code CTNGPC CT/NG by PCR, LAB4526

Performing Laboratory

St. Luke's Hospital Cedar Rapids

Specimen Requirements

Acceptable Specimens:

Endocervical or patient-collected vaginal swabs (female only)

First voided urine specimens (male or female)

 

Endocervical Swab:

Obtain Xpert CT/NG Vaginal/Endocervical Specimen Collection Kit from the laboratory and collect as follows:

1.  Remove excess mucus from cervical os and surrounding mucosa using the large individually wrapped

     cleaning swab.

2.  Insert second swab from collection kit into endocervical canal.

3.  Rotate swab for 10 to 30 seconds in endocervical canal to ensure adequate sampling.

4.  Withdraw swab carefully; avoid any contact with vaginal mucosa.

5.  Aseptically remove cap from tube, insert swab into Xpert CT/NG Vaginal/Endocervical Swab

     Transport Reagent tube, and break swab at score line.  Screw cap on securely.

6.  Maintain sterility and forward promptly at ambient temperature.  Specimen stability is 60 days at 2 to

     30°C.

Note:  Indicate specimen source on specimen container and in computer.

 

Patient –collected Vaginal Swab:

Obtain Xpert CT/NG Vaginal/Endocervical Specimen Collection Kit from the laboratory and collect as follows:

1.  Remove and discard the large individually wrapped cleaning swab.

2.  Using the swab from the pink-capped collection packet, instruct patient to carefully insert swab into vagina about 2 inches inside the opening of the vagina and gently rotate swab for 10 to 30 seconds.  Ensure the swab touches the walls of the vagina so that moisture is absorbed by the swab.

3.  Withdraw swab carefully.

4.  While holding the swab in the same hand, unscrew the cap from the Xpert CT/NG Swab Transport Reagent tube.

5.  Immediately place the swab into the transport reagent tube and break swab at score line.  Screw cap on securely.

6.  Invert or gently shake the tube 3-4 times.

7.  Label specimen and send to the care provider.

8.  Maintain sterility and forward promptly at ambient temperature.  Specimen stability is 60 days at 2 to 30°C.

Note:  Indicate specimen source on specimen container and in computer.

 

NOTE:  Male Genital Swab specimens are NOT an acceptable specimen for this method.

 

Urine collection:

1.  Patient should not have urinated for at least 1 hour prior to specimen collection.

2.  Do not cleanse urethral area prior to specimen collection.

3.  Patient should collect first portion of random voided urine (first part of stream) into a sterile, plastic, preservative-free container.

4.  Ensure that the urine is well mixed in the urine cup and transfer approximately 7 mL of urine into the Xpert CT/NG Transport Reagent tube using the disposable pipette provided within 24 hours of collection.  The correct volume of urine has been added when the fluid level reaches the dash line on the urine transport tube.  NOTE:  If the specimen is being sent to the lab within 24 hours, it can be sent in the original urine collection container.

5.  Transport and store urine specimen transport container at 2 to 30°C.  The preserved specimen is acceptable for 3 days at ambient temperature and 45 days at refrigerated temperature.

 

 

 

  

 

Reference Values

Negative

Day(s) Test Set Up

Monday through Sunday

Methodology

Polymerase Chain Reaction (PCR)/DNA Extraction/PCR Amplification/Hybridization using the Cepheid GeneXpert.

Used for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in male and female urine specimens and in female genital specimens. 

Test Classification and CPT Coding

87491 and 87591