GC/Chlamydia by Amplified DNA Probe

Message
This DNA probe method is FDA approved for patients older than 10 years. If performed on younger patients, a disclaimer will be included with the result.


Test Code
PNEUP


Alias/See Also
GC, Chlamydia, GCCH, GC/Chlamydia by Amplified DNA Probe, GONOR, CHLAM


CPT Codes
87491, 87591

Includes
  • CHLAM:  Chlamydia by amplified DNA
  • GONOR:  GC by amplified DNA


Preferred Specimen
  • GENPROBE Aptima Unisex Swab Collection KIT for endocervical and male urethral specimens
  • GENPROBE Aptima Vaginal Swab Specimen Collection Kit
  • GENPROBE Aptima Urine Collection KIT for Male and Female Urine specimens
  • NOTE:  CRMC Emergency Room Specimens-Use the Xpert Collections Kits/Instructions.
  • NOTE:  CCMC In-House Testing Specimen-refer to information below.
Acceptable Specimens:  Clinician collected endocervical swabs, vaginal swabs, male urethral swabs, rectal swabs, pharyngeal (throat) swabs, Female urines, male urines.
NOTES:
  • Urine collections should be from a "first catch" collection (not a clean catch).
  • Urines from catheter collections are NOT acceptable.
  • Swabs on patients <15 years are forwarded to reference laboratory.

 


Instructions
GenProbe APTIMA Unisex Swab Collection System
GenProbe APTIMA Vaginal Swab Collection System

                       
  1. FEMALE ENDOCERVICAL Swab Specimen collection instructions:
    • Remove excess mucus from the cervical os and surrounding mucosa using the larger swab (white shaft). Discard that swab. Do NOT place this into the transport media tube.
    • Insert the specimen collection swab (blue shaft) into the endocervical canal. Gently rotate the swab clockwise for 10-30 seconds.
    • Withdraw the swab carefully-avoid contact with the vaginal mucosa.
    • Remove the cap from the transport tube and immediately place the specimen collection swab into the transport media.
    • Carefully break the swab shaft against the side of the transport tube. Discard the top portion of the shaft. Use care to avoid splashing of contents.
    • Re-Cap the transport tube tightly.
    • Label with patient information.
    • Forward to laboratory for testing.
    • GenProbe Aptima Vaginal Swab Specimen Collection Kit:   After Collection Storage:  Room or refrigerator temperature (2-300C).  Test within 60 days of collection.
  1. FEMALE VAGINAL Swab Specimen collection instructions:
    • Partially peel open the swab package. 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 Swab Specimen Collection Kit.
    • Remove the swab.
    • Hold the swab, placing the thumb and forefinger in the middle of the swab shaft.
    • Carefully insert the swab into the vagina about two inches past the introitus and gently rotate the swab for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab.
    • Withdraw the swab without touching the skin.
    • 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 Swab Specimen Collection Kit.
    • Immediately place the swab into the transport tube so that the tip of the swab is visible below the tube label.
    • Carefully break the swab shaft against the side of the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Swab Specimen Collection Kit.
    • Tightly screw the cap onto the tube.
    • Label with patient specific information.
    • GenProbe Aptima Vaginal Swab Specimen Collection Kit:   After Collection Storage:  Room or refrigerator temperature (2-300C).  Test within 60 days of collection.
  2. MALE URETHRAL Swab Specimen collection instructions:
    • The patient should not have urinated for at least 1 hour prior to specimen collection.
    • Insert the specimen collection swab (blue shaft) 2-4 cm into the urethra.
    • Gently rotate the swab clockwise for 2-3 seconds in the urethra. Withdraw the swab carefully.
    • Remove the cap from the transport tube and immediately place the specimen collection swab into the transport media.
    • Carefully break the swab shaft against the side of the transport tube. Discard the top portion of the shaft. Use care to avoid splashing of contents.
    • Re-Cap the transport tube tightly.
    • Label with patient information.
    • Forward to laboratory for testing
    • GenProbe Aptima Unisex Collection Kit:  After Collection Storage:  Room or refrigerator temperature (2-300C).  Test within 60 days of collection.
GenProbe APTIMA Urine Specimen Collection Kit:
                              
  • Male or Female Urine specimen collection instructions:
    • The patient should not have urinated for at least one hour prior to specimen collection. NOTE: Catheter urine specimens are not acceptable for this test.
    • 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 specimen dilution that may reduce test sensitivity.
    • Female patients should not cleanse the labial area prior to providing the specimen.
    • 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 transport tube label.
    • Re-cap the urine specimen transport tube tightly.
    • Label with patient specific information
    • Forward to laboratory for testing.
    • GenProbe Aptima Urine Collection Kit:      After Collection Storage:  Room or refrigerator temperature (2-300C).  Test within 30 days of collection.  If longer storage is required, freeze at -20 to -70 degrees C up to 90 days.

CRMC Emergency Room Specimens:
Vaginal/Endocervical SpecimensCollect using the Xpert Vaginal/Endocervical Collection Kit.
  • Transport to the laboratory at 2 °C to 30 °C.
  • Stable up to 60 days at 2 °C to 30 °C .
                                      
 
First Catch Male or Female Urine Specimen Collection instructions:
  • The patient should not have urinated for at least one hour prior to specimen collection. NOTE: Catheter urine specimens are not acceptable for this test.
  • 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.
  • Female patients should not cleanse the labial area prior to providing the specimen.Male patients should not cleanse the tip of the penis before collecting.
     
  • Specimen Processing-Option 1:Transport urine collection cup to microbiology immediately. Stable up to 8 days when stored/shipped at 4 °C.
  • Specimen Processing-Option 2:  Transfer 7 mL of urine into the urine specimen transport tube using the disposable pipette provided.  Re-cap the urine specimen transport tube tightly.  Label with patient specific information.  Forward to laboratory for testing.
    • Female urine:
      • Stable for 24 hours at room temperature
      • Stable for 45 days at refrigerator temperature
    • Male urine
      • Stable for 3 days at room temperature
      • Stable for 45 days at refrigerator temperature
                                                         


CCMC:  In House Testing Specimens:
Vaginal/Endocervical Samples for patients >14 years of age:  Collect using the Xpert Vaginal/Endocervical Collection Kit. (Available in lab)
  • Transport to the laboratory at 2 °C to 30 °C.
  • Stable up to 60 days at 2 °C to 30 °C.
                                      
First Catch Male or Female Urine Specimen Collection instructions:
  • The patient should not have urinated for at least one hour prior to specimen collection. NOTE: Catheter urine specimens are not acceptable for this test.
  • 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.
  • Female patients should not cleanse the labial area prior to providing the specimen. Male patients should not cleanse the tip of the penis before collecting.
     
  • Specimen Processing:  Transfer 12 mL of urine (7 mL minimum) into 2 red/clear top urine tubes using the blue vacutainer urine cup. Label both tubes with patient specific information.  Forward to laboratory for testing.
  •                     
  • Lab Processing: Transfer 7 mL of urine into the urine specimen transport tube using the disposable pipette provided. 
    •  
         


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Catheter collected Urine specimens.
Clean Catch Urine Collected Specimens


Methodology
GenProbe
Cepheid

Reference Range
Chlamydia:  Negative
GC:              Negative


Clinical Significance
Refer to individual Tests  CHLAM/GNORR


Performing Laboratory
CRMC Microbiology Laboratory
CCMC Laboratory



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.