Chlamydia/Gonorrhea by PCR


Abbrev Code:CTNGP   
Order Code:LAB7085Order Name:Chlamydia/Gonorrhea PCR
Synonyms:Chlamydia/Gono Amplified; LAB60003 (LHE); Chlamydia Trachomatis/Neisseria Gonorrhoeae by PCR
Methodology:Transcription-Mediated Amplification
The Hologic assays combine the technologies of target capture, transcription-mediated amplification and dual kinetic assay. The detection of ribosomal RNA amplification product sequences is achieved using nucleic acid hybridization. Single-stranded chemiluminescent DNA probes are labeled and combine with amplicon to form stable RNA:DNA hybrids. Light emitted from the hybrids is measured as photon signals in a luminometer.
CPT Codes: 87491 x1, 87591 x1
Test Includes:Testing is performed on genitourinary, urine, eye, throat, rectum specimens only.
Turnaround Time:Performed 7 days a week; results are reported within 2-3 days.
Associated Links:

IDDL (Microbiology/Virology) Collection Container Guidelines


Collection Instructions

Collection Instructions:
Specimen Type Instructions Container Alternate Container
Vaginal Swab Insert collection swab (pink shaft) into the vagina about 2 inches past the introitus and gently rotate for 10-30 seconds.
Place swab into transport tube provided in the collection kit. Snap off swab at score line so swab fits into closed tube. Discard the top portion of the swab shaft.
Cap securely and label with appropriate patient information.    		 Orange (Multitest) Aptima kit (Vaginal self-collect)
N/A
Urine Patient should not have urinated for at least 1 hour prior to specimen collection. Female patients should not cleanse the labial area prior to providing the specimens.
Patient should collect first 20-30 mL of random voided urine (first catch) into a sterile, plastic, preservative-free container. Note: Collection of a larger volume may reduce test sensitivity.
Transfer 2 mL of urine into the urine specimen transport tube using the disposable pipet provided within 24 hours of collection. The correct volume or urine has been added when the fluid level is between the black fill lines on the urine transport tube.
Cap securely and label with appropriate patient information.		 Yellow Aptima kit (Urine)
Sterile Container
Swab: Cervix, Endocervix Use large white cleaning swab (white) to remove excess mucus from endocervix and discard.
 
Insert collection swab (blue shaft) 1 to 1.5 cm into endocervical canal and rotate swab gently for 10-30 seconds. Avoid touching vaginal mucosa when removing swab.
 
Place collection swab into transport tube provided in the collection kit. Snap on swab at score line so swab fits into closed tube.
 
Cap securely and label with appropriate patient information.		 Purple Aptima kit (Unisex collection with blue swab)
N/A
Swab: Urethra (Males only) Patient should not have urinated for at least 1 hour prior to specimen collection.
 
With a rotating movement, insert swab (blue shaft) 2 to 4 cm into urethra.
 
Once inserted, rotate swab gently at least 1 rotation using sufficient pressure to ensure swab comes into contact with urethral surfaces. Allow swab to remain inserted 2-3 seconds.
 
Place swab into transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.
 
Cap securely and label with appropriate patient information.		 Purple (Unisex) Aptima kit
 N/A
 
Swab: Penile Meatal Specimen Roll the pink swab on the tip of the penis and outside the opening of the penis. It is not necessary to put the swab inside the opening of the penis.
 
Place swab into transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.
 
Cap securely and label with appropriate patient information.		 Orange (Multitest) Aptima kit
 N/A
Swab: Throat, Rectum, Eye Aptima Multitest Collection kit (pink swab):
  • Throat - ensure there is contact with the posterior pharyngeal wall. Avoid touching the inside of the cheeks and tongue.
  • Rectum- insert swab into the rectum about 1-2 inches and rotate clockwise for 5-10 seconds.
 
Aptima Unisex Collection kit (blue swab):
  • Throat - ensure there is contact with the posterior pharyngeal wall. Avoid touching the inside of the cheeks and tongue.
  • Rectum- insert swab into the rectum about 1-2 inches and rotate clockwise for 5-10 seconds.
  • Note: The white swab in the Unisex collection kit is a cleaning swab and should NOT be used for collection. Discard the white cleaning swab.
 
Place sample swab in transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.
 
Cap securely and label with appropriate patient information.		 Orange (Multitest) Aptima kit
Purple (Unisex) Aptima kit
Causes for Rejection:Follow manufacturer's collection instructions on the collection kit package.
The following specimens will not be tested:
  • Midstream and catheterized urine specimens
  • Overfilled or underfilled urine transport tubes
  • Urine in the grey top aliquoted tube (with preservative)
  • Transport tubes containing a large, white cleaning swab
  • Transport tubes containing more than 1 swab
  • Transport tubes with the absence of a collection swab
  • Transport tubes containing a swab not included in the collection kit
Note: Specimen source must be approved for the collection kit used. See collection instructions for suitable sources for each type of Aptima collection kit.
Contraindications:Per manufacturer's package insert, the performance of the vaginal swab specimen has not been evaluated in pregnant women or teenage women less than 16 years of age.


Processing and Shipping

Specimen Processing:Swab specimens: After collection, transport and store swab in the swab transport tube at 2°-30°C. Specimens must be assayed within 60 days of collection.

Urine specimens: After collection, transport processed urine specimens in the Aptima urine transport tube at 2°-30°C. Processed urine specimens must be assayed within 30 days of collection. Urine samples that are still in the primary collection container must be transported to the testing lab at 2°-30°C. Urine must be transferred to the Aptima urine specimen transport tube within 24 hours of collection.
Shipping Instructions:Swab specimens: After collection, transport and store swab in the swab transport tube at 2°-30°C. Specimens must be assayed within 60 days of collection.

Urine specimens: After collection, transport processed urine specimens in the Aptima urine transport tube at 2°-30°C. Processed urine specimens must be assayed within 30 days of collection. Urine samples that are still in the primary collection container must be transported to the testing lab at 2°-30°C. Urine must be transferred to the Aptima urine specimen transport tube within 24 hours of collection.
Specimens should be sent in individual bags to limit the possibility of cross-contamination,
Test Performed at or Referral Lab Infectious Diseases Diagnostic Laboratory   (UMMC East Bank)


Interpretive

Reference Range:Negative for Chlamydia trachomatis and Neisseria gonorrhea by PCR
Limitations:As is true for all urine test methods, a negative urine result for a female patient who is clinically suspected of having chlamydial or gonococcal infections does not rule out the presence of CT or GC in the urogenital tract. Testing of an endocervical specimen is recommended in such cases.


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