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NUCLEIC ACID AMPLIFICATION (NAAT) TESTING FOR CHLAMYDIA & GONORRHEA

Patient samples are analyzed for the presence of chlamydia-specific DNA or Gonorrhea -specific DNA that is amplified. This testing is being offered to State clinics and various locations to obtain data for the STD program.

TESTS OFFERED

  • Urine, oral, rectal and urogenital specimen testing for Chlamydia
  • Urine oral, rectal and urogenital specimen testing for Gonorrhea

SAMPLE COLLECTION, HANDLING AND SHIPMENT

  1. All specimens must be obtained using the collection kit supplied by the current test system in use in the laboratory. Kits are obtained by contacting the laboratory.
  2. Specimens should be labeled with patient name and clinic or school name using the B barcodes printed from our Laboratory Information Management System (LIMS), and placed in biohazard bag for transport (only one urine specimen per bag).
  3. Complete the Test Requisition Form including patient history information and insurance information (include ICD-9 code and Medicaid number) or order directly in LIMS as you would normally submit orders for laboratory tests.
  4. Specimens and forms should be sent to the laboratory, preferably the same day of collection. (If using a lab drop site, be sure that specimens will be picked up within the acceptable time frame, some sites do not have daily pickups.
  5. Specimens can be kept in the refrigerator or at room temperature for 30 days.
  6. Urine collection- first void specimen:
    1. Ensure that the patient has not voided within the last hour prior to collection.
    2. Collect the first part of the urine stream, obtaining 15-20 cc of urine in a paper or disposable cup, allow the remainder of stream to go into the toilet. Use the pipette that is provided in the urine collection kit to transfer 2 cc to the urine tube provided in the kit. (This is different than urine collection for culture which requires clean-catch midstream in a sterile container.)
    3. Close the tube securely and label with patient's name, clinic or school name, and date of collection. Place in biohazard bag with requisition form if required and refrigerate immediately if transport is delayed.
    4. If an exam is required and other test collected: The order of testing for specimen collection should be GC culture/gram stain, Chlamydia/GC NAAT test, and last urine collection for males. Urine collection first for females followed by GC culture/gramstain, pap smear, and Chlamydia/GC NAAT swab. If using a cytobrush for pap smear, collect that last since blood may interfere with the testing. (Some sites are only doing urine Chlamydia testing and GC by culture.)
  7. Urogenital Swab Collection
    1. Remove excess mucous from the cervical os in females using the white cleaning swab provided. Discard this swab.
    2. Insert the blue shaft specimen collections swab into the endocervical canal in females (2 to 4 cm into the urethra in males) Gently rotate the swab clockwise for 10 -30 seconds.
    3. Remove cap from swab transport tube and immediately place the specimen swab into the transport tube. Carefully break the swab at the scoreline, using care not to splash contents.
    4. Recap the swab specimen tube tightly. Label with patient name, date, and agency.
  8. Oral swab specimens
    1. Use the Aptima Unisex specimen collction swab (blue shaft swab in the package with green printing) to rub the posterior pharynx and tonsilar areas. Do not use the large white shafted swab. Discard this swab.
    2. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube.
    3. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents.
    4. Recap the swab specimen transport tube tightly.
  9. Rectal swab specimens
    1. Insert the Aptima Unisex specimen collection swab (blue shaft swab in the package with the green printing) 2 to 4 cm into the rectum and rotate to sample the mucosal surfaces. Do not use the large white shafted swab. Discard this swab.
    2. Withdraw the swab carefully.Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube.
    3. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents.
    4. Recap the swab specimen transport tube tightly.

RESULTS

Results are available within 72 hrs of receipt in laboratory. Final reports are available in LIMS as they are resulted. This test is specific for the DNA of these microorganisms and can detect them whether they are alive or dead, thus retesting should only be performed after 3 weeks from the start of treatment.

REJECTION


Samples will be rejected if they are:

  • Unlabeled specimens or those with discrepancies beween specimen and requisition forms - All specimens MUST have a unique patient identifier B barcode from LIMS.
  • Insufficient in Quantity - No specimen received, no specimen in container, or insufficient specimen to perform testing. Specimens received with no orders or requisition forms.
  • Improperly Preserved - Specimens must be refrigerated or stored at room temp for 30 days as defined by the laboratory. Tubes have collection media in the container that must be maintained in the tube with the swab. Expired transport containers, specimens received after prolonged delay or inappropriate transport conditions.
  • Damaged - Specimen leaked or broken in transit, dry specimens, or in fixative or other additive.
  • Wrong swab - the collection kit has a white cleaning swab and blue collection swab, only the blue swab can be used for testing. Samples submitted in bacterial culturettes, multiple swabs, white cleaning swab, wrong transport tube, or other collection containers or swabs.
  • Overfilled or Underfilled Urines- The yellow top tubes have a window where the urine volume should be filled to; those over or under this level will be rejected.

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Last Updated: Friday September 02 2011
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