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NUCLEIC ACID AMPLIFICATION TESTS FOR CHLAMYDIA, GONORRHEA AND TRICHOMONAS



METHOD — Hologic Panther


TESTS OFFERED

  • Clinician-collected endocervical, vaginal and male urethral swabs
  • Male and female urine specimens
  • Patient-collected vaginal swab specimens
  • Oral swabs – CT/GC only. Not appropriate specimen for Trichmonas vaginalis testing
  • Rectal swabs – CT/GC only. Not appropriate specimen for Trichmonas vaginalis testing

SAMPLE COLLECTION, HANDLING AND SHIPMENT

  1. All specimens must be obtained using the appropriate collection kit for each specimen source. There are three color-coded collection kits available from the DPHL warehouse. Store collection kits at Room temperature (15℃ – 30℃).

    Aptima® Urine Kit – for Urine specimens only (YELLOW)
    Aptima® Unisex Swab Kit – for Endocervical and Male Urethral Swab Specimens (PURPLE)
    Aptima® Multitest Swab Kit – for patient-collected vaginal swabs, oral swabs, and rectal swabs (ORANGE)

  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 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. Male and Female Urine Directions – Use Aptima Urine Collection Kit
    1. The patient should not have urinated for at least one hour prior to sampling.
    2. Direct patient to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a urine collection cup. Collection of larger volumes of urine may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen.
    3. 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 lines on the urine specimen transport tube label.
    4. Re-cap the urine specimen transport tube tightly. This is now known as the processed urine specimen.
  6. Endocervical Swab Directions – Use Aptima Unisex Swab Collection Kit
    1. Ensure that the patient has not voided within the last hour prior to collection.
    2. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft). Discard this swab. Note: To remove excess mucus from the cervical os, a large-tipped cleaning swab (not provided) may be used.
    3. Insert the specimen collection swab (blue shaft) into the endocervical canal.
    4. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling.
    5. Withdraw the swab carefully; avoid any contact with the vaginal mucosa.
    6. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube.
    7. Carefully break the swab shaft at the score line; use care to avoid splashing of contents.
    8. Re-cap the swap specimen transport tube tightly.

  7. Male Urethral Swab Directions – Use Aptima Unisex Swab Collection Kit
    1. The patient should not have urinated for at least one hour prior to sampling.
    2. Insert the specimen collection swab (blue shaft) 2 to 4 cm into the urethra.
    3. Gently rotate the swab clockwise for 2 to 3 seconds in the urethra to ensure adequate sampling
    4. Withdraw the swab carefully.
    5. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube.
    6. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube.
    7. Carefully break the swab shaft at the score line; use care to avoid splashing of contents.
    8. Re-cap the swap specimen transport tube tightly.

  8. Self-Penile Swab Collection Directions – Use Aptima Multitest Swab Collection Kit
    1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down.
    2. Hold swab in your hand, placing your thumb and forefinger in the middle of the swab shaft covering the score line (black line). Do not hold swab shaft below the score line (black line).
    3. Uncircumcised men will have to roll the foreskin down before starting collection. Hold the penis with your free hand (hand with no swab). Using your other hand (with the swab), roll the swab just at the tip or outside the opening to the penis. It is not necessary to put the swab deep inside the opening of the penis.
    4. While holding the swab in the same hand, unscrew the cap from the swab specimen transport tube, making sure not to spill any liquid. Immediately place the specimen collection swab into the transport tube.
    5. Carefully break the swab shaft at the score line; use care to avoid splashing of contents.
    6. Re-cap the swap specimen transport tube tightly.

  9. Self-Vaginal Swab Collection Directions – Use Aptima Multitest Swab Collection Kit
    1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down.
    2. Hold swab in your hand, placing your thumb and forefinger in the middle of the swab shaft covering the score line (black line). Do not hold swab shaft below the score line (black line).
    3. Carefully insert the swab into your vagina about 2 inches (5 cm) 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 and then withdraw the swab without touching the skin.
    4. While holding the swab in the same hand, unscrew the cap from the swab specimen transport tube, making sure not to spill any liquid. Immediately place the specimen collection swab into the transport tube.
    5. Carefully break the swab shaft at the score line; use care to avoid splashing of contents.
    6. Re-cap the swap specimen transport tube tightly.

  10. Self-Throat Swab Collection Directions – CT/GC testing only. Use Aptima Multitest Swab Collection Kit
    1. Wash hands with soap and water. Making sure not to touch the cotton tip, remove the swab from the wrapper.
    2. Hold swab in your hand and look into a mirror
    3. Open your mouth wide and wipe the swab around the tonsils on both sides of the throat several times. Do not touch the tongue or cheeks with the swab.
    4. Remove the cap from the swab specimen transport tube, making sure not to spill any liquid. Immediately place the specimen collection swab into the transport tube.
    5. Carefully break the swab shaft at the score line; use care to avoid splashing of contents.
    6. Re-cap the swap specimen transport tube tightly.

  11. Self-Rectal Swab Collection Directions – CT/GC testing only. Use Aptima Multitest Swab Specimen Collection Kit
    1. Wash hands with soap and water. Making sure not to touch the cotton tip, remove the swab from the wrapper.
    2. Put the swab 1 inch into the rectum and rotate for 5-10 seconds.
    3. Remove the cap from the swab specimen transport tube, making sure not to spill any liquid. Immediately place the specimen collection swab into the transport tube.
    4. Carefully break the swab shaft at the score line; use care to avoid splashing of contents.
    5. Re-cap the swap specimen transport tube tightly.
    6. Wash hands with soap and water.

    SPECIMEN STABILITY AND TRANSPORT

    1. Urine – After collection, transport and store urine specimen transport tube at 2℃ to 30℃ until tested. Specimens must be assayed with the APTIMA Assay for CT and/or GC within 30 days of collection. If longer storage is needed, freeze at -20℃ to -70℃ for up to 90 days after collection for CT/GC and up to 24 months for Trichomonas vaginalis.
    2. Swab (any source) – After collection, transport and store swab in transport tube at 2℃ to 30℃ until tested. Specimens must be assayed with the APTIMA Assay for CT/GC and/or TV within 60 days of collection. If longer storage is needed, freeze at -20℃ to -70℃ for up to 90 days after collection for CT/GC and up to 24 months for Trichomonas vaginalis.

    RESULTS

    Results are available within 72 hours 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.


  12. REJECTION

    Samples will be rejected if they are:

    • Unlabeled specimens or those with discrepancies between 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.

    Return to the Tests Performed page
    Return to the Delaware Public Health Laboratory page



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