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Test Code LAB3523 APTIMA Gonococcus NAAT

Important Note

This test cannot be added to a previous Pap test order.

Please review complete specimen collection for each specimen type, making note of the important notes within the specimen requirements.

This testing is not approved for patients under the age of 14, please order a Reference Miscellaneous test on these patients so the specimen can be forwarded to a reference laboratory to perform the testing.

Test Name Alias

APTIMA Gonococcus NAAT| APTIMA GONOCOCCUS NAAT| ThinPrep | GC | gonorrhoeae | 7045

Clinical Information

N. gonorrhoeae is the causative agent of gonococcal (GC) infections, the majority of which are uncomplicated lower genital tract infections and may be asymptomatic.  However, if left untreated in women, infections can ascend and cause PID which can manifest as endometriosis, salpingitis, pelvic peritonitis, and tubo-ovarian abscesses.  A smaller percentage of persons with gonococcal infections may develop disseminated Gonococcal Infection.

 

Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution, APTIMA vaginal swabs, APTIMA endocervical unisex swabs, and male and female urine specimens from symptomatic and asymptomatic individuals are approved for testing.  Other specimen types are not acceptable.

 

Improper collection of the specimen may results in invalid results.  If the lab receives a swab specimen transport tube with no swabs, two swabs, a cleaning swab, or a swab not supplied by Hologic the specimen must be rejected.

 

A negative test result does not preclude the presence of a GC infection because results are dependent on adequate specimen collection, absence on inhibitors, and sufficient rRNA to be detected.

 

If a specimen has small numbers of GC cellular material, uneven distribution may occur which may affect the ability to detect small numbers of organisms in the collected material.  If negative results from the specimen do not fit with the clinical impression, a new specimen may be necessary.

 

Results for GC will be reported as Positive, Negative (presumed negative for GC rRNA) or Equivocal.  For specimens giving an Equivocal (indeterminate) result, a new specimen should be collected.

Specimen Requirements

Submit  only ONE of the following specimens:

 

Specimen Type: Cervical cytology specimen

Container/Tube: ThinPrep Vial

Collection Instructions:

Brush collection:

  1. Obtain an adequate sampling from the ectocervix using a plastic spatula. If desired, use lukewarm water to warm and lubricate the speculum. Water-soluble gel lubricant sparingly applied to the posterior blade of the speculum can be used if necessary. Select contoured end of plastic spatula and rotate it 360 degrees around the entire exocervix while maintaining tight contact with exocervical surface.
  2. Rinse the spatula as quickly as possible into the PreservCyt solution in the ThinPrep vial by swirling the spatula vigorously in the vial 10 times. Discard the spatula.
  3. Obtain as adequate sampling from the endocervix using an endocervical brush device. Insert the brush into the cervix until only the bottom-most fibers are exposed. Slowly rotate 1/4 or 1/2 turn in one direction. Do not over-rotate.
  4. Rinse the brush as quickly as possible into the PreservCyt solution in the ThinPrep vial by rotating the device in the solution 10 times while pushing against the PreservCyt vial wall. Swirl the brush vigorously to further release material. Discard the brush
  5. Tighten the cap so that the torque line on the cap passes the torque line on the vial
  6. Record the patient’s name and date of birth on the vial.

Broom collection:

  1. Obtain an adequate sampling from the cervix by inserting the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix.  Push gently, and rotate the broom in a clockwise direction five times.
  2. Rinse the broom in the PreservCyt solution in the ThinPrep vial by pushing the broom into the bottom of the vial 10 times, forcing the bristles apart.
  3. As a final step, swirl the broom vigorously to further release the material.
  4. Discard the collection device.
  5. Tighten the cap on the ThinPrep vial so that the torque line on the cap passes the torque line on the vial.
  6. Record the patient’s name and date of birth on the vial.

 

Specimen Type: Vaginal specimens

Container/Tube: APTIMA Vaginal Swab

Collection Instructions:

  1. Partially peel open the swab package.  Do not touch the soft tip or lay the swab down.
  2. Hold the swab so that the thumb and forefinger are positioned in the middle of the shaft covering the score line.  Do not hold the swab shaft below the score line.
  3. Carefully insert the swab into the vagina about 2 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.
  4. While holding the swab in the same hand, unscrew the cap from the tube.  Do not spill the contents of the tube.  Do not touch the top of the cap.
  5. Immediately place the swab in the transport tube so that the score line is at the top of the tube.
  6. Carefully break the swab shaft at the score line against the side of the tube.
  7. Discard the top portion of the swab shaft.
  8. Tightly screw the cap onto the tube, being careful not to touch the top of the cap.
  9. Record the patient’s name and date of birth on the vial.

Important Note: Collect the specimen using only the APTIMA Vaginal Swab Collection Kit when requesting APTIMA Gonococcus NAAT testing.  Other swabs are not acceptable for use with this assay.

 

Specimen Type: Endocervical specimens

Container/Tube: APTIMA Unisex Swab for Endocervical Specimens

Collection Instructions:

  1. Peel open the swab package.  Do not touch the soft tips or lay the swabs down.
  2. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab with the white shaft.  Discard this swab.
  3. Carefully insert the specimen collection swab (with the blue shaft) into the endocervical canal.  Gently rotate the swab for 10 to 30 seconds in the endocervical canal to ensure adequate sampling.
  4. Withdraw the swab carefully; avoid any contact with the vaginal mucosa.
  5. While holding the swab in the same hand, unscrew the cap from the tube.  Do not spill the contents of the tube.  Do not touch the top of the cap.
  6. Immediately place the swab in the transport tube so that the score line is at the top of the tube.
  7. Carefully break the swab shaft at the score line against the side of the tube.
  8. Discard the top portion of the swab shaft.
  9. Tightly screw the cap onto the tube, being careful not to touch the top of the cap.
  10. Record the patient’s name and date of birth on the vial.

Important Note: Collect the specimen using only the APTIMA Unisex Swab Collection Kit for Endocervical Specimens when requesting APTIMA Gonococcus NAAT testing.  Other swabs are not acceptable for use with this assay. APTIMA Unisex Swab for Endocervical Specimens is not available through Spectrum Health Laboratory Supplies. If a male swab is desired, please order the GC/CT PCR genital test and use the Abbot multi-collect specimen kit. If male APTIMA is desired, please use Urine specimen type.

 

 

Specimen Type: Urine

Container/Tube: Sterile urine cup

Volume: 20 to 30 mL

Collection Instructions:

  1. The patient should not have urinated for at least 1 hour prior to specimen collection.
  2. The patient should be directed to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a sterile urine cup free of any preservatives.  Female patients should not clean the labial area prior to providing the specimen.
  3. Record the patient’s name and date of birth on the cup.

 

Specimen Type: Urine

Container/Tube: APTIMA Urine Transport Tube

Volume: 20 to 30 mL collected in a sterile urine collection cup

Collection Instructions:

  1. The patient should not have urinated for at least 1 hour prior to specimen collection.
  2. The patient should be directed to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a sterile urine cup free of any preservatives.  Female patients should not clean the labial area prior to providing the specimen.
  3. Remove the cap of the APTIMA urine specimen transport tube.
  4. Transfer 2 mL of urine from the collection cup to 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 specimen transport tube label.
  5. Re-cap the urine specimen transport tube tightly.
  6. Record the patient’s name and date of birth on the vial.

Important Note: Urine specimens should be submitted using only a sterile urine cup or the APTIMA Urine Transport Tube when requesting APTIMA Gonococcus NAAT testing.  Other urine collection tubes are not acceptable for use with this assay.

Specimen Transport Temperature

ThinPrep vial: After collection, the PreservCyt Solution in the ThinPrep liquid Pap vial is transported and stored at room temperature or refrigerated until tested.

 

Swab Specimens: After collection, the vaginal or endocervical swab is transported and stored at room temperature or refrigerated until tested.

 

Urine specimens: Urine specimens still in the sterile urine cup must be transported to the laboratory stored at room temperature or refrigerated within 24 hours of collection.  Urine specimens transferred to the APTIMA Urine Transport Tube is transported and stored at room temperature or refrigerated until tested.

Special Instructions

See any Important Notes with specimen type above.

Best practice to avoid specimen contamination: Do not touch top of cap, make sure all caps are secured, individually bag specimens, change gloves if contaminated.

Rejection Criteria

  • Improper collection of the specimen may results in invalid results.  If the lab receives a swab specimen transport tube with no swabs, two swabs, a cleaning swab, or a swab not supplied by Hologic the specimen must be rejected.
  • If specimens are bagged together and a specimen leaks, all specimens in the bag will be canceled and a request for recollection will be made.
  • Invalid specimen types
  • Improper labeling of specimen - Spectrum Health Laboratory requires 2 patient identifiers (Name and Date of Birth or SH MRN)

Specimen Stability

ThinPrep vial: Specimens submitted in the ThinPrep liquid Pap vial must be transferred to an APTIMA Specimen Transfer Tube within 30 days of collection.  Once an aliquot of the PreservCyt Solution in the ThinPrep vial has been transferred to the APTIMA Specimen Transfer Tube, the specimen is stable for 30 days from the date of transfer if stored at room temperature or refrigerated.

 

Swab Specimens: The vaginal or endocervical swab must be tested within 60 days of collection.

 

Urine specimens: Urine specimens still in the sterile urine cup must be transferred to an APTIMA Urine Transport Tube within 24 hours of collection.  Urine specimens transferred to the APTIMA Urine Transport Tube are stable for 30 days from the date of transfer when stored at room temperature or refrigerated.

Test Frequency

Available Monday through Friday; usual TAT 1 to 2 days

Reference Range

Negative

Performing Department

MOLECULAR DIAGNOSTICS

Performing Department Laboratory Location

Spectrum Health Advanced Technology Laboratory (ATL), Grand Rapids, MI

Methodology

The APTIMA Nucleic Acid Amplification Test (NAAT) utilizes target capture, Transcription-Mediated Amplification (TMA) and Dual Kinetic Assay (DKA) technologies for the detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC). 

CPT

87591 - LAB GONOCOCCUS PCR RNA APTIMA

CDM Code

3900404

Epic Test ID

1230100361

Interface Order Alias

11776

Interface Information

Build information

Order Code: 11776

Result Code (DTA):

24016 - Gonococcus NAAT Aptima

24013 - Specimen Type Aptima

Questions (AOE):

Specimen type - Multiple Choice Question. Please choose from the following:

Cervical | Endocervical | Vaginal | Urine (First Voided)

Specimen source - Multiple Choice Question. Please choose from the following

Cervix | Endocervical | Vaginal | Urine (First Voided)

Mayo Access Code

SHO11776

LOINC

Not available

Reviewed Date

7/11/2016