Patient Preparation

If urine is to be collected, instruct patient not to urinate for at least 1 hour prior to specimen collection.

Patient Instructions - Aptima Vaginal Swab

Collect

Endocervix, female: Aptima Unisex Swab Specimen Collection Kit. Remove excess mucus from the cervix with the white-shafted cleaning swab and discard; the cleaning swab is not an acceptable specimen. Insert the blue-shafted specimen collection swab into the endocervical canal and rotate for 10-30 seconds. Withdraw the swab carefully to avoid contact with the vaginal mucosa and place in the transport tube immediately. Break shaft at score line and leave swab in the transport tube.

Vagina, female, clinician-collected or self-collected: Aptima Vaginal Swab Specimen Collection Kit. Insert pink-shafted swab into the vagina about 2 inches past the introitus and gently rotate for 10-30 seconds. Withdraw the swab without touching the skin and immediately place in the transport tube. Break shaft at score line and leave swab in the transport tube.

Urine, male and female: collect 20-30 mL of first catch urine into a sterile urine collection cup. Transfer approximately 2 mL of urine to the Aptima Urine Specimen Collection Kit transport tube. The correct volume of urine is between the black Fill Area lines on the transport tube label. Urine must be transferred to the transport tube within 24 hours of collection.

PreservCyt (ThinPrep) liquid cytology specimen: Follow collection instructions provided by Cytology. See Specimen Preparation instructions below for STD testing.

See specimen collection guidelines here and here.

Specimen Preparation

Endocervical and vaginal swabs: transfer to transport tube immediately after collection. Break shaft at score line and leave swab in the transport tube. If any transport liquid spills, open a new kit and recollect the specimen.

Urine: transfer approximately 2 mL of urine to the transport tube within 24 hours of collection. The correct volume of urine is between the black Fill Area lines on the transport tube label.

PreservCyt (ThinPrep) liquid cytology specimen: Uncap the Aptima Specimen Transfer Tube, placing the cap with the threads up on a clean surface. Vortex the PreservCyt vial for 3 to 10 seconds. Uncap the PreservCyt vial and place the cap on the bench with the threads facing up. Within 1 minute of vortexing, transfer 1 mL of the PreservCyt specimen into the Aptima Specimen Transfer Tube. Recap the transfer tube tightly and invert gently 2 to 3 times to ensure complete mixture of sample. Recap the PreservCyt vial and deliver to cytology for Pap testing.

Unacceptable Conditions

  • The large white-shafted swab is for preparatory cleaning of the endocervix and is not accepted.
     
  • Swab specimens must be collected and transported in the manufacturer's specific kits; specimens submitted on other types of swabs are not accepted.
     
  • Specimen in swab transport tube without a swab is not accepted.
     
  • Over- or under-filled urine transport tubes are not accepted. Urine volume must be between the black Fill Area lines.
     
  • Unpreserved urine >24 hours old is not accepted.
     
  • Swab transport tube with low level of fluid (tube spilled at time of collection) is not accepted.
     
  • Vaginal swab in Unisex transport tube or endocervical swab in Vaginal transport tube are not accepted.
     
  • Swab specimen with swab bent over in the transport tube instead of broken at the scored mark is not accepted.
     
  • PreservCyt specimen that has been entered by Cytology prior to delivery to the lab for aliquoting for STD testing is not accepted.
     
  • PreservCyt specimen submitted in the unisex, vaginal or urine transport tube is not accepted.
     
  • Leaking specimens are not accepted.
     
  • Male urethral swabs are not accepted

Storage/Transport Temperature

All specimen types: ambient (room temperature) or refrigerated.

Stability (from collection to initiation)

  • Endocervical and vaginal swabs in transport tube: ambient (room temperature) or refrigerated, 60 days; frozen, 12 months
     
  • Urine in Aptima tube: ambient (room temperature) or refrigerated, 30 days; frozen, 12 months
     
  • Urine, unpreserved (not a preferred specimen): ambient (room temperature) or refrigerated, 24 hours
     
  • PreservCyt specimen in Specimen Transfer Tube: ambient (room temperature), 14 days; refrigerated, 30 days; frozen, 12 months
     
  • PreservCyt specimen prior to transfer to Specimen Transfer Tube: refrigerated, 30 days

Performed

Mon, Wed, Fri

Remarks

Specimen source is required.

Endocervix, vaginal and PreservCyt specimens are tested at ALI. Male urethral swabs collected with the Unisex Collection Kit are sent to ARUP for testing (STD PANEL 1). Testing for T. vaginalis is not available on non-genital sources.

Performance of this assay has not been evaluated in pregnant women.

Department

Microbiology

Ordering Recommendations

This test is intended for medical purposes only and is not valid for evaluation of suspected sexual abuse or for other forensic purposes.

Performance of this assay has not been evaluated in pregnant women for Trichomonas vaginalis.

Culture is recommended for detection of cases of suspected sexual abuse or suspected failure of therapy. For culture, order GC Culture (performed at ALI, see specimen collection requirements in this directory) and Chlamydia trachomatis Culture (performed at ARUP, test number 0060850 - click here for specimen requirements).

Performed

Mon, Wed, Fri

Methodology

Qualitative assays on the Panther system:

  • Hologic Aptima Combo 2 Transcription-Mediated Amplification assay.
  • Hologic Aptima Trichomonas vaginalis Transcription-Medicated Amplification assay.

 

Reported

On the same day performed.

Interpretive Data

A negative result does not preclude a possible infection because results are dependent on adequate specimen collection. Test results may be affected by improper specimen collection or target levels below the assay limit of detection. Additional testing should be considered if results are inconsistent with the patient's clinical signs and symptoms or risk factors.

To resolve an indeterminate result, a new specimen should be submitted; this will result in an additional charge. Clinical judgment should be used to determine appropriate patient management. Contact the Microbiology laboratory if further information is needed.

Positive results for Chlamydia trachomatis and/or Neisseria gonorrhoeae are reported to the Maine CDC.

 

Performance of the Hologic Aptima TMA T. vaginalis assay has not been evaluated in pregnant women.

The Hologic Aptima TMA C. trachomatis and N. gonorrhoeae assay is not cleared or approved by the FDA for testing female urine specimens. The Hologic Aptima TMA T. vaginalis assay is not cleared or approved by the FDA for testing male and female urine specimens. These tests were developed and the performance characteristics were determined by ALI. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.

CPT Codes

87491 Chlamydia trachomatis, 87591 Neisseria gonorrhoeae, 87661 Trichomonas vaginalis

Collection

Patient Preparation

If urine is to be collected, instruct patient not to urinate for at least 1 hour prior to specimen collection.

Patient Instructions - Aptima Vaginal Swab

Collect

Endocervix, female: Aptima Unisex Swab Specimen Collection Kit. Remove excess mucus from the cervix with the white-shafted cleaning swab and discard; the cleaning swab is not an acceptable specimen. Insert the blue-shafted specimen collection swab into the endocervical canal and rotate for 10-30 seconds. Withdraw the swab carefully to avoid contact with the vaginal mucosa and place in the transport tube immediately. Break shaft at score line and leave swab in the transport tube.

Vagina, female, clinician-collected or self-collected: Aptima Vaginal Swab Specimen Collection Kit. Insert pink-shafted swab into the vagina about 2 inches past the introitus and gently rotate for 10-30 seconds. Withdraw the swab without touching the skin and immediately place in the transport tube. Break shaft at score line and leave swab in the transport tube.

Urine, male and female: collect 20-30 mL of first catch urine into a sterile urine collection cup. Transfer approximately 2 mL of urine to the Aptima Urine Specimen Collection Kit transport tube. The correct volume of urine is between the black Fill Area lines on the transport tube label. Urine must be transferred to the transport tube within 24 hours of collection.

PreservCyt (ThinPrep) liquid cytology specimen: Follow collection instructions provided by Cytology. See Specimen Preparation instructions below for STD testing.

See specimen collection guidelines here and here.

Specimen Preparation

Endocervical and vaginal swabs: transfer to transport tube immediately after collection. Break shaft at score line and leave swab in the transport tube. If any transport liquid spills, open a new kit and recollect the specimen.

Urine: transfer approximately 2 mL of urine to the transport tube within 24 hours of collection. The correct volume of urine is between the black Fill Area lines on the transport tube label.

PreservCyt (ThinPrep) liquid cytology specimen: Uncap the Aptima Specimen Transfer Tube, placing the cap with the threads up on a clean surface. Vortex the PreservCyt vial for 3 to 10 seconds. Uncap the PreservCyt vial and place the cap on the bench with the threads facing up. Within 1 minute of vortexing, transfer 1 mL of the PreservCyt specimen into the Aptima Specimen Transfer Tube. Recap the transfer tube tightly and invert gently 2 to 3 times to ensure complete mixture of sample. Recap the PreservCyt vial and deliver to cytology for Pap testing.

Unacceptable Conditions

  • The large white-shafted swab is for preparatory cleaning of the endocervix and is not accepted.
     
  • Swab specimens must be collected and transported in the manufacturer's specific kits; specimens submitted on other types of swabs are not accepted.
     
  • Specimen in swab transport tube without a swab is not accepted.
     
  • Over- or under-filled urine transport tubes are not accepted. Urine volume must be between the black Fill Area lines.
     
  • Unpreserved urine >24 hours old is not accepted.
     
  • Swab transport tube with low level of fluid (tube spilled at time of collection) is not accepted.
     
  • Vaginal swab in Unisex transport tube or endocervical swab in Vaginal transport tube are not accepted.
     
  • Swab specimen with swab bent over in the transport tube instead of broken at the scored mark is not accepted.
     
  • PreservCyt specimen that has been entered by Cytology prior to delivery to the lab for aliquoting for STD testing is not accepted.
     
  • PreservCyt specimen submitted in the unisex, vaginal or urine transport tube is not accepted.
     
  • Leaking specimens are not accepted.
     
  • Male urethral swabs are not accepted

Storage/Transport Temperature

All specimen types: ambient (room temperature) or refrigerated.

Stability (from collection to initiation)

  • Endocervical and vaginal swabs in transport tube: ambient (room temperature) or refrigerated, 60 days; frozen, 12 months
     
  • Urine in Aptima tube: ambient (room temperature) or refrigerated, 30 days; frozen, 12 months
     
  • Urine, unpreserved (not a preferred specimen): ambient (room temperature) or refrigerated, 24 hours
     
  • PreservCyt specimen in Specimen Transfer Tube: ambient (room temperature), 14 days; refrigerated, 30 days; frozen, 12 months
     
  • PreservCyt specimen prior to transfer to Specimen Transfer Tube: refrigerated, 30 days

Performed

Mon, Wed, Fri

Remarks

Specimen source is required.

Endocervix, vaginal and PreservCyt specimens are tested at ALI. Male urethral swabs collected with the Unisex Collection Kit are sent to ARUP for testing (STD PANEL 1). Testing for T. vaginalis is not available on non-genital sources.

Performance of this assay has not been evaluated in pregnant women.

Department

Microbiology

Ordering

Ordering Recommendations

This test is intended for medical purposes only and is not valid for evaluation of suspected sexual abuse or for other forensic purposes.

Performance of this assay has not been evaluated in pregnant women for Trichomonas vaginalis.

Culture is recommended for detection of cases of suspected sexual abuse or suspected failure of therapy. For culture, order GC Culture (performed at ALI, see specimen collection requirements in this directory) and Chlamydia trachomatis Culture (performed at ARUP, test number 0060850 - click here for specimen requirements).

Performed

Mon, Wed, Fri

Methodology

Qualitative assays on the Panther system:

  • Hologic Aptima Combo 2 Transcription-Mediated Amplification assay.
  • Hologic Aptima Trichomonas vaginalis Transcription-Medicated Amplification assay.

 

Reported

On the same day performed.

Result Interpretation

Interpretive Data

A negative result does not preclude a possible infection because results are dependent on adequate specimen collection. Test results may be affected by improper specimen collection or target levels below the assay limit of detection. Additional testing should be considered if results are inconsistent with the patient's clinical signs and symptoms or risk factors.

To resolve an indeterminate result, a new specimen should be submitted; this will result in an additional charge. Clinical judgment should be used to determine appropriate patient management. Contact the Microbiology laboratory if further information is needed.

Positive results for Chlamydia trachomatis and/or Neisseria gonorrhoeae are reported to the Maine CDC.

 

Performance of the Hologic Aptima TMA T. vaginalis assay has not been evaluated in pregnant women.

The Hologic Aptima TMA C. trachomatis and N. gonorrhoeae assay is not cleared or approved by the FDA for testing female urine specimens. The Hologic Aptima TMA T. vaginalis assay is not cleared or approved by the FDA for testing male and female urine specimens. These tests were developed and the performance characteristics were determined by ALI. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.

Administrative

CPT Codes

87491 Chlamydia trachomatis, 87591 Neisseria gonorrhoeae, 87661 Trichomonas vaginalis