Chlamydia/ N.gonorrhoeae, Qualitative TMA and HSV 1/2 DNA, Real-Time PCR, Pap Vial

Test Code
91436

CPT Codes
87491, 87591, 87529 (x2)

Includes
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital
Herpes Simplex Virus, Type 1 and 2 DNA, Real-Time PCR, Pap Vial

Preferred Specimen
1 mL liquid cytology (PreservCyt®) Preservative (ThinPrep®) collected in an Aptima® transfer tube or
0.5 mL SurePath™ Preservative Fluid collected in an Aptima® transfer tube or
20 mL liquid cytology (PreservCyt®) Preservative (ThinPrep®)

Minimum Volume
1 mL liquid cytology in Aptima® transfer tube • 0.5 mL SurePath™ Preservative fluid • 20 mL liquid cytology • 10 mL SurePath™ fluid

Other Acceptable Specimens
10 mL SurePath™ Fluid

Instructions

PreservCyt® or SurePath™ material already processed for cytology or PAP are not acceptable.

Labs performing cytology: Aliquot PreservCyt®  solution before performance of liquid based cytology testing.

PreservCyt®: Transfer 1 mL PreservCyt® solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).

SurePath™: SurePath™ fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).

Note: Results from the Aptima® Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.

The Aptima® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.


For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng



Transport Temperature
Room temperature

Specimen Stability
PreservCyt® in Aptima® Transport Tube
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 30 days

SurePath™ Fluid in Aptima® Transport Tube
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable

PreservCyt® (ThinPrep®)
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable

SurePath™ Fluid
Room temperature: 4 days
Refrigerated: 4 days
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
PreservCyt® or SurePath™ material previously processed for cytology • PreservCyt® with excess mucus

Methodology
Real-Time Polymerase Chain Reaction • Transcription-Mediated Amplification (TMA)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up and Report available: See individual assays

Reference Range
C. trachomatis RNA, TMA Not detected
N. gonorrhoeae RNA, TMA Not detected
HSV-1 DNA Not detected
HSV-2 DNA Not detected


Clinical Significance
Diagnosis of the three most common sexually transmitted infections.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.