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 PreservCyt® ThinPrep® collected in an Aptima® transport tube or
0.5 mL SurePath™ Fluid collected in an Aptima® transport tube


Other Acceptable Specimens
2 mL PreservCyt® ThinPrep® vial • 1 mL SurePath™ vial


Instructions
Aptima® Transport tubes accepted:
Aptima® Multi-test Collection Tube (orange label), Aptima® Unisex Swab Specimen Collection Kit Tube (white label), Aptima® Specimen Transfer Tube (green label).

Labs performing cytology: Aliquot PreservCyt® ThinPrep® or SurePath™ solution within 4 days of collection and before performance of liquid based cytology testing.

PreservCyt® Thin Prep®: Sample any visible lesions. Transfer 1 mL of PreservCyt® solution into Aptima® transfer tube. Ship to lab

Surepath™: Sample any visible lesions. Transfer 0.5 mL of SurePath™ preservative fluid into Aptima® transfer tube. Ship to lab.


Transport Temperature
Room temperature


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

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

PreservCyt® ThinPrep® Vial
Room temperature: 4 days
Refrigerated: 4 days
Frozen: Unacceptable

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


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
PreservCyt® ThinPrep® or SurePath™ material previously processed for cytology • PreservCyt® ThinPrep® or SurePath™ with excess mucus • Specimens submitted in Aptima® tubes with pierced foil lids


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: Daily; Report available: Next day


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.