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

Test Code
91437


CPT Codes
87491, 87591, 87529 (x2), 87661

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


Preferred Specimen

1 mL liquid cytology (PreservCyt®) preservative (ThinPrep®) collected in an APTIMA® transfer tube (green label), or

0.5 mL SurePath™ preservative fluid collected in an APTIMA® transfer tube (green label)



Minimum Volume
1 mL PreservCyt (ThinPrep) • 0.5 mL SurePath fluid in APTIMA


Other Acceptable Specimens
2 mL (2 mL minimum) PreservCyt® ThinPrep® vial, or
1 mL (1 mL minimum) SurePath™ vial


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 transfer tube (green label).

SurePath: SurePath fluid must be transferred to APTIMA tube within 4 days of collection. Transfer 0.5 mL SurePath solution into APTIMA transfer tube(green label).



Transport Temperature
Room temperature


Specimen Stability
PreservCyt ThinPrep and SurePath in APTIMA transport tube
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 14 days

PreservCyt ThinPrep Vial and 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 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
T. vaginalis RNA, QL TMA Not detected


Clinical Significance
Diagnosis of the four 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.