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

Minimum Volume

1 mL PreservCyt ThinPrep in Aptima transport tube • 0.5 mL SurePath in Aptima transport tube • 2 mL PreservCyt ThinPrep vial • 1 mL SurePath vial

Other Acceptable Specimens

2 mL PreservCyt ThinPrep vial • 1 mL SurePath vial

Instructions

Aptima transport tubes accepted: Aptima Multitest 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 ThinPrep: 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

Aptima transport tube
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 14 days

ThinPrep 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 • PreserveCyt 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

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.