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

Test Code
91436

CPT Codes
87491, 87591, 87529 (x2)

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

Preferred Specimen
Minimum 0.5 mL SurePath® preservative fluid collected in APTIMA® Vaginal Collection Kit (orange label)

Other Acceptable Specimens

Minimum 0.5 mL SurePath® preservative fluid submitted in: APTIMA® Transfer Tube (green label), or APTIMA® Unisex Swab Collection Kit • 1 mL PreservCyt® solution submitted in: APTIMA® Specimen Transfer Tube (green label), or APTIMA® Vaginal Collection Kit (orange label), or APTIMA® Swab Specimen Collection Kit

Instructions
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.

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

SurePath®: SurePath® fluid must be transferred to APTIMA® Specimen Transport Media within 4 days of collection. Transfer 0.5 mL of SurePath® preservative fluid into APTIMA® Vaginal Collection or Multi-Test Collection Kit (orange label) or APTIMA® Specimen Transfer tube (green label). Ship to lab.

PreservCyt®: Transfer 1 mL of PreservCyt® solution into APTIMA® Vaginal Collection or Multi-Test Collection Kit (orange label) or APTIMA® Specimen Transfer tube (green label). Ship to lab.

Transport Temperature
Room temperature

Specimen Stability
SurePath®
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Not established

PreservCyt®
Room temperature: 14 days
Refrigerated: 30 days
Frozen: Not established

Methodology
Real-Time Polymerase Chain Reaction (RT-PCR) • 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: Mon-Sat a.m.; Report available: 3 days

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.