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Chlamydia/Neisseria gonorrhoeae, Qualitative, TMA and HSV 1/2 DNA, Real-Time PCR, Pap Vial
Test Code91436
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