SureSwab® Herpes Simplex Virus, Type 1 and 2 mRNA, TMA
Test Summary
The SureSwab®, HSV Type 1/2 mRNA, TMA assay is intended for use as an aid in the diagnosis of HSV-1 and/or HSV-2 infections in symptomatic male and female patients. The assay is not validated for cerebral spinal fluid samples or for use in prenatal screening.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
1 male or female anogenital lesion swab collected in APTIMA® Vaginal Collection Kit or Multi-Test Collection Kit (orange label)
Minimum Volume
N/A
Instructions
Follow the instructions provided in the APTIMA® Vaginal Collection Kit or Multi-Test Collection Kit (orange label). Remove the swab from the packaging and swab any visible lesions. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube so that the tip of the swab is visible below the tube label. Carefully break the swab shaft at the score line against the side of the tube and discard the top portion of the swab shaft. Tightly screw the cap onto the tube.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 36 days
- Refrigerated: 36 days
- Frozen: 36 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Non APTIMA® Collection Kit • Aptima® Unisex Collection Kit (white label) • Leaking samples • Uncapped samples • Broken container
Order Code
HSVSS
EPIC (Premier) Code
LAB5929
Includes
N/A
CPT Code
- 87529 X2
Billing Code
- 670068
CPT Statement
Methodology
Transcription Mediated Amplification (TMA)
FDA Status
FDA Approved
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Testing
Reference Range
| HSV 1 | Not detected |
| HSV 2 | Not detected |
Setup Schedule / Expected Turnaround Time
Daily; Report available: 2 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
1 male or female anogenital lesion swab collected in APTIMA® Vaginal Collection Kit or Multi-Test Collection Kit (orange label)
Minimum Volume
N/A
Instructions
Follow the instructions provided in the APTIMA® Vaginal Collection Kit or Multi-Test Collection Kit (orange label). Remove the swab from the packaging and swab any visible lesions. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube so that the tip of the swab is visible below the tube label. Carefully break the swab shaft at the score line against the side of the tube and discard the top portion of the swab shaft. Tightly screw the cap onto the tube.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 36 days
- Refrigerated: 36 days
- Frozen: 36 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Non APTIMA® Collection Kit • Aptima® Unisex Collection Kit (white label) • Leaking samples • Uncapped samples • Broken container
Result Information
Methodology
Transcription Mediated Amplification (TMA)
Testing Laboratory
N/A
Reference Range
| HSV 1 | Not detected |
| HSV 2 | Not detected |
Setup Schedule / Expected Turnaround Time
Daily; Report available: 2 days