Vaginitis (VG), Herpes Simplex Virus (HSV), NuSwab®
Use
This test is intended to be used as an aid to the diagnosis of bacterial vaginosis (BV) in women with a clinical presentation consistent with this disorder. The BV test utilizes semiquantitative PCR analysis of the three most predictive marker organisms (Atopobium vaginae, BVAB-2, and Megasphaera-1) to generate a total score that correlates directly with the presence or absence of BV. In this test system, samples with a total score of 0 to 1 are considered negative for BV, samples with a score of 3 to 6 positive for BV, and samples with a score of 2 indeterminate for BV. Detect the presence of Candida albicans and Candida glabrata DNA in vaginal samples as an aid to the diagnosis of vulvovaginal candidiasis in symptomatic women. Diagnosis of Trichomonas vaginalis infections. Detect and type active HSV shedding.
Special Instructions
Ensure proper collection using the Aptima® swab. Rotate the swab on the vaginal wall for 10-30 seconds to absorb fluid, then place it into the transport tube and secure the cap tightly. Do not freeze the swab.
Limitations
The test was developed and validated by Labcorp without FDA clearance or approval, which is deemed unnecessary by FDA. Negative HSV NAA results suggest no active shedding but cannot confirm the absence of prior infection.
Methodology
PCR-based (qPCR)
Biomarkers
LOINC Codes
- 69565-0
- 69566-8
- 69567-6
- 11502-2
- 69562-7
- 69563-5
- 62461-9
- 16130-7
- 16131-5
Result Turnaround Time
3-4 days
Related Documents
For more information, please review the documents below
Specimen
Cervical Swab
Volume
One swab
Minimum Volume
One swab
Container
Aptima® Multitest Swab Specimen Collection Kit or Aptima® Unisex Swab Specimen Collection Kit
Collection Instructions
Collect vaginal fluid sample using the Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds. Place the swab into the transport tube, break the swab shaft, and secure the tube cap tightly.
Storage Instructions
Maintain specimen at room temperature or refrigerate (2°C to 30°C).
Causes for Rejection
Specimens with incorrect patient identification, inappropriate transport conditions, or prolonged delays; specimens that are frozen, leaked, in expired or incorrect transport devices, or bloody.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 30 days |
| Refrigerated | 30 days |
| Frozen | Not acceptable |