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SureSwab®, Candidiasis, PCR
Test Code16494
CPT Codes
87481 (x4)
Includes
C. albicans, DNA; C. glabrata, DNA; C. tropicalis, DNA; C. parapsilosis, DNA
Preferred Specimen
Vaginal swab in 0.7 mL APTIMA® Vaginal Collection or Multi-Test Collection kit (orange label)
Minimum Volume
0.3 mL
Other Acceptable Specimens
Vaginal swab in 0.7 mL APTIMA® Unisex Swab Collection Kit (white label)
Instructions
Follow the instructions provided in the APTIMA® Vaginal Collection or Multi-Test Collection kit.
Remove the swab from the packaging and insert the swab into the vagina about two inches inside the opening. Gently rotate for 10 to 30 seconds, making sure that the swab touches the wall of the vagina so that moisture is absorbed by the swab. 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.
Remove the swab from the packaging and insert the swab into the vagina about two inches inside the opening. Gently rotate for 10 to 30 seconds, making sure that the swab touches the wall of the vagina so that moisture is absorbed by the swab. 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.
Transport Container
APTIMA® Vaginal Swab Specimen Collection Kit
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 30 days
Refrigerated: 14 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Specimens from leaking, uncapped or broken container • Non-APTIMA® Vaginal Collection or Multi-Test Collection kit or Unisex Swab Collection Kit
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
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: Mon-Sat; Report available: 1-2 days
Reference Range
| C. albicans, DNA | Not detected |
| C. glabrata, DNA | Not detected |
| C. tropicalis, DNA | Not detected |
| C. parapsilosis, DNA | Not detected |
Clinical Significance
Test is for the diagnosis of Candida vulvovaginitis.
