Candida albicans and Candida glabrata, NAA
Use
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
Special Instructions
The test was developed by Labcorp, which determined its performance characteristics. However, it has not received clearance or approval from the Food and Drug Administration, as the FDA considers such clearance or approval unnecessary for this type of testing. This test is specific for Candida albicans and Candida glabrata and is intended to assist in the diagnosis of vulvovaginal candidiasis in the suitable patient demographic.
Limitations
The test, while useful for detecting Candida albicans and Candida glabrata, has its limitations. It has not been cleared or approved by the FDA but is determined by Labcorp to meet performance standards. The test might not account for all strains of Candida or other possible causes of vaginitis, thereby limiting its diagnostic range. It is crucial for healthcare providers to integrate the test results with other clinical data for comprehensive diagnosis. Additionally, published data suggests that up to 65% of Candida glabrata cases may exhibit reduced susceptibility to fluconazole, which could affect treatment outcomes.
Methodology
PCR-based (NAA)
Biomarkers
LOINC Codes
- 11502-2
- 69562-7
- 69563-5
- 69562-7
- 69563-5
Result Turnaround Time
3-4 days
Related Documents
For more information, please review the documents below
Specimen
Vaginal 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 to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.
Storage Instructions
Maintain specimen at room temperature or refrigerate (2°C to 30°C).
Causes for Rejection
Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions, including specimens received frozen; specimens received after prolonged delay (usually >72 hours); specimen leaked in transit; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; Aptima® urine transport; Aptima® swab transport >30 days from collection; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non-Aptima® swab submitted in Aptima® transport device; transport device with multiple swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 30 days |
| Refrigerated | 30 days |
| Frozen | Not acceptable |