Tulsa Medical Laboratories is pleased to announce the addition of three new tests to our molecular testing menu; the Aptima Bacterial Vaginosis Assay, the Aptima Mycoplasma Genitalium Assay and the Aptima CV/TV (Candida Vaginitis/Trichomonas Vaginalis).
- The Aptima BV assay is an FDA approved in vitro qualitative NAAT that utilizes real time TMA for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis, including Lactobacillus (L.gasseri, L.crispatus, and L. jensenii), Gardnerella vaginalis and Atopobium vaginae.
The assay gives a qualitative result for BV and does not report for individual organisms.
- The Aptima Mycoplasma genitalium assay is an FDA approved in vitro qualitative NAAT for the detection of rRNA from Mycoplasma genitalium. The assay is intented as an aid in the diagnosis of M. genitalium urogenital infections in male and female patients suspected of M. genitalium infection.
- The CV/TV assay is an FDA approved, qualitative in vitro NAAT for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. The assay uses real time TMA to detect and report results for the following organisms;
- Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dublinensis)
- Candida glabrata
- Trichomonas vaginalis
These assays are not available from the thin prep pap test vial and must be collected in the Aptima Multi test swab (orange Aptima tube). These assays will replace the current BD affirm vaginitis panel which will not be available after March 13, 2020. The assays may be ordered individually or as a “full vaginal panel” which would be CT/NG, BV, CV/TV and M. genitalium. We are excited to be able to offer a one-swab solution for vaginitis testing.
If you are interested in ordering supplies for these tests or have questions about the tests please feel free to contact the molecular department supervisor, Julie Gregg at (918) 281-6865.
Interested? Call: (918) 281-6865
2018 has been a busy year for the molecular department. Two new assays have been added to our molecular test menu; APTIMA HSV 1 & 2 and the BD AFFIRM VAGINITIS PANEL.
The Aptima HSV 1 & 2 assay is a fully automated, real time nucleic acid amplification test that will qualitatively detect and differentiate between HSV-1 and HSV-2. The assay is only for active anogenital skin lesions collected in the Aptima Multi test swab. The assay yields results in 2.7 hours after the start of testing as opposed to several days with traditional culture methods.
The BD Affirm Vaginitis Panel is available from a swab that tests for the presence of DNA from Trichomonas, Gardnerella bacteria and seven types of Candida. It does not differentiate the types of Candida but is a rapid test for the most common causes of vaginitis.
Tulsa Medical lab has also been validated for testing chlamydia and gonorrhea mRNA from urine samples utilizing the Aptima Combo 2 assay on the Hologic Panther system.
In addition to HPV testing with high risk genotyping for pap smears, the Aptima high risk HPV and the Aptima Genotyping assays are also available for anal pap samples.
In August of 2016, the Tulsa Medical Lab Molecular Department completed validation studies to apply the Hologic Aptima HPV Genotyping Assay to head and neck fine needle aspiration samples.
Head and neck cancer is the 6th most common cancer worldwide with over 550,000 new cases each year. 90% of head and neck cancers are squamous cell carcinoma.
Currently, 72% of the oropharyngeal squamous cell carcinomas in the United States are HPV-related. HPV 16 is responsible for 90 to 95% of those cancers. Experts agree that E6/E7 detection of mRNA transcripts is generally regarded as the gold standard for HPV detection.
The Aptima HPV Genotyping Assay targets the E6/E7 mRNA of HPV 16 and 18/45 which makes it a superlative choice for determining the presence of HPV 16 in fine needle aspiration samples.
The 5 year survival rate for patients with HPV positive squamous cell carcinoma is greater than 80% compared to 40% for patients with HPV negative head and meck squamous cell carcinoma.
For more information on this exciting and affordable test, please contact the molecular department at 918-281-6865.
The Cellient™ Automated Cell Block System is the first fully-automated cell blocking system built on ThinPrep® technology. It improves capture by maximizing cellularity even from small/scanty samples. It also improves presentation by maintaining crisp, clear cellular architectural detail with concentrations of cells within the block.
This system allows for review of cytology and cell block simultaneously. It improves consistency by being fully automated with minimal operator dependency, resulting in less cross-contamination risk along with consistently rapid processing time (45 minutes or less).