Casandra Test Code QD29880Version 1 (DRAFT)
HPV Genotypes 16,18/45, Post‑Hysterectomy, Vaginal
Use
This test identifies human papillomavirus (HPV) genotypes 16, 18, and 45 in post‑hysterectomy vaginal specimens using the Aptima HPV mRNA E6/E7 assay methodology. Detection of these high‑risk HPV genotypes contributes to assessing the risk for HPV‑related disease post‑hysterectomy and informing clinical management in women without a cervix. The inclusion of genotype 45 enhances detection of adenocarcinoma‑associated high‑risk HPV types. The mRNA‑based assay has demonstrated high specificity compared to DNA testing.
Special Instructions
Not provided.
Limitations
The test is validated only for post‑hysterectomy vaginal specimens—not intended for cervical or other specimen types. It includes only genotypes 16, 18, and 45; other high‑risk types are not detected. Clinical interpretation should consider that other high‑risk HPV infections may not be captured.
Methodology
Biomarkers
HPV‑16
MicroorganismOther
Other • Binary (Detected / Not Detected)
HPV‑18
MicroorganismOther
Other • Binary (Detected / Not Detected)
HPV‑45
MicroorganismOther
Other • Binary (Detected / Not Detected)
Result Turnaround Time
Related Documents
For more information, please review the documents below
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Volume
Container
Storage Instructions