Human Papillomavirus (HPV) High Risk by in situ Hybridization, Paraffin

Casandra

Casandra Test Code AR12774Version 1 (DRAFT)

Performing Lab

Lab ARUP LaboratoriesLab Test ID 3002008CPT Code 88365

Human Papillomavirus (HPV) High Risk by in situ Hybridization, Paraffin

Also known as: HPVHR ISH

Clinical Use

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Use

This test is designed to detect high-risk subtypes of human papillomavirus (HPV) using in situ hybridization (ISH), which is valuable for assessing potential cancer risk. High-risk HPV subtypes are associated with the development of certain types of cancer, particularly cervical cancer and other anogenital or head and neck cancers. This test aids in the diagnosis and determination of the presence of high-risk HPV genotypes in formalin-fixed paraffin-embedded tissue samples.

Special Instructions

Not provided.

Limitations

This in situ hybridization technique is not cleared or approved by the FDA, and its performance characteristics are solely developed by ARUP Laboratories as a laboratory developed test. Limitations include potential signal variability due to tissue processing differences and fixation quality, which could affect result interpretation. Decalcified tissues and tissues fixed in non-standard fixatives are unacceptable as they may yield unreliable results. Frozen specimens are also unacceptable, and specimens should be protected from excessive heat during transport.

Test Details

New York Approved