Human Papillomavirus (HPV) High Risk Screen by Transcription-Mediated Amplification (TMA), with Reflex to Genotypes 16 and 18/45, ThinPrep

Casandra

Casandra Test Code AR29604Version 1 (DRAFT)

Performing Lab

Lab ARUP LaboratoriesLab Test ID 3016945CPT Codes 87624, 87625

Human Papillomavirus (HPV) High Risk Screen by Transcription-Mediated Amplification (TMA), with Reflex to Genotypes 16 and 18/45, ThinPrep

Also known as: HPV REFLEX

Clinical Use

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Use

This test is FDA-approved for routine cervical cancer screening in combination with cervical cytology (pap smear) in individuals 30 years or older with a cervix. It serves as a follow-up test for abnormal cytology results in individuals 21 years or older with a cervix. The genotyping assesses the presence or absence of high-risk HPV genotypes 16, 18, and/or 45, but only as a follow-up to an Aptima HPV assay positive result. The test detects E6/E7 viral messenger RNA of 14 high-risk HPV types associated with cervical cancer and its precursor lesions. It should not be used for screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under age 21.

Special Instructions

Not provided.

Limitations

This test does not discriminate between the 14 high-risk HPV types. Sensitivity may be affected by specimen collection methods, stage of infection, and the presence of interfering substances. A negative high-risk HPV result does not exclude the presence of other high-risk HPV types. This test should not be used as a stand-alone for screening or management of ASCUS in women under age 21.

Test Details

FDA Approved