Performance of AmpFire HPV assay on Neck Cervical Lymph Node Aspirate and Oropharyngeal Samples

Abstract Early determination of high-risk human papillomaviruses causing oropharyngeal squamous cell carcinomas (OPSCC) may influence treatment. The objectives were to evaluate the performance of a new rapid isothermal nucleic acid amplification point of care HPV test (AmpFire HPV) on fine needle neck aspirates (FNA) of cervical lymph nodes and oropharyngeal swabs and saliva (OPS) which had been previously tested by the cobas HPV assay. The comparison was performed on 56 FNA and 81 OPS. The two assays showed strong agreement (94.6%, K = 0.88) on FNA and fair agreement (65.4%, K = 0.34) on OPS. AmpFire HPV performed on FNA demonstrated a sensitivity of 76.7% and specificity of 81.8% for the prediction of p16 antigens in OPSCC with results available in 1.5 hours.