TEST:

AmpFire HPV Assay

"The excellent intra- and interlaboratory reproducibility and the established clinical performance, together with the platforms' simplicity, make these assays particularly applicable to low-resource settings."

Ct value represented a good triage marker in both PCR-based and isothermal amplification HPV detection.

"Forty-seven patients with cervical cancer were enrolled on this study between 2017 and 2022, either as part of a standard-of-care (SOC) treatment banking protocol (33 patients) or as part of a clinical trial combining a therapeutic HPV vaccine (PDS0101; Immunocerv, 14 patients)...Treatment with a therapeutic HPV vaccine was associated with a more rapid decline in cfHPV DNA. Further analysis of cfDNA kinetics could provide valuable information on the relationship between cfDNA levels, treatment response, and clinical outcomes."

The AmpFire HPV assay demonstrated excellent analytic performance in both detection of HPV and clinically significant cervical disease. AmpFire HPV is a promising option to increase access to affordable, type-specific HPV screening for cervical cancer in LMICs.

"Agreement between the two assays was good, especially for HPV16/18. Atila’s protocol takes less time to obtain results, is more economical and uses fewer specialized equipment to run."

"It’s accuracy with self-collection makes it applicable for mass screening programs. The full data will be reported."

"The agreement observed between positives and negatives for HPV-DNA and p16 INK4A was 93.8% and a ki of 0.848. Conclusions The AmpFire HPV Tests are simple sample-to-answer and low cost assays for detection and genotyping of HPV in HN FFPE samples."

"Conclusions In summary, the Atila AmpFire HPV assay demonstrated excellent analytic sensitivity and specificity for detection and genotyping of 15 HR HPV genotypes. Assay parameters of simple specimen processing, small sample size requirement, rapid turnaround time and being near instrument-free render it well suited for HPV detection and genotyping in FFPE specimens."

"However, if the above trend continues the dry brush transport could markedly simplify and reduce costs for specimen transport. Used with self-collected vaginal samples, it may become an important addition to population based cervical cancer screening programs."

"The test is simple to perform with minimal training. Sample to result is about an hour that is fast enough to enable treatment of the patient during the visit."

"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."

No abstract available

No abstract available