TEST:

AmpFire HPV Assay

Our study underscores the urgent need for comprehensive and targeted interventions to reduce the burden of hr-HPV and the potential for cervical precancer/cancer among FCSWs in Ghana. We further highlight the importance of promoting continuous condom use among FCSWs during interactions with patrons and considering HIV status in the development and implementation of cervical precancer screening programs for FCSWs.

Three hundred and nine consenting WLWHIV on highly active antiretroviral therapy (HAART) aged 25-49 years had CCS with both VIA and HPV DNA tests. Participants' mean age was 42.6 ± 6.4 years, and the mean parity was 3.8±1.6. Thirty-six (11.7%) were VIA-positive while 90 (29.1%) were HPV-positive.

The mother-child approach is an excellent method to maximize primary and secondary prevention against cervical cancer.

"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."

"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."

"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."

"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."