1. Comparison of AmpFire and MY09/11 assays for HPV genotyping in anogenital specimen of Rwandan men who have sex with men
- Author
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Kanyabwisha, Faustin, Kim, Hae-Young, Shi, Qiuhu, Murenzi, Gad, Tuyisenge, Patrick, Kubwimana, Gallican, Munyaneza, Athanase, Murangwa, Anthère, Turizigiye, Onesphore, Da Costa, Maria, Nsengiyumva, Boniface, Chen, Xin, Mutesa, Leon, Anastos, Kathryn M, and Palefsky, Joel M
- Subjects
Sexually Transmitted Infections ,Infectious Diseases ,HIV/AIDS ,Clinical Research ,MSM ,MY09 ,11 ,AmpFire ,Anal hrHPV ,Penile hrHPV ,MY09/11 - Abstract
IntroductionThe AmpFire HPV genotyping Assay (Atila Biosystems, Mountain View, CA, USA) is a new test for which there are few data regarding its analytic performance and reliability. Using anal and penile swab specimens from a cohort study of men who have sex with men (MSM) in Rwanda, we compared high-risk HPV (hrHPV) detection by AmpFire done at two laboratories, one at University of California San Francisco (UCSF) and the other Rwanda Military Hospital, and well-validated MY09/11-based assay done at UCSF.MethodsAnal and penile specimens collected from 338 MSM from March 2016 to September 2016 were tested for high-risk HPV genotypes (hrHPV) by MY09/11, AmpFire UCSF and AmpFire RMH. Cohen's kappa coefficient was used to test for reproducibility.ResultsThe hrHPV positivity by MY09/11 and AmpFire UCSF was 13% and 20.7% (k = 0.73) for anal specimens and was 26.3% and 32.6% (k = 0.67) for penile specimens. Specifically, good reproducibility was for types 16 and 18 (k = 0.69 and k = 0.71) for anal specimens and (k = 0.50 and k = 0.72) for penile specimens. The hrHPV positivity by AmpFire at UCSF and RMH was 20.7% for both laboratories (k = 0.87) for anal specimens and was 34.9% and 31.9% (k = 0.89) for penile specimens. Specifically, excellent reproducibility was for types 16 and 18 for anal specimens (k = 0.80 and k = 1.00) and penile specimens (k = 0.85 and k = 0.91).ConclusionResults show that MY09/11 and AmpFire assays have good reproducibility while the AmpFire UCSF and RMH assays have excellent reproducibility. These results show that AmpFire is a promising HPV genotyping test.
- Published
- 2023