Detection of high-risk human papillomavirus (HPV) by the novel AmpFire isothermal HPV assay among pregnant women in Pemba Island, Tanzania

Juliana, Naomi C. A.; Juma, Mohamed Hamad; Heijmans, Roel; Ouburg, Sander; Ali, Said M.; Chauhan, A. S.; Pemba, A. B.; Sazawal, Sunil; Morré, Servaas A.; Deb, Saikat; Ambrosino, Elena

doi:10.11604/pamj.2020.37.183.23367

Cited by 14 publications

(14 citation statements)

References 23 publications

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“…5 In addition, when compared to other tests, including the Roche cobas ® and Linear Array, an excellent concordance between these tests and AmpFire has been demonstrated for the detection of 15 hrHPV. 16 Further, Xpert has been widely used for the detection of various types of HPV, including hrHPV types. In Zimbabwe, an overall good concordance (77.2%, kappa = 0.698) between Xpert and Seegene Anyplex II HPV HR detection kit was found when testing hrHPV among women aged from 30 to 60 years.…”

Section: Discussionmentioning

confidence: 99%

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Agreement between Xpert and AmpFire tests for high-risk human papillomavirus among HIV-positive women in Rwanda

Murangwa

Desai

Gage

et al. 2022

African Journal of Laboratory Medicine

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Background: High-risk human papillomavirus (hrHPV) may cause more than 99% of cervical cancers worldwide. Little is known about performance differences in tests for hrHPV.Objective: This study analysed agreement for detection of hrHPV between the established, clinically validated Xpert HPV assay and the novel isothermal amplification-based AmpFire HPV genotyping assay.Methods: This study was nested in a larger project on cervical cancer screening among approximately 5000 women living with HIV in Kigali, Rwanda. This sub-study included 298 participants who underwent initial screening for cervical cancer using the Xpert HPV assay and visual inspection with acetic acid in 2017 and tested positive by either or both. Participants were rescreened using colposcopy, and cervical samples were collected between June 2018 and June 2019. Samples were then tested for HPV using the Xpert HPV assay and AmpFire HPV genotyping assay. Agreement between results from both tests was analysed using an exact version of McNemar test and chi-square test.Results: Overall agreement and kappa value for detection of hrHPV by Xpert and AmpFire were 89% and 0.77 (95% confidence interval: 0.70–0.85). AmpFire was marginally more likely to diagnose hrHPV-positive than Xpert (p = 0.05), due primarily to the extra positivity for HPV16 (p 0.001).Conclusion: Overall, there was good to excellent agreement between the Xpert and AmpFire when testing hrHPV types among women living with HIV. AmpFire was more likely to test extra cases of HPV16, the most carcinogenic HPV type, but the clinical meaning of detecting additional HPV16 infections remains unknown.

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Section: Discussionmentioning

confidence: 99%

“…The cut-off point values of positivity applied when using Xpert and AmpFire assays were defined according to the manufacturers’ instructions. 15 , 16 …”

Section: Methodsmentioning

confidence: 99%

Agreement between Xpert and AmpFire tests for high-risk human papillomavirus among HIV-positive women in Rwanda

Murangwa

Desai

Gage

et al. 2022

African Journal of Laboratory Medicine

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“…As eNat ® is not flammable, is able to inactivate infectious agents present in the sample and stabilizes nucleic acids in samples stored at room temperature 6,17 . Moreover, it is already routinely used as a medium for molecular HPV detection 8,18 and it could represents a valid alternative to ThinPrep ® PreservCyt ® . In addition, this study demonstrated an almost perfect agreement between vaginal swabs suspended in ThinPrep ® PreservCyt ® and eNat ® using the three different diagnostic assays.…”

Section: Discussionmentioning

confidence: 99%

“…To overcome these problems, a non-alcohol-based medium to suspend self-collected vaginal samples that supports HPV nucleic acid stability and that is suitable for molecular HPV analysis is necessary 5 . eNat ® (Copan Italia SpA, Brescia Italy) is a lysing based molecular collection medium already used for nucleic acids amplification assays [6][7][8] . Moreover, it preserves and stabilizes nucleic acids and desaturates proteins and inactivates microbial agents potentially contained in clinical samples.…”

Section: Introductionmentioning

confidence: 99%

Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep®PreservCyt® for vaginal swabs

Giubbi¹,

Martinelli²,

Vallini³

et al. 2022

Open Res Europe

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Human Papillomavirus (HPV) testing on self-collected samples allows for improved coverage rates of cervical cancer (CC) screening programs. ThinPrep®PreservCyt® (HOLOGIC®, USA) medium is widely used for the suspension of cervical and vaginal self-samples. However, this medium is costly, toxic, and flammable, involving special handling procedures which make its use difficult in screening programs, particularly in low- and middle-income countries. This pilot study aimed to evaluate the analytical performance of eNat® (Copan SpA), an alternative non-alcohol-based suspension medium, compared to ThinPrep®PreservCyt® (HOLOGIC®) for high-risk HPV (hrHPV) detection in vaginal self-collected swabs using three different real-time polymerase chain reaction (RT-PCR) HPV assays: Anyplex™II HPV28 (Seegene, Korea), Papilloplex® High Risk HPV (GeneFirst, UK), and HPV OncoPredict (Hiantis, Italy). 30 women, referred to colposcopy, were enrolled in this observational, prospective pilot study and asked to collect two vaginal self-taken samples, which were suspended in 5 mL of ThinPrep®PreservCyt® or eNat®. Nucleic acids were extracted from 200 μL using Microlab Nimbus platform (Seegene, Korea) and tested with the three different RT-PCR full-genotyping high-risk HPV assays. The HPV results of vaginal samples resuspended in the two different media were compared to those obtained from the reference clinician-collected cervical sample from the same woman. hrHPV detection in vaginal self-samples suspended in both media demonstrated a substantial agreement with cervical samples with the three assays under-investigation (0.667<k<0.796). Moreover, the discordances between vaginal self-samples collected from the same woman were found only in cases of normal cytology or low-grade cytological lesions and were generally related to low hrHPV viral loads as indicated by the quantitative HPV OncoPredict assay (6.24E+02 copies/10,000 cells). This study demonstrated a very good agreement between cervical and vaginal self-collected samples suspended in ThinPrep®PreservCyt® and eNat®, suggesting that the latter could represent a good alternative medium in HPV screening programs based on self-collection.

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“…The presence of high-risk human papillomavirus (hrHPV), which might be associated with different degrees of pathophysiology and local inflammation, was detected. To do that, AmpFire ® HPV assay was used according to the user manual instruction, to simultaneously identify either HPV 16 genotype, HPV 18 genotype or fifteen other hrHPV genotypes (31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66 and 68, not individually identified and further referred in this manuscript as HPV others) [ 66 ].…”

Section: Methodsmentioning

confidence: 99%

The Vaginal Microbiota Composition and Genital Infections during and after Pregnancy among Women in Pemba Island, Tanzania

et al. 2022

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We investigated the vaginal microbiota (VMB) composition, prevalence of genital pathogens and their association among pregnant and post-delivery women in Pemba Island, Tanzania. Vaginal swabs were collected from 90 women, at two time points during pregnancy (<20 weeks of gestational age [GA] and ≥20 weeks GA) and once after delivery, when possible. IS-pro assay was used for VMB characterization. Chlamydia trachomatis (CT), Neisseria gonorrhea (NG), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG) and human papillomavirus (HPV) were detected by qPCRs. VMB were mostly Lactobacillus dominant during pregnancy and non-Lactobacillus dominant post-delivery. A significant decrease in VMB richness was observed during pregnancy among paired and unpaired samples. Shannon diversity was significantly lower during pregnancy than post-delivery among unpaired samples. Klebsiella species and Streptococcus anginosus were the most commonly identified pathobionts at all timepoints. A high abundance of pathobionts was mostly seen in women with non-Lactobacillus dominant VMB. At ≥20 weeks GA timepoint during pregnancy, 63.0% of the women carrying one or more genital pathogen (either HPV, CT, TV, or MG) had L. iners dominant VMB. NG was not detected pre-delivery. This study contributes evidence on VMB composition, its changes during pregnancy and post-delivery, and their association with pathobionts and genital pathogens.

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Detection of high-risk human papillomavirus (HPV) by the novel AmpFire isothermal HPV assay among pregnant women in Pemba Island, Tanzania

Cited by 14 publications

References 23 publications

Agreement between Xpert and AmpFire tests for high-risk human papillomavirus among HIV-positive women in Rwanda

Agreement between Xpert and AmpFire tests for high-risk human papillomavirus among HIV-positive women in Rwanda

Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep®PreservCyt® for vaginal swabs

The Vaginal Microbiota Composition and Genital Infections during and after Pregnancy among Women in Pemba Island, Tanzania

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