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To control the spread of the coronavirus disease 2019 (COVID‐19) epidemics, it is necessary to have easy‐to‐use, reliable diagnostic tests available. The nasopharyngeal sampling method being often uncomfortable, nasal sampling could prove to be a viable alternative to the reference sampling method. We performed a multicentre, prospective validation study of the COVID‐VIRO® test, using a nasal swab sampling method, in a point‐of‐care setting. In addition, we performed a multicentre, prospective, and usability study to validate the use of the rapid antigen nasal diagnostic test by laypersons. In March 2021, 239 asymptomatic and symptomatic patients were included in the validation study. Compared with reverse‐transcription polymerase chain reaction on nasopharyngeal samples, the sensitivity and specificity of the COVID‐VIRO® Antigen test combined with a nasal sampling method were evaluated as 96.88% and 100%, respectively. A total of 101 individuals were included in the usability study. Among these, 99% of the participants rated the instructions material as good, 98% of the subjects executed the test procedure well, and 98% of the participants were able to correctly interpret the test results. This study validates the relevance of COVID‐VIRO® as a diagnostic tool from nasal specimens as well as its usability in the general population. COVID‐VIRO® diagnostic performances and ease of use make it suitable for widespread utilization.

The control of the COVID-19 epidemics has been one global health priorities for the last 2 years. To that end, more reliable and easy-to-use, regardless of age, diagnostic tests are necessary. Considering that, we evaluated an innovative two-step self-test, the AAZ COVID-VIRO ALL IN®, switching from the classic nasal swab to a nasal sponge. We performed a multicenter study, on 124 adults and children, in a point-of-care setting. Sensitivity, specificity and overall acceptance of the COVID-VIRO ALL IN® self-test compared to reverse transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal samples were of 93.0%, 100%, and 97.5%, respectively. We then performed a multicenter, usability study to evaluate the ease of use of COVID-VIRO ALL IN® on 68 laypersons adults. A vast majority of participants correctly executed and interpreted the test. The usability was then specifically investigated on 40 children and teenagers, comparing COVID-VIRO® first generation to the new COVID-VIRO ALL IN®. They all found COVID-VIRO ALL IN® more comfortable and easier to use. For young children, the new self-test seems safer (less risk of trauma and no liquid exposure), and faster than saliva-based RT-PCR. Moreover, the COVID-VIRO ALL IN® can easily be adapted as a multiplex self-test for other respiratory viruses, opening new perspectives of simultaneous, rapid and massive detection of respiratory infections, especially among vulnerable populations like children and elderly people.

The control of the COVID-19 epidemics has been one of top global health priorities for the last eighteen months. To that end, more reliable and easy-to-use diagnostic tests are necessary. Young children are still not eligible to vaccination and it is important to find a way to easily test this key population regularly. With that in mind, we evaluated a new innovative easy two-step self-test named COVID-VIRO ALL IN® developed by AAZ that uses a sampling nasal sponge instead of a classic nasal swab. Mirroring the previous study conducted on the first generation of COVID-VIRO® antigenic self-test, we first performed a multicentre, prospective study on 124 adults and children, in a point-of-care setting. Sensitivity, specificity and overall acceptance of the COVID-VIRO ALL IN® antigen self-test compared to RT-PCR on nasopharyngeal samples were evaluated at 93.02%, 100% and 97,5%, respectively. We then performed a multicentre, prospective, usability study to evaluate the ease of use of COVID-VIRO ALL IN® in real life on 68 laypersons, all adults. Globally, 99% of them considered the instructions material good, 98% executed the procedure well, and all of them interpreted the results correctly. The usability was then specifically investigated on 40 children and teenagers participants, comparing both COVID-VIRO® first generation and the new COVID-VIRO ALL IN®. All of them found COVID-VIRO ALL IN® much easier to use and much more comfortable. For young children, the COVID-VIRO ALL IN® self-test appears to be safer (less risk of trauma compare to nasal swabs and no liquid exposure) easier to use than classic COVID self-tests and giving immediate result which is not the case for RT-PCR done on saliva samples (currently done in routine for kids in French schools). It could be an adapted tool for future mass screening campaigns in schools or at home under adult supervision for kids from the age of 3.

Introduction Nous avons decrit dans une precedente enquete transversale (phase 1 : 2017-2019) une forte prevalence de l’infection anale a Papillomavirus Humains a haut risque (HR-HPV) 3 mois apres l’initiation de la PrEP dans une population de HSH. La presente etude (phase 2 : 2019–2020) a pour objectif d’estimer la prevalence de l’infection anale a HPV, le taux d’incidence, de persistance et de clairance de l’infection, ainsi que l’evolution des pratiques sexuelles a risque chez ces memes patients, 12 a 18 mois apres l’initiation de la PrEP. Materiels et methodes Des prelevements anaux ont ete collectes chez des HSH sous PrEP, suivis longitudinalement. Ces prelevements ont ensuite ete analyses par PCR multiplex en temps reel permettant la detection de 28 HPV. Les informations cliniques, sociodemographiques et comportementales ont ete collectees. Resultats Dans la phase 1, 61 HSH (âge moyen : 36,1 ans) prenant la PrEP ont ete inclus. Les prevalences globales de l’infection anale a HPV et a HR-HPV etaient respectivement de 93,4 % (IC 95 % : 87,2–99,6) et de 81,9 % (IC a 95 % : 72,3–91,6). HPV-33 etait majoritaire. Dans la phase 2, 31 HSH (âge moyen : 39,2 ans), prenant la PrEP depuis au moins 1 an, ont ete a nouveau preleves. Les prevalences de l’infection anale a HPV et a HR-HPV etaient respectivement de 83,9 % (IC a 95 % : 70,9–96,8) et de 54,8 % (IC a 95 % : 37,3–72,4). Apres un an de suivi, HPV-56 (22,6 %) etait le plus detecte. HPV-33 qui etait le plus detecte a l’inclusion, etait cette fois, le deuxieme genotype a haut-risque le plus detecte, avec le HPV-51 (16,1 %). HPV-16 (12,9 %) etait present chez 4 HSH tandis que le HPV-18 (3,2 %) n’etait que faiblement represente. Les taux de clairance naturelle variaient de 33 % a 100 % selon les genotypes, avec 60 % pour HPV-16 et 50 % pour HPV-18. HPV-56, non cible par le vaccin Gardasil-9®, etait le genotype oncogene ayant le plus fort taux d’incidence (15,4 %), suivi par les genotypes HPV-51 (13,9 %), HPV-45 (11,1 %), HPV-16 et HPV-68 (7,7 %), HPV-59 (6,6 %), HPV-52 (3,8 %), HPV-58 (3,7 %) et HPV-39 (3,9 %). Aucune nouvelle infection par les autres genotypes a haut-risque (HPV-18, -31, -33 et -35) n’a pu etre observee. D’autre part, avec des taux moyens de clairance et de persistance, respectivement de 60,2 % (±29,8 %) et de 36,4 % (±30,4 %), la majorite des infections anales a HR-HPV detectee a l’inclusion etait des infections transitoires. Bien que la majorite des HSH presentait, apres 1 an de PrEP, une baisse generale du nombre de partenaires sexuels differents, la plupart d’entre eux est cependant passee d’une utilisation discontinue du preservatif a une non utilisation categorique, augmentant ainsi le risque de nouvelles infections. Conclusion Bien que la majorite des infections a HR-HPV observee a l’initiation de la PrEP etait transitoire, les taux de persistance sont relativement hauts, associes aux fort taux d’incidence de HR-HPV non cibles par le vaccin Gardasil-9®. Ces donnees permettent de mieux comprendre l’histoire naturelle des infections a HPV dans cette population a risque de cancers HPV-induits.

Background We herein assess the HPV detection and HPV-related cervical lesions in immigrant African women living in France. Methods In 2018, immigrant African adult women attending for sexual health and HIV care a French healthcare facility, were included and subjected to endocervical swabs and Pap smear. HPV DNA was detected by multiplex real-time PCR (AnyplexTM II HPV28, Seegene, Seoul, South Korea). Results 50 African immigrant women (mean age, 41.7) residing in France for an average of 10.7 years (range 1–32), including 74.0% of HIV-positive and 26.0% of HIV-negative, were prospectively included. HPV prevalence was 68.0%, with 56.0% of HR-HPV and 24.0% of multiple HPV. Unexpectedly, the non-vaccine HR-HPV-68 (20.0%) was the predominant genotype, followed by the Gardasil-9® vaccine HR-HPV-58 (14.0%). HPV-16 and HPV-18 were respectively detected in 6.0% and 10.0%. HIV-infected women were more infected with HR-HPV (62.2%) and multiple HR-HPV (16.2%) than HIV-negative women (38.4% and 7.7%, respectively), (P=0.19 and P=0.66, respectively). Most women (84.0%) showed normal cytology, but 16.0% exhibited cervical abnormalities, including 6.0% of Low-grade Squamous Intraepithelial Lesions (LSIL) and Abnormal Squamous Cells with Unknown Significance (ASCUS), and 4.0% of High-grade Squamous Intraepithelial Lesions (HSIL). HPV-16 and HPV-18 were detected in one woman with HSIL. Finally, 87.5% of the study women with cervical abnormalities were HIV-positive, while only one HIV-negative woman showing cervical abnormalities. Conclusion These findings highlight the unsuspected high burden of cervical HR-HPV infections often associated with cervical abnormalities in the first-generation immigrant women originating from sub-Saharan Africa and residing in France. These observations also point out the atypical epidemiological profile of cervical HPV infection with a rare and non-vaccine high-risk genotype being the most detected HPV, raising thus a concern about the low predictive efficacy of the Gardasil-9® vaccine in the prevention of the main genotypes circulating in these specific population residing in France. Disclosure No significant relationships.

Background We assessed the prevalence and risk factors of anal and oral high-risk (HR) human papillomavirus (HPV) infection in human immunodeficiency virus–uninfected men who have sex with men (MSM) and take preexposure prophylaxis (PrEP) in France. Methods Anal and oral samples were screened by multiplex real-time polymerase chain reaction (Anyplex II HPV 28; Seegene) for HPV DNA. Results A total of 61 unvaccinated MSM (mean age, 36.1 years) were enrolled. Anal HPV and HR-HPV prevalences were 93.4% and 81.9%, respectively, and oral HPV and HR-HPV prevalences, 33.9% and 19.6%, respectively. HR-HPV type 33 was the most detected genotype, in both anal and oral samples. Among MSM, 68.8% carried ≥1 anal HPV type targeted by the 9-valent Gardasil-9 vaccine; all oral HPV-positive samples carried ≥1 strain included in the vaccine. Condomless receptive anal intercourse and history of anal gonorrhea were the main factors associated with increased risk for anal HPV infection (adjusted odds ratio, 10.4) and anal infection with multiple HR-HPV genotypes (5.77), respectively. Conversely, having had, French MSM using PrEP are at high risk for both anal and oral carriage of HR-HPV. Although PrEP alone constitutes a promising tool for reducing and preventing HIV in MSM, it remains necessary to associate PrEP with sexual health interventions.

Introduction Les hommes ayant des relations sexuelles avec d’autres hommes (HSH) beneficient maintenant d’une prophylaxie de pre-exposition (PrEP) contre le VIH. En 2018, une enquete descriptive transversale a ete menee pour estimer la prevalence de l’infection a Papillomavirus Humains a haut risque (HR-HPV) aux niveaux anal et oral, ainsi que les facteurs de risque associes, chez des jeunes HSH sous PrEP vivant en France. Materiels et methodes Des prelevements anaux et oraux et des informations cliniques ont ete collectes chez des HSH sous PrEP, inclus prospectivement. Les prelevements ont ete analyses par PCR multiplex en temps reel grâce au systeme Anyplex ™ II HPV 28 (Seegene, Seoul, Coree du Sud) permettant la detection de l’ADN et le genotypage de 28 HPV [9 bas-risques (HPV −6, −11, −40, −42, −43, −44, −53, −54 et −70), 13 haut-risques (HR-HPV −16, −18, −31, −33, −35, −39, −45, −51, −52, −56, −58, −59 et −68) et 6 potentiellement carcinogenes (HPV −26, −61, −66, −69, −73 et −82)]. Resultats Au total, 61 HSH (âge moyen : 36,1 ans) sous PrEP ont ete inclus. Les prevalences de l’infection anale a HPV et a HR-HPV etaient respectivement de 93,4 % (n = 57 ; IC 95 % : 87,2–99,6) et de 81,9 % (n = 50 ; IC 95 % : 72,3–91,6). Les prevalences orales en HPV et HR-HPV etaient respectivement de 33,9 % (19/56 ; IC 95 % : 21,5–46,3) et de 19,6 % (11/56 ; IC 95 % : 9,2–30,1). HR-HPV-33, un des neufs genotypes couvert par le vaccin prophylactique Gardasil-9®, etait le genotype le plus detecte, a la fois au niveau anal et oral. De plus 68,8 % (n = 42) des HSH etaient infectes au niveau anal par au moins un HPV cible par le Gardasil-9® et 100 % avaient au mois un HPV du Gardasil-9® au niveau oral. Les rapports sexuels anaux receptifs non proteges et les antecedents de gonorrhee anale etaient les principaux facteurs, fortement associes, respectivement, a un risque accru d’infection anal a HPV (aOR : 10,4, IC 95 % : 1,2 a 90,5 %) et d’infection anale a HR-HPV multiples (aOR : 5,77, 95 % IC : 1,7–19,3 %). A l’inverse, le fait d’avoir eu moins de 10 partenaires masculins differents au cours des 12 derniers mois etait associe, a la fois, a une diminution du risque d’infection anale a HPV multiples (aOR : 0,19, IC 95 % : 0,05–0,83 %) et a HR-HPV (aOR : 0,17, 95 % IC : 0,04–0,8 %). D’autre part, aucun facteur de risque n’a pu etre mis en evidence pour le portage oral en HPV dans cette population. Conclusion Les HSH francais utilisant la PrEP courent un risque eleve d’infection a la fois anale et orale a HR-HPV et par consequent, aux cancers anaux et oropharynges lies aux HR-HPV. Il devient des lors, urgent de renforcer les strategies de prevention et d’intervention existantes contre l’infection a VIH et les maladies sexuellement transmissibles, aupres des HSH francais seronegatifs prenant la PrEP.