Accuracy of Curable Sexually Transmitted Infections and Genital Mycoplasmas Screening by Multiplex Real-Time PCR Using a Self-Collected Veil among Adult Women in Sub-Saharan Africa

Abstract

Background. Sexually transmitted infections (STIs) are highly prevalent in sub-Saharan Africa. Genital self-sampling may facilitate the screening of STIs in hard-to-reach remote populations far from large health care centers and may increase screening rates. The cross-sectional GYNAUTO-STI study was carried out to assess the performance of a novel genital veil (V-Veil-Up Gyn Collection Device, V-Veil-Up Pharma, Ltd., Nicosia, Cyprus) as a genital self-sampling device to collect genital secretions to diagnose STIs by molecular biology as compared to reference clinician-collected genital specimens, in adult African women. Methods. Adult women living in N’Djamena, the capital city of Chad, were recruited from the community and referred to the clinic for women’s sexual health “La Renaissance Plus”. A clinician obtained an endocervical specimen using flocked swab. Genital secretions were also obtained by self-collection using veil. Both clinician- and self-collected specimens were tested for common curable STIs (including Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis) and genital Mycoplasma spp. by multiplex real-time PCR (Allplex™ STI Essential Assay, Seegene, Seoul, South Korea). Test positivities for both collection methods were compared by assessing methods agreement, sensitivity, and specificity. Results. A total of 251 women (mean age, 35.1 years) were prospectively enrolled. Only seven (2.8%) women were found to be infected with at least one common STIs [C. trachomatis: 3 (1.2%), N. gonorrhoeae: 1 (0.4%), M. genitalium: 4 (1.6%) and T. vaginalis: 1 (0.4%)], while the prevalence of genital mycoplasmas was much higher (54.2%) with a predominance of Ureaplasma parvum (42.6%). Self-collection by veil was non-inferior to clinician-based collection for genital microorganisms DNA molecular testing, with “almost perfect” agreement between both methods, high sensitivity (97.0%; 95%CI: 92.5-99.2%), and specificity (88.0%; 95%CI: 80.7-93.3%). Remarkably, the mean total number of genital microorganisms detected per woman was 1.14-fold higher in self-collected specimens compared to that in clinician-collected specimens. Conclusions. Veil-based self-collection of female genital secretions constitutes a convenient tool to collect in gentle way cervicovaginal secretions for accurate molecular detection of genital bacteria. Such sampling procedure could be easily implemented in STIs clinics in sub-Saharan Africa.

The Global Burden of Sexually Transmitted Infections Estimated from 1990 to 2019

“…The STI burden is serious in sub-Saharan Africa countries, which account for 60% of global disease-adjusted life years. The ASR of several countries like Mozambique, Ethiopia, and Liberia is high, may because Sub-Saharan Africa still faces a multiple disease burden now, especially AIDS 22 ; remote areas far away from primary health care services are di cult to achieve well-developed health services, and screening covers a small area of people 30 . Sub-Saharan Africa had a high YLLs proportion, meaning that the leading cause of heavy DALY burden in the region is premature deaths attributable to STIs.…”

Self-Sampling Interventions for Sexually Transmitted Infections in Women: A Scoping Review Protocol

“…Other barriers include stigmatization and judgement associated with issues of sexual ill-health (8,20). Moreover, some women nd invasive genital examinations embarrassing and uncomfortable and as such procrastinate seeking medical assistance, and as such risk disease complications (11,14). Innovative interventions that alleviate such barriers are necessary to facilitate management of the STI pandemic.…”

“…Innovative interventions that alleviate such barriers are necessary to facilitate management of the STI pandemic. Self-sampling interventions offer privacy and convenience, and thus have the ability to alleviate these barriers (14,20).…”

“…Furthermore, in resource-limited settings where access to healthcare facilities is limited, this approach places these populations at a disadvantage (6). According to various research, routine screening of STIs is imperative for proper management and control (6,14). High income countries use various interventions to screen both symptomatic and asymptomatic infections, thus improve the management of STIs (6).…”

“…In selfsampling, specimen collection kits are issued to individuals to collect their own specimens either at home or at a healthcare facility (10). The convenience and con dentiality offered by self-sampling interventions, make it ideal to facilitate screening and broaden STI services to populations with limited access to healthcare resources (14). Self-sampling also allows for the screening of asymptomatically infected individuals, that would otherwise go undiagnosed and untreated, and thus risk complication of disease (6).…”