Highly oncogenic human papillomavirus (HPV) infections are responsible for 7.7 % of cancers in developing countries, mainly cervical cancer. The incidence of this emerging cancer is steadily increasing in sub-Saharan Africa, with more than 75,000 new cases and close to 50,000 deaths a year, a toll further increased by HIV infection. According to the World Health Organization, cervical cancer will kill more than 443,000 women per year worldwide by 2030, nearly 90 % of them in sub-Saharan Africa. This increase in cervical cancer incidence in Africa is now counteracting the progress made by African women in reducing maternal mortality and increasing longevity. Nevertheless, cervical cancer is a potentially preventable noncommunicable disease that can be averted or halted by primary (vaccination), secondary (early diagnosis of situations at risk), and tertiary (early diagnosis of proven cases of cervical neoplasia) prevention. The close links between HIV and HPV justify linking cervical cancer prevention, screening, and management programs with AIDS programs as part of the ''90-90-90'' initiative of the UNAIDS, both nationally and regionally. Innovative strategies based on effective, rapid, inexpensive, and mobile screening tools, including at best molecular biology as well as vaccination and awareness programs, should be rapidly implemented and evaluated in sub-Saharan Africa.
Objectives
We herein assessed the analytical performances of the antigen-rapid diagnosis test (Ag-RDT)
SIENNA™ COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab)
(Salofa Oy, Salo, Finland), targeting the SARS-CoV-2 N nucleocapsid protein, for the diagnosis of COVID‐19 in hospitalized patients with suspect SARS‐CoV‐2 infection, by reference to real-time RT-PCR (rRT-PCR).
Methods
Nasopharyngeal swabs were collected from patients with COVID-19-like illness during the second epidemic wave in Paris, France, among which 100 and 50 were positive and negative for RNA SARS-CoV-2, respectively.
Results
Overall, the Ag-RDT showed high sensitivity, specificity, positive and negative predictive values of 90.0%, 100.0%, 100.0% and 98.1%, respectively, as well as high or almost perfect agreement (93.3%), reliability assessed by Cohen's κ coefficient (0.86), and accuracy assessed by Youden’s J index (90%) to detect SARS-CoV-2. The analytical performances of the Ag-RDT remained high in the event of significant viral excretion (
i.e.
, N gene C
t
values ≤ 33 by reference rtRT-PCR), while the sensitivity of the Ag-RDT dropped to 69.6% with low or very low viral shedding (C
t
> 33).
Conclusions
The SIENNA™ Ag-RDT presents excellent analytical performances for viral loads ≤ 33 C
t
, classically corresponding to situations of symptomatic COVID-19 and/or proven contagiousness.
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