36 research outputs found
Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification
Objectives. We evaluated the performances of Amplix real-time PCR platform developed by Biosynex (Strasbourg, France), combining automated station extraction (Amplix station 16 Dx) and real-time PCR (Amplix NG), for quantifying plasma HIV-1 RNA by lyophilized HIV-1 RNA-based Amplix reagents targeting gag and LTR, using samples from HIV-1-infected adults from Central African Republic. Results. Amplix real-time PCR assay showed low limit of detection (28 copies/mL), across wide dynamic range (1.4–10 log copies/mL), 100% sensitivity and 99% specificity, high reproducibility, and accuracy with mean bias < 5%. The assay showed excellent correlations and concordance of 95.3% with the reference HIV-1 RNA load assay (Roche), with mean absolute bias of +0.097 log copies/mL by Bland-Altman analysis. The assay was able to detect and quantify the most prevalent HIV-1 subtype strains and the majority of non-B subtypes, CRFs of HIV-1 group M, and HIV-1 groups N and O circulating in Central Africa. The Amplix assay showed 100% sensitivity and 99.6% specificity to diagnose virological failure in clinical samples from antiretroviral drug-experienced patients. Conclusions. The HIV-1 RNA-based Amplix real-time PCR platform constitutes sensitive and reliable system for clinical monitoring of HIV-1 RNA load in HIV-1-infected children and adults, particularly adapted to intermediate laboratory facilities in sub-Saharan Africa
Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial
BACKGROUND:
Passive immunotherapy using hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2, derived from recovered donors, is a potential rapidly available, specific therapy for an outbreak infection such as SARS-CoV-2. Findings from randomised clinical trials of hIVIG for the treatment of COVID-19 are limited.
METHODS:
In this international randomised, double-blind, placebo-controlled trial, hospitalised patients with COVID-19 who had been symptomatic for up to 12 days and did not have acute end-organ failure were randomly assigned (1:1) to receive either hIVIG or an equivalent volume of saline as placebo, in addition to remdesivir, when not contraindicated, and other standard clinical care. Randomisation was stratified by site pharmacy; schedules were prepared using a mass-weighted urn design. Infusions were prepared and masked by trial pharmacists; all other investigators, research staff, and trial participants were masked to group allocation. Follow-up was for 28 days. The primary outcome was measured at day 7 by a seven-category ordinal endpoint that considered pulmonary status and extrapulmonary complications and ranged from no limiting symptoms to death. Deaths and adverse events, including organ failure and serious infections, were used to define composite safety outcomes at days 7 and 28. Prespecified subgroup analyses were carried out for efficacy and safety outcomes by duration of symptoms, the presence of anti-spike neutralising antibodies, and other baseline factors. Analyses were done on a modified intention-to-treat (mITT) population, which included all randomly assigned participants who met eligibility criteria and received all or part of the assigned study product infusion. This study is registered with ClinicalTrials.gov, NCT04546581.
FINDINGS:
From Oct 8, 2020, to Feb 10, 2021, 593 participants (n=301 hIVIG, n=292 placebo) were enrolled at 63 sites in 11 countries; 579 patients were included in the mITT analysis. Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7; the adjusted OR was 1·06 (95% CI 0·77–1·45; p=0·72). Infusions were well tolerated, although infusion reactions were more common in the hIVIG group (18·6% vs 9·5% for placebo; p=0·002). The percentage with the composite safety outcome at day 7 was similar for the hIVIG (24%) and placebo groups (25%; OR 0·98, 95% CI 0·66–1·46; p=0·91). The ORs for the day 7 ordinal outcome did not vary for subgroups considered, but there was evidence of heterogeneity of the treatment effect for the day 7 composite safety outcome: risk was greater for hIVIG compared with placebo for patients who were antibody positive (OR 2·21, 95% CI 1·14–4·29); for patients who were antibody negative, the OR was 0·51 (0·29–0·90; pinteraction=0·001).
INTERPRETATION:
When administered with standard of care including remdesivir, SARS-CoV-2 hIVIG did not demonstrate efficacy among patients hospitalised with COVID-19 without end-organ failure. The safety of hIVIG might vary by the presence of endogenous neutralising antibodies at entry.
FUNDING:
US National Institutes of Health
Infrequent detection of human papillomavirus infection in head and neck cancers in the Central African Republic: a retrospective study
Infrequent detection of human papillomavirus infection in head and neck cancers in the Central African Republic: a retrospective study
Abstract We carried out a retrospective study on the prevalence of HPV and genotype distribution by nested PCR and nucleotide sequencing analysis, in formalin-fixed, paraffin-embedded biopsies of 135 head and neck cancers (HNC) and 29 cervical cancers received between 2009 and 2017 for diagnosis at the Laboratoire National de Biologie Clinique et de Santé Publique of Bangui, the capital city of the Central African Republic. One oropharyngeal squamous cell carcinoma sample was positive for HPV type 16. The overall HPV prevalence in HNC biopsies was 0.74% (95% CI: 0.0–2.2). Among the 29 cervical cancer samples, 19 (65.5%; 95% CI: 48.2–82.8) were positive for HPV. These results indicate that HNC are infrequently associated with HPV infection in the Central African Republic
Recommended from our members
Children’s Understanding of Economic Inequality
A plethora of reports by governmental agencies, think tanks, international organizations, and newspapers chart the development and stubborn persistence of income inequality in the UK. Epidemiological research has shown that societies with greater income inequality score lower than more equal societies in common public health indicators (e.g., morbidity, infant mortality; Wilkinson & Pickett, 2006), but also well-being and mental health (Pickett & Wilkinson, 2015). Thus, income inequality has adverse effects for individuals and societies at large. The purpose of this seminar series is to understand how children reason about inequalities at societal and interpersonal levels and how inequality affects them at a personal level. Looking at the developmental origins of the understanding of inequality may help us to combat acceptance of large differences in income inequality.
Some research has explored children’s acceptance of inequality at a societal level and in interpersonal interactions. At an explicit level, seminal work found that children do not support income inequalities based on occupation until they are over 8 years of age (Emler & Dickinson, 1985). More recent research also suggests that 8-year-old children are less likely to support school segregation based on income than are 14-year-old children (Tenenbaum, Leman, Aznar, Duthie, & Killen, 2018). Thus, acceptance of income inequality seems to increase throughout middle childhood and adolescence.
Given when these data were conducted on children’s understanding of income inequality, this project will examine whether children continue to support income inequality. We are particularly interested if opinions about key worker positions have changed after the lockdown. In the original study (Emler & Dickinson, 1985), children were asked about bus drivers, teachers, road sweepers, and doctors. They argued that doctors should be paid more because they have more education. In the present study, we will ask about the following occupations: Our full collection will be doctor, engineer, teacher, bank manager, bus driver, rubbish
All the necessary information is included in the uploaded OSF word doc
Potential for False-Positive Results with Serological Assays for HIV in Central Africa: Implications for the HIV Serodiagnosis Algorithm According to the 2015 Consolidated WHO Recommendations for Resource-Constrained Countries
Analytical performances of simultaneous detection of HIV-1, HIV-2 and hepatitis C- specific antibodies and hepatitis B surface antigen (HBsAg) by multiplex immunochromatographic rapid test with serum samples: A cross-sectional study
High predictive efficacy of integrase strand transfer inhibitors in perinatally HIV-1-infected African children in therapeutic failure of first- and second-line antiretroviral drug regimens recommended by the WHO
Usefulness of simultaneous screening for HIV-specific and HCV-specific antibodies and HBsAg by a capillary-based multiplex rapid diagnostic test to strengthen linkage-to-care in sub-Saharan patients attending sexually transmitted infection clinic
Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification
International audienc
