Performance evaluation of the new Access HIV Ag/Ab combo assay on the DxI 9000 Access Immunoassay Analyzer.

Fourth-generation HIV immunoassays have been developed to reduce the window period of detection during seroconversion period, allowing for the detection of early and established infections. The aim of this work was to evaluate a newly developed assay, Access HIV Ag/Ab combo on the novel high throughput DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). The assay allows for simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and HIV-1/2 antibodies. Assay performance was compared to two gold standard assays, the Abbott Architect HIV Ag/Ab Combo and Roche Elecsys HIV Duo, and assessed in a multicenter study, using a wide panel of samples (n > 9000, clinical samples and viral lysates) representative of genetic diversity for both antibodies and antigens, early phases of infection, negative, and cross-reacting samples. The clinical sensitivity was 100 % for clinical samples as well as for viral lysates. Data on viral lysates and early detection on seroconversion panels showed a better result with the Access assay. Analytical sensitivity showed a limit of p24 detection determined around 0.2 IU/mL. The overall specificity was 99.91 %, and no interference was found using the potentially cross-reactive samples. In conclusion, the Access HIV Ag/Ab combo assay demonstrated its ability for accurate diagnosis of chronic as well as primary HIV infections on the DxI 9000 Analyzer, despite the high level of genetic diversity of these viruses.

[Specific diagnosis and follow-up of HIV-1 group O infection: RES-O data]. / Diagnostic spécifique et prise en charge des infections par un VIH-1 groupe O: données de RES-O.

INTRODUCTION: HIV-1 group O (HIV-O), mainly found in Cameroon, has a very high genetic diversity with consequences on the diagnosis and treatment of patients, requiring the development of specific tools. OBJECTIVE: We present the currently available tools for the specific detection of HIV-O and its therapeutic monitoring, and the first RES-O data, a French network for the identification and monitoring of patients infected by HIV-O. METHOD: The diagnosis of infection was confirmed by group-specific envelope serotyping. The viral load was assessed by a specific technique, LTR-O, developed in the laboratory and compared to the nonspecific kit RealTime HIV-1 (Abbott). The sequencing of antiretroviral target regions (Protease, Reverse Transcriptase (RT), Integrase and Gp41), was performed by specific primers. The analysis of resistance mutations was performed with the ANRS algorithm used for HIV-M. RESULTS: HIV-O infection was confirmed for 117 patients. Measuring viral load showed the two techniques were equivalent, but with a tendency to under-quantification for the Abbott technique greater than 1 log for 5% of samples. 70 to 100% of the studied strains had at least 10 mutations in the Protease, four 4 in the RT, and one in Gp41, resulting in a natural genotypic resistance to some anti-retroviral molecules. DISCUSSION: The diagnosis and monitoring of HIV-O infection is now possible. However, the impact of this variant's natural polymorphism on response to treatment remains undocumented.

Sonda de Foley cervical versus misoprostol vaginal para o preparo cervical e indução do parto: um ensaio clínico randomizado / Cervical Foley catheter versus vaginal misoprotol for cervical ripening and induction of labor: a randomized clinical trial

OBJETIVO: comparar a efetividade da sonda de Foley com o uso de misoprostol vaginal para o preparo cervical e indução do parto. MÉTODOS: ensaio clínico randomizado, não cego, realizado entre Janeiro de 2006 a Janeiro de 2008. Foram incluídas 160 gestantes com indicação de indução do parto, divididas em dois grupos: 80 para o uso da sonda de Foley e 80 para misoprostol vaginal. Os critérios de inclusão foram: idade gestacional a partir de 37 semanas, feto único, vivo, cefálico e índice de Bishop igual ou menor que 4. Foram excluídas pacientes com cicatriz uterina, ruptura de membranas, peso fetal estimado maior que 4000g, placenta prévia, corioamnionite e condições que impunham o término imediato da gestação. Os testes estatíticos utilizados foram Mann-Whitney, x² de Pearson ou exato de Fischer, sendo considerado significativo se menor qeu 0,005. RESULTADOS: o misoprostol desencadeou mais vezes o parto de forma expontânea (50,0 versus 15,0% para o Foley p<0,001) e menor uso de ocitocina (41,2 versus 76,2), sendo que esse grupo apresentou mais taquissistolia (21,2 versus 5,%). A sonda de Foley causou mais desconforto à paciente (28,7 versus 1,2%). Não houve diferenças em relação ao tempo necessário para evolução do índice de Bishop (20,69 versus 21,36 horas), para o desencadeamento do parto (36,42 versus 29,57 horas) e nas taxas de cesáreas (51,2 versus 42,5%). Não houve diferenças significativas no desempenho perinatal, com frequências semelhantes de cardiotocografia anormal (20,0 versus 21,2%), presença de mecônio (13,7 versus 17,5%) e necessidade de UTI neonatal (3,7 versus 6,2%). CONCLUSÕES: o uso da sonda de Foley apresentou efetividade semelhante ao misoprostol para o preparo cervical, porém foi menos efetivo para o desencadeamento espontâneo do parto. Nossos resultados apoiam a recomendação de seu uso para o preparo cervical, sobretudo em pacientes portadoras de uma cicatriz de cesárea.(AU)

Census and analysis of persistent false-negative results in serological diagnosis of human immunodeficiency virus type 1 group O infections.

Human immunodeficiency viruses (HIV) have a high level of genetic diversity. The outlier variants of HIV type 1 (HIV-1) group O are distantly related to HIV-1 group M. Their divergence has an impact on serological diagnosis, with a risk of false-negative results. In this study, we report 20 failure cases, involving patients with primary or chronic infection, in France and Cameroon between 2001 and 2008. Our results indicate that some assays detected group O infection much less efficiently than others. Two major reasons for these false-negative results were identified: the presence or absence of a group O-specific antigen (and the designed sequence) for the detection of antibodies and the greater envelope variability of group O than of group M strains. This study highlights the complexity of screening for these divergent variants and the need to evaluate test performance with a large panel of strains, due to the extensive diversity of group O variants.

Successful treatment of metronidazole- and albendazole-resistant giardiasis with nitazoxanide in a patient with acquired immunodeficiency syndrome.

A case of metronidazole- and albendazole-resistant giardiasis in a patient with the acquired immunodeficiency syndrome was successfully treated with nitazoxanide (1.5 g twice a day for 30 days). Animal studies and in vitro assays showed that the isolate was resistant to both metronidazole and albendazole and susceptible to nitazoxanide.

Metronidazole and albendazole susceptibility of 11 clinical isolates of Giardia duodenalis from France.

The metronidazole and albendazole susceptibility of 11 clinical isolates of Giardia duodenalis from France was determined using a neonatal mouse model and compared with the outcome in patients after standard metronidazole therapy (0.75 g/day for 5 days). All isolates found to be clinically resistant to metronidazole (4/11) exhibited an ID50 > 120 mg/kg in the mouse model. This therefore appears to be a suitable animal model in which to explore drug failures in human giardiasis.