Obstetric management does not influence vertical transmission of HCV infection: results of the ALHICE group study.

OBJECTIVE: To investigate the impact of variation in obstetric practice during labor and childbirth upon the rate of neonatal transmission of HCV. METHODS: Pregnant mothers were included in this prospective study from six hospitals in Southern France on the basis of positive HCV serology. Data recorded for the study included maternal factors, delivery details and laboratory data concerning mother and child. Pediatric follow-up was documented for a minimum of 1 year and for up to 2 years for children with circulating HCV RNA. RESULTS: Two hundred and fourteen mother-child pairs were investigated. HIV/HCV co-infected mothers had a rate of HCV transmission significantly higher (11%) than that observed for mono-infected mothers (3.8%) (odds ratio=3.08 [95% CI:0.95 to 9.99] p=0.05). When the HCV viral load was greater than or equal to 6 log copies/ml, the transmission rate was 14.3% [95% CI:5.4-28.5], this representing a risk of transmission four times higher than for women with a lower viral load (OR=4 [95% CI:1.3-12.4]). Among co-infected mothers, the risk of transmission was significantly increased even when the load was less than 6 log copies/ml (p=0.006). Risk factors were identified related to labor (duration and induction type); the birth process (rupture of the amniotic sac, complete opening of the sac, appearance of the amniotic fluid); fetal characteristics (prematurity) and obstetric maneuvers (instrumental extractions, spontaneous or induced perineal trauma) and none of these factors were associated with an increased rate of HCV maternal-fetal transmission. CONCLUSIONS: HCV infection does not appear to be a legitimate indication for modifying obstetric practices with regards to type of induction, monitoring of labor, route of delivery, fetal and perineal obstetric maneuvers or care of the newborn in the delivery room.

Detection of antibodies to hepatitis B core antigen using the Abbott ARCHITECT anti-HBc assay: analysis of borderline reactive sera.

Routine use of the automated chemiluminescent microparticle immunoassay Abbott ARCHITECT anti-HBc for diagnosis of hepatitis B is limited in case of borderline reactive sera with low signal close to the cut-off index. In order to determine the significance of anti-HBc detection when borderline reactivity occurs using the ARCHITECT anti-HBc assay, a comparative study was designed. 3540 serum samples collected over a 2-month period in the hospital of Nice were examined for markers of HBV infection (HBsAg, anti-HBs and anti-HBc). One hundred seven samples with sufficient volume and with borderline reactivity by the ARCHITECT assay were tested by two other anti-HBc assays, a microparticle enzyme immunoassay (MEIA, AxSYM Core, Abbott Laboratories, IL, USA) and an enzyme linked fluorescent assay (ELFA, VIDAS Anti-HBc Total II, bioMérieux, Lyon, France). Only 46 samples were confirmed by the AxSYM and the VIDAS assays. Additional serological information linked to patient history showed that the remaining samples (61) were false positives (11), had low titer of anti-HBc antibodies (13), or were inconclusive (37). This comparative study highlighted the existence of a grey zone around the cut-off index. Confirmative results through a different immunoassay are needed to confirm the diagnosis of HBV on borderline reactive sera using the ARCHITECT anti-HBc assay.

Expertise of French laboratories in detection, genotyping, and quantification of hepatitis C virus RNA in serum.

Before initiating new large-scale therapeutic trials for hepatitis C virus (HCV)-infected patients, the French Health Authorities for HCV research decided to organize an evaluation of the expertise of laboratories that could be engaged to undertake molecular biology assays in such trials; 21 experienced laboratories participated in this national evaluation of laboratory expertise, which was performed in two successive rounds. The first round evaluated the laboratories for their abilities to detect HCV RNA in serum, determine genotypes, and quantify HCV RNA loads. The results observed by qualitative assays for HCV RNA detection were 100% sensitivity and 100% specificity for all laboratories. The genotyping results were 100% concordant for 9 laboratories and greater than 90% for 10 laboratories. By contrast, large coefficients of variation were observed for quantitative determination of HCV RNA loads, leading to a second round with standardized quantitative assays only. The dispersion of the results was larger by the AMPLICOR HCV Monitor assay than by the branched-DNA assay (mean coefficients of variation, 57.4 and 16.9%, respectively). In the majority of cases, discrepancies between the results of the two tests were found for samples with high viral loads. These results indicate the usefulness of validating, by controlling for expertise, both the reliabilities of laboratories involved in multicenter work and the standardized assays chosen for use in the evaluation of the biological impacts of new therapies.