Social cognition and executive functioning in multiple sclerosis: A cluster-analytic approach.

Multiple sclerosis (MS) is associated with deficits in social cognition, the process underlying social interaction and cognitive function. However, the relationships between executive impairment and social cognition remain unclear in MS. Previous studies exclusively focused on group comparisons between healthy controls and patients with MS, treating the latter as a homogeneous population. The variability of socio- and neurocognitive profiles in this pathology therefore remains underexplored. In the present study, we used a cluster analytic approach to explore the heterogeneity of executive and social cognition skills in MS. A total of 106 patients with MS were compared with 53 healthy matched controls on executive (e.g., working memory) and social cognition (facial emotion recognition and theory of mind) performances. A cluster analysis was then performed, focusing on the MS sample, to explore the presence of differential patterns of interaction between executive and social cognition difficulties and their links to sociodemographic, clinical and cognitive variables. We identified three distinct functional profiles: patients with no executive or social cognition deficits (Cluster 1); patients with difficulties in facial emotion recognition and theory of mind and, to a lesser extent, executive functioning (Cluster 2); and patients with executive functioning difficulties only (Cluster 3). Clinical characteristics (disease duration, disability, fatigue) did not differ between clusters. CONCLUSIONS: These results suggest that there are qualitative differences in the social cognition and executive difficulties that are commonly found among patients with MS. If replicated, the identification of these profiles in clinical practice could allow for more individualized rehabilitation.

Anxiety and depression in patients with multiple sclerosis: The mediating effects of perceived social support.

BACKGROUND: Social support has been identified as a buffering or intervening variable in stressful life events. Research has demonstrated that greater social support is associated with better mental health in multiple sclerosis (MS), but little is known about its links to specific aspects of mental health. We therefore investigated if and how perceived social support modulates depression, anxiety and fatigue in patients with MS. METHODS: We recruited 112 patients with MS from three French hospitals and administered a demographic and clinic interview, and self-report measures of perceived social support (Multidimensional Scale of Perceived Social Support), depression and anxiety (Hospital Anxiety and Depression Scale), and fatigue (Fatigue Severity Scale). We then analyzed the relationships between these domains using path analysis. RESULTS: The causal path model provided an excellent fit for the data (χ2 = 9.8, p = .778, standardized root mean square residual = 0.043, comparative fit index = 1.00). Results indicated that the level of social support from friends is a predictor of anxiety symptomatology. Thus, anxiety may have both a direct and an indirect impact on fatigue and depression levels. CONCLUSIONS: This study highlights the important roles played by perceived social support and anxiety in MS. These should be key pharmacological and non-pharmacological targets for optimizing patient care. (NCT 02-880-553).

Neurocognitive and Psychological Outcomes in Adults With Dextro-Transposition of the Great Arteries Corrected by the Arterial Switch Operation.

BACKGROUND: Neurodevelopmental impairments have frequently been described in children and adolescents with dextro-transposition of the great arteries (d-TGA). The arterial switch operation (ASO) to correct d-TGA has been used for more than 30 years, and more than 90% of these patients now reach adulthood. However, very little is known about their long-term functional outcomes. The present study investigated neurocognitive outcomes and the prevalence of psychiatric disorders in adults with d-TGA corrected by ASO. METHODS: Neurocognitive functioning was comprehensively assessed (general intellectual functioning, language, attention, visual-spatial skills, executive functions, memory) in 67 adults (59.7% men) with d-TGA (aged 22.9 ± 3.4 years) and in 43 healthy individuals. The prevalence of psychiatric disorders, including depression and anxiety, was evaluated using a structured diagnostic interview. We also analyzed patient- and operative-related risk factors associated with outcomes. RESULTS: Compared with the general population and the control group, adults with d-TGA displayed reduced performance in tasks assessing attention, visual-spatial skills, executive functions, and memory (all p < 0.05). Compared with controls, patients had also a higher lifetime prevalence of depression (43% vs 19%, p = 0.008) and anxiety disorders (54% vs 33%, p = 0.025). Predictors of long-term outcomes included gender and parental socioeconomic and educational status (all p < 0.05). CONCLUSIONS: Adults who have undergone a neonatal ASO to correct d-TGA have an increased risk of cognitive deficits and psychiatric disorders. Evaluation of long-term neuropsychological and psychosocial outcomes in early adulthood is a crucial step to anticipate for adapted treatment strategies in adults with congenital heart disease.

Social Cognition Abilities in Patients With Different Multiple Sclerosis Subtypes.

OBJECTIVES: Multiple sclerosis (MS) can be associated with impaired social cognition. However, social cognition skills have never been explored in the different subtypes of MS. The first aim of this study was to examine whether MS subtypes differ on the course of social cognition. The second aim was to explore the relationship between social cognition performances and executive abilities and mood variables. METHODS: Sixty-two patients with MS and 33 healthy matched controls performed experimental tasks assessing facial emotion recognition, theory of mind (ToM), and cognitive functioning, in particular executive functions. RESULTS: Patients differed from controls on both measures of social cognition. On the ToM measures, patients with progressive MS scored significantly lower than healthy participants. Patients with primary progressive MS performed worse than both healthy participants and patients with relapsing-remitting MS on the recognition of fearful facial expressions, while patients with secondary progressive MS performed worse on the recognition of facial expressions of sadness. Patients' social cognition difficulties were correlated with processing speed, working memory, and verbal fluency. CONCLUSIONS: These preliminary results suggested that there may be qualitative differences in social cognition difficulties among the phenotypes. Furthermore, these impairments were related to executive functions, but unrelated to patients' disability or level of depression. These data highlight the need for research to determine the real impact of these deficits on interpersonal relationships among patients and to confirm these disorders in a larger population with progressive forms of MS. (JINS, 2017, 23, 653-664).

Cognitive outcomes and health-related quality of life in adults two decades after the arterial switch operation for transposition of the great arteries.

OBJECTIVE: The study objective was to evaluate the cognitive and psychosocial outcomes of young adults who underwent an arterial switch operation for transposition of the great arteries. METHODS: Sixty-seven adults with transposition of the great arteries (aged 22.9 ± 3.3 years) and 43 healthy subjects matched in age, gender, and educational level participated. Global cognitive functioning, psychologic state, and health-related quality of life were evaluated using validated tools. We analyzed patient-related and procedure-related risk factors associated with cognitive and psychosocial outcomes. RESULTS: Some 69% of patients had an intelligence quotient greater than 85 (normal range, 85-115). Mean full-scale, verbal, and performance intelligence quotients were lower in patients (94.9 ± 15.3, 96.8 ± 16.2, 93.7 ± 14.6, respectively) than in healthy subjects (103.4 ± 12.3, P = .003; 102.5 ± 11.5, P = .033; 103.8 ± 14.3, P < .001, respectively). Cognitive difficulties (intelligence quotient ≤-1 standard deviation) and impairments (intelligence quotient ≤-2 standard deviations) were more frequent in patients than in the general population (31% vs 16%, P = .001; 6% vs 2%, P = .030). Patients with cognitive difficulties had lower educational level (P < .001) and more grade retention at school (P = .007). Patients reported an overall satisfactory health-related quality of life; however, those with cognitive or psychologic difficulties reported poorer quality of life. Predictors of worse outcomes included lower parental socioeconomic and educational status, older age at surgery, and longer hospitalization stay. CONCLUSIONS: Despite satisfactory outcomes in most adults with transposition of the great arteries, a substantial proportion has cognitive or psychologic difficulties that may reduce their academic success and quality of life. Further studies are needed to better understand the long-term outcome of this population to provide prevention, surveillance, and care strategies.

Neuropsychological and Psychiatric Outcomes in Dextro-Transposition of the Great Arteries across the Lifespan: A State-of-the-Art Review.

Advances in prenatal diagnosis, perioperative management, and postoperative care have dramatically increased the population of survivors of neonatal and infant heart surgery. The high survival rate of these patients into adulthood has exposed the alarming prevalence of long-term neuropsychological and psychiatric morbidities. Dextro-transposition of the great arteries (d-TGA) is one of the most extensively studied cyanotic congenital heart defect (CHD) with regard to neurodevelopmental outcomes. Landmark studies have described a common neurodevelopmental and behavioral phenotype associated with d-TGA. Children with d-TGA display impairments in key neurocognitive areas, including visual-spatial and fine motor abilities, executive functioning, processing speed, and social cognition. As they grow older, they may face additional challenges with a worsening of deficits in higher order cognitive skills, problems in psychosocial adjustment and a higher-than-expected rate of psychiatric disorders, such as attention-deficit hyperactivity disorder, depression, and anxiety. The aim of this review is to summarize the available recent data on neuropsychological and psychiatric outcomes in individuals with d-TGA after the arterial switch operation. We present findings within a life-span perspective, with a particular emphasis on the emerging literature on adolescent and young adult outcomes. Finally, we propose avenues for future research in the CHD adult neuropsychology field. Among these avenues, we explore the potential mechanisms by which pediatric neurodevelopmental impairments may have lifelong adverse effects as well as alternative interventions that could optimize outcomes.

Anxiety, emotional processing and depression in people with multiple sclerosis.

BACKGROUND: Despite the high comorbidity of anxiety and depression in people with multiple sclerosis (MS), little is known about their inter-relationships. Both involve emotional perturbations and the way in which emotions are processed is likely central to both. The aim of the current study was to explore relationships between the domains of mood, emotional processing and coping and to analyse how anxiety affects coping, emotional processing, emotional balance and depression in people with MS. METHODS: A cross-sectional questionnaire study involving 189 people with MS with a confirmed diagnosis of MS recruited from three French hospitals. Study participants completed a battery of questionnaires encompassing the following domains: i. anxiety and depression (Hospital Anxiety and Depression Scale (HADS)); ii. emotional processing (Emotional Processing Scale (EPS-25)); iii. positive and negative emotions (Positive and Negative Emotionality Scale (EPN-31)); iv. alexithymia (Bermond-Vorst Alexithymia Questionnaire) and v. coping (Coping with Health Injuries and Problems-Neuro (CHIP-Neuro) questionnaire. Relationships between these domains were explored using path analysis. RESULTS: Anxiety was a strong predictor of depression, in both a direct and indirect way, and our model explained 48% of the variance of depression. Gender and functional status (measured by the Expanded Disability Status Scale) played a modest role. Non-depressed people with MS reported high levels of negative emotions and low levels of positive emotions. Anxiety also had an indirect impact on depression via one of the subscales of the Emotional Processing Scale ("Unregulated Emotion") and via negative emotions (EPN-31). CONCLUSIONS: This research confirms that anxiety is a vulnerability factor for depression via both direct and indirect pathways. Anxiety symptoms should therefore be assessed systematically and treated in order to lessen the likelihood of depression symptoms.

Early Detection of Poor Outcome after Mild Traumatic Brain Injury: Predictive Factors Using a Multidimensional Approach a Pilot Study.

Mild traumatic brain injury (MTBI) is a common condition within the general population, usually with good clinical outcome. However, in 10-25% of cases, a post-concussive syndrome (PCS) occurs. Identifying early prognostic factors for the development of PCS can ensure widespread clinical and economic benefits. The aim of this study was to demonstrate the potential value of a comprehensive neuropsychological evaluation to identify early prognostic factors following MTBI. We performed a multi-center open, prospective, longitudinal study that included 72 MTBI patients and 42 healthy volunteers matched for age, gender, and socioeconomic status. MTBI patients were evaluated 8-21 days after injury, and 6 months thereafter, with a full neurological and psychological examination and brain MRI. At 6 months follow-up, MTBI patients were categorized into two subgroups according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) as having either favorable or unfavorable evolution (UE), corresponding to the presence of major or mild neurocognitive disorder due to traumatic brain injury. Univariate and multivariate logistical regression analysis demonstrated the importance of patient complaints, quality of life, and cognition in the outcome of MTBI patients, but only 6/23 UE patients were detected early via the multivariate logistic regression model. Using several variables from each of these three categories of variables, we built a model that assigns a score to each patient presuming the possibility of UE. Statistical analyses showed this last model to be reliable and sensitive, allowing early identification of patients at risk of developing PCS with 95.7% sensitivity and 77.6% specificity.

Rehabilitation following cerebral anoxia: An assessment of 27 patients.

OBJECTIVES: (1) To evaluate cognitive and emotional impairments, disability and quality-of-life for adults with cerebral anoxia institutionalized in residential care facilities. (2) To evaluate the efficacy of medication, psychotherapy, support group and therapeutic activities. METHODS: Twenty-seven persons with cerebral anoxia were recruited, on average 8 years post-injury. Only 20 went through the whole study. Over three consecutive 2-month periods, they were assessed four times to evaluate: baseline observations (T1-T2), adjustment of their medication (T2-T3); and the effect of psychotherapy, support group and therapeutic activities such as physical and artistic or cultural activities usually proposed in the facilities involved (T3-T4). Examined variables at all time points were cognitive status, anxiety and depression, anosognosia, alexithymia, disability and quality-of-life. RESULTS: All participants exhibited cognitive and emotional impairments comparable to those reported in the literature. Statistical analyses revealed good baseline stability of their condition and no significant effects of changes in medication (between T2 and T3). Conversely, following implementation of psychotherapy, support group and therapeutic activities (between T3 and T4), quality-of-life and social participation were significantly improved. CONCLUSION: Social participation and quality-of-life for persons instutionalized several years after cerebral anoxia were improved by psychotherapeutic and therapeutic activities.

Prevalence and correlates of apathy in myotonic dystrophy type 1.

BACKGROUND: Apathy in DM1 has long been acknowledged in clinical practice. However, a major drawback is that the concept has been only sparsely explored in previous specific studies. This study aimed to determine the prevalence of apathy in myotonic dystrophy (DM1), to compare it with facioscapulohumeral dystrophy (FSHD) patients and normal healthy controls, and explore its relationship to psychopathological features and cognitive function. METHODS: Levels of apathy in 38 DM1 patients with adult phenotypes were compared with 19 patients with FSHD and 20 matched controls. Patient participants were consecutively recruited, regarding their interdisciplinary annual evaluation at the neuromuscular pathology reference center (Institute of Myology, Paris, France), within an 18-month period. Additional measurements included motor disability, fatigue, depression, anxiety, and cognitive abilities. Inter-group comparisons were performed using non-parametric Kruskal-Wallis tests and Mann-Whitney U Tests. Intra-group comparisons were carried out with the Wilcoxon Signed rank and Friedman tests. Also, Spearman's correlations were used to assess the strength of linear relationships between pairs of variables. The significance level was set at 0.05. RESULTS: Global score of apathy was significantly higher in DM1 patients than in FSHD patients (p < 0.01) and in controls (p < 0.001). Sixteen of 38 DM1 patients (39.5 %) met the criterion for apathy, contrasting with only 4 of the 19 (21.1 %) FSHD patients. No control subject was apathetic. Moreover, apathy in DM1 patients was negatively correlated to MMSE (r = -.46, p < .05) and Stroop Word (r = -.55, p < .01) scores, but not with age, educational level, disease duration, CTG repeats, motor functional disability, fatigue, depression, and anxiety. CONCLUSIONS: Apathy is a frequent symptom in DM1 (almost 40 %). It is more prevalent than in a similarly disabled group of patients with FSHD and in controls. Results also show that apathy in DM1 is independent of the psychopathological domain, fatigue, age, and motor disability, but associated to general cognitive status. These results altogether could suggest a central cause for apathy in DM1 rather than an adjustment process to cope with the progressive and debilitating nature of the disease. Data emphasize the importance to evaluate this symptom in routine clinical management of DM1 patients.

Screening for cognitive and affective dysfunction in patients suspected of mild cognitive impairment.

OBJECTIVE: Disturbances of affect expression and perception, as well as accuracy of predicting memory difficulties, have been reported in various brain dysfunctional groups. Screening tests of higher cerebral functions seldom sample these dimensions. The goal of this study was to determine if patients with mild cognitive impairment (MCI) of the amnestic type would demonstrate impairments in these domains, as well as show expected memory deficits. METHODS: Thirty-nine French-speaking patients with a clinical diagnosis of MCI were compared with 39 age- and education-matched normal functioning individuals on the French translation of the Barrow Neurological Institute Screen for Higher Cerebral Functions (BNIS). Patients and controls also made subjective ratings regarding their cognitive and affective functioning in everyday life. RESULTS: Patients with MCI performed significantly worse than controls on the BNIS subtests sampling memory, orientation, affect expression and perception, and accurate prediction of memory performance. They did not differ on other subtests of the BNIS, as predicted. Poor self-awareness (i.e., inaccurate prediction of the number of words one could recall after distraction) correlated with self-reported deficits in several areas of cognitive and affective functioning. CONCLUSION: This sample of MCI patients demonstrated disturbances not only in memory but also in self-awareness and affect expression and perception on the BNIS. These dimensions should be included in the neuropsychological assessment of patients suspected of MCI.

Performance of a French sample on the French translation of the BNI screen for higher cerebral functions.

OBJECTIVE: To obtain normative data using a French translation of the BNI Screen for Higher Cerebral Functions (BNIS) administered to French-speaking individuals. METHODS: Recruitment and administration of the BNIS to a convenience sample of 167 French-speaking individuals between the ages of 15-84 years. RESULTS: Mean BNIS total score for a French sample was within 1 point of what was observed in the original standardization study using 200 English-speaking controls. Age and education correlated significantly with BNIS scores in a manner reported by other studies. CONCLUSION: The French translation of the BNIS appears to be a reliable method of assessing higher cerebral functioning in French-speaking individuals.

Specific and evolving resting-state network alterations in post-concussion syndrome following mild traumatic brain injury.

Post-concussion syndrome has been related to axonal damage in patients with mild traumatic brain injury, but little is known about the consequences of injury on brain networks. In the present study, our aim was to characterize changes in functional brain networks following mild traumatic brain injury in patients with post-concussion syndrome using resting-state functional magnetic resonance imaging data. We investigated 17 injured patients with persistent post-concussion syndrome (under the DSM-IV criteria) at 6 months post-injury compared with 38 mild traumatic brain injury patients with no post-concussion syndrome and 34 healthy controls. All patients underwent magnetic resonance imaging examinations at the subacute (1-3 weeks) and late (6 months) phases after injury. Group-wise differences in functional brain networks were analyzed using graph theory measures. Patterns of long-range functional networks alterations were found in all mild traumatic brain injury patients. Mild traumatic brain injury patients with post-concussion syndrome had greater alterations than patients without post-concussion syndrome. In patients with post-concussion syndrome, changes specifically affected temporal and thalamic regions predominantly at the subacute stage and frontal regions at the late phase. Our results suggest that the post-concussion syndrome is associated with specific abnormalities in functional brain network that may contribute to explain deficits typically observed in PCS patients.

Correction: Specific and Evolving Resting-State Network Alterations in Post-Concussion Syndrome Following Mild Traumatic Brain Injury.

[This corrects the article DOI: 10.1371/journal.pone.0065470.].

Structural integrity and postconcussion syndrome in mild traumatic brain injury patients.

The presence of a postconcussion syndrome (PCS) induces substantial socio-professional troubles in mild traumatic brain injury (mTBI) patients. Although the exact origin of these disorders is not known, they may be the consequence of diffuse axonal injury (DAI) impacting structural integrity. In the present study, we compared structural integrity at the subacute and late stages after mTBI and in case of PCS, using diffusion-weighted imaging (DWI). Fifty-three mTBI patients were investigated and compared with 40 healthy controls. All patients underwent a DWI examination at the subacute (8-21 days) and late (6 months) phases after injury. MTBI patients with PCS were detected at the subacute phase using the ICD-10 classification. Groupwise differences in structural integrity were investigated using Tract-Based Spatial Statistics (TBSS). A loss of structural integrity was found in mTBI patients at the subacute phase but partially resolved over time. Moreover, we observed that mTBI patients with PCS had greater and wider structural impairment than patients without PCS. These damages persisted over time for PCS patients, while mTBI patients without PCS partly recovered. In conclusion, our results strengthen the relationship between structural integrity and PCS.

Social cognition impairments in relapsing-remitting multiple sclerosis.

Theory of Mind (ToM) is the ability to attribute independent mental states to self and others to explain and predict behavior. Impairment of ToM is well established in developmental pathologies. In neurological populations, investigation of ToM is still rare but data suggest that ToM impairment could contribute to behavioral and social disturbances. In addition to neurological signs, multiple sclerosis (MS) presents with disorders of cognition and behavior directly related to brain damage. The aim of this study was to assess ToM abilities and recognition of facial emotional expression in adults with MS. We compared 64 patients with relapsing MS and 30 matched healthy controls on three levels of ToM tasks, a facial emotion recognition task, and a neuropsychological assessment. MS patients performed significantly worse than controls in emotion recognition and all ToM tasks (p < .02). These deficits were not correlated with demographic variables or neuropsychological test performance. These findings underscore the importance of assessing ToM and facial recognition in MS, as dysfunction in these areas may impact upon social interaction and, thus, impair quality of life for both patients with MS and their families.

Diffusion tensor imaging and white matter lesions at the subacute stage in mild traumatic brain injury with persistent neurobehavioral impairment.

Mild traumatic brain injury (mTBI) can induce long-term behavioral and cognitive disorders. Although the exact origin of these mTBI-related disorders is not known, they may be the consequence of diffuse axonal injury (DAI). Here, we investigated whether MRI at the subacute stage can detect lesions that are associated with poor functional outcome in mTBI by using anatomical images (T(1) ) and diffusion tensor imaging (DTI). Twenty-three patients with mTBI were investigated and compared with 23 healthy volunteers. All patients underwent an MRI investigation and clinical tests between 7 and 28 days (D15) and between 3 and 4 months (M3) after injury. Patients were divided in two groups of poor outcome (PO) and good outcome (GO), based on their complaints at M3. Groupwise differences in gray matter partial volume between PO patients, GO patients and controls were analyzed using Voxel-Based Morphometry (VBM) from T(1) data at D15. Differences in microstructural architecture were investigated using Tract-Based Spatial Statistics (TBSS) and the diffusion images obtained from DTI data at D15. Permutation-based non-parametric testing was used to assess cluster significance at p < 0.05, corrected for multiple comparisons. Twelve GO patients and 11 PO patients were identified on the basis of their complaints. In PO patients, gray matter partial volume was significantly lower in several cortical and subcortical regions compared with controls, but did not differ from that of GO patients. No difference in diffusion variables was found between GO and controls. PO patients showed significantly higher mean diffusivity values than both controls and GO patients in the corpus callosum, the right anterior thalamic radiations and the superior longitudinal fasciculus, the inferior longitudinal fasciculus and the fronto-occipital fasciculus bilaterally. In conclusion, PO patients differed from GO patients by the presence of diffusion changes in long association white matter fiber tracts but not by gray matter partial volume. These results suggest that DTI at the subacute stage may be a predictive marker of poor outcome in mTBI.

Community integration after severe traumatic brain injury in adults.

PURPOSE OF REVIEW: Despite being the main cause of death and disability in young adults, traumatic brain injury (TBI) is a rather neglected epidemic. Community integration of persons with TBI was, until recently, insufficiently informed by clinical research. RECENT FINDINGS: To bridge the gap between rehabilitation and community re-entry, the first task is to assess the person, using TBI-specific outcome measures. The second task is to provide re-entry programs, the effectiveness of which is assessed by those measures, using well designed studies. There are very few such studies. However, there are some effective comprehensive programs and others which are specifically targeted dealing mainly with return to work, behavior, and family issues. The complex psychological and environmental components of the disability require individualized and often long-term care. SUMMARY: For persons with severe TBI trying to achieve the best possible community integration a new semiology is required, not just limited to medical care, but also involving social and psychological care that is tailored to the needs of each individual and family, living within his/her environment. Currently, only a minority benefit from well validated programs.

Multi-center evaluation of the hepatitis B surface antigen (HBsAg) assay and HbsAg confirmatory assay for the family of Access immunoassay systems.

BACKGROUND: Accurate detection of Hepatitis B Surface Antigen (HBsAg) is an important aid in the diagnosis of patients infected with the hepatitis B virus (HBV). A multi-center study was conducted to characterize the performance of the HBsAg assay on the family of Access immunoassay systems from Beckman Coulter. METHODS: The Access HBsAg assay was characterized in a multi-center study and compared to the Abbott AxSYM* and PRISM* HBsAg assays. The bioMérieux VIDAS* assay was used to resolve discrepant results. Reproducibility studies (intra-assay, inter-assay and inter-lot) were performed with pooled serum samples (negative sample, close to cut off, low, medium and high positive samples). Analytical sensitivity, subtype and genotype detection were studied with various commercial panels (SFTS panel, WHO 80/549, WHO 00/588, Teragenix HBV Genotype panel). A panel of recombinant HBsAg mutant proteins was tested to investigate reactivity towards genetic mutations. Clinical sensitivity was verified with seroconversion panels and samples from subjects with known HBV infection. Analytical specificity was studied with samples from patients with potential cross-reactive infections. Clinical specificity was validated among blood donors and a hospitalized population. RESULTS: The imprecision was < 10%. Analytical sensitivity was < or = 0.1 ng/mL (SFTS panel), 0.020 PEI Units/mL (ad panel), 0.024 PEI Units/mL (ay panel), 0.092 IU/mL with WHO 80/549 and 0.056 IU/mL with WHO 00/588. All genotype samples and HBsAg mutants were reactive with the Access HBsAg assay. Seroconversion panels tested showed no significant difference with the reference method. Sensitivity for subjects with known HBV infection was 100%. No interference with potentially cross-reactive infections was observed after confirmatory testing. Specificity was 99.96% (100% after confirmatory testing) in a blood donor population and 99.5% (100% after confirmatory testing) in a hospitalized population. Excellent separation of positive and negative populations was observed. CONCLUSIONS: The Access HBsAg and HBsAg Confirmatory assays meet all clinical and analytical performance requirements of assays for the detection of HBsAg.

Simultaneous detection of hepatitis C virus (HCV) core antigen and anti-HCV antibodies improves the early detection of HCV infection.

To evaluate whether a new enzyme immunoassay developed for the simultaneous detection of hepatitis C virus (HCV) core antigen (Ag) and anti-HCV antibodies (anti-HCV Ab) (Monolisa HCV Ag/Ab ULTRA; Bio-Rad) could improve the early detection of HCV infection, we compared its sensitivity to that of anti-HCV, HCV core Ag, and HCV RNA assays. The populations studied included 12 blood donor samples positive for HCV RNA and HCV core Ag but negative for anti-HCV antibodies and 23 hemodialysis patients who developed anti-HCV Ab (seroconversion) during the follow-up. From these 23 individuals, 83 samples sequentially collected prior to seroconversion and 108 samples collected after seroconversion were tested. Six of 12 blood donations were positive by the HCV Ag/Ab assay. In the hemodialysis cohort, the 24 HCV RNA-negative samples were negative by the HCV Ag/Ab assay and 23 of the 59 HCV RNA-positive samples (39%) were positive. The HCV Ag/Ab assay detected HCV infection on average 21.6 days before the most sensitive antibody assay. The HCV Ag/Ab assay did not detect HCV infection as early as the HCV RNA assay (mean delay, 30.3 days) or HCV Ag assay (mean delays, 27.9, and 16.3 days by the HCV core Ag quantification assay and the HCV Ag blood screening assay, respectively). This new assay provides a notable improvement for the early detection of HCV infection during the so-called window period compared with anti-HCV Ab assays and could be a useful alternative to HCV RNA detection or HCV core Ag assays for diagnosis or blood screening when nucleic acid technologies or HCV core Ag detection are not implemented.