Viral load and genotypes of noroviruses in symptomatic and asymptomatic children in Southeastern Brazil

BackgroundNoroviruses (NoVs) are a major etiological agent of sporadic acute gastroenteritis worldwide.ObjectivesTo detect, quantify and characterize genogroups and genotypes of NoVs in children with and without gastrointestinal symptoms.Study designNoVs were investigated by RT-PCR in a total of 319 fecal specimens from children up to three years old with (n = 229) and without (n = 90) acute diarrhea, between February 2003 and June 2004 in the emergency room in Vitória, Southeastern Brazil. NoVs were quantified by real-time PCR and genotyped.ResultsNoVs were detected in 17% (40/229) and 13% (12/90) of symptomatic and asymptomatic children, respectively. Six NoV-rotavirus A mixed infections were observed. Fifty-one strains were characterized as NoV GII and one as GI. Twenty strains were characterized as GII/4 (9/13), GII/3 (1/13), GII/6 (2/13) and GII/14 (1/13) in symptomatic and GII/3 (6/7) and GII/8 (1/7) in asymptomatic children. The median RNA viral loads were 8.39 and 7.15 log₁₀ copies/g of fecal specimens for symptomatic and asymptomatic children, respectively (p = 0.011). NoV load was lower when it was present in a mixed infection with rotavirus A (p = 0.0005).ConclusionsThis study demonstrates a diversity of NoV strains circulating in this geographic area, and reports GII/8 and GII/14 in the American Continent for the first time. In addition, it confirms GII/4 as the most prevalent genotype in symptomatic children and identified GII/3 in an important frequency, especially in asymptomatic children. Furthermore, preliminary results show that symptomatic patients present a viral load that is significantly greater than asymptomatic children (p = 0.011).     

Multiple enteropathogenic viruses in a gastroenteritis outbreak in a military exercise of the Portuguese Army

BackgroundGastroenteritis is one of the most common infectious diseases in the military populations and can diminish operational effectiveness and impede force readiness.ObjectivesThe present study investigates the cause and the source of an acute gastroenteritis outbreak that occurred during a military exercise of the Portuguese Army, in February 2013.Study DesignA retrospective investigation was performed and stool samples, food items and water were screened for common foodborne bacteria and viruses, namely Norovirus GI, Norovirus GII, Astrovirus, Rotavirus, Adenovirus and Sapovirus.ResultsFrom the total of 160 soldiers that participated in the military exercise 20 developed gastroenteritis (attack rate of 12.5%). Symptoms were predominantly vomiting (n = 17, 85%) and diarrhoea (n = 9, 45%). The first cases occurred 24–48 h after drinking water from the creek, the plausible origin of the outbreak. The epidemic peak was registered 2 days after and the last cases 6 days after, upon returning to base. No pathogenic bacteria were found in stools however virological analysis revealed the presence of multiple enteropathogenic viruses, namely Norovirus GI (GI.3), Norovirus GII (GII.4 New Orleans 2009), Astrovirus and Sapovirus, as single or co-infections. Food and water samples were not tested for the presence of viruses due to exhaustion of samples on bacteriological analysis.ConclusionsTo the best of our knowledge this is the first report of a viral gastroenteritis outbreak among military personnel in the Portuguese Army.     

Genetic characterisation of Norovirus strains in outpatient children from rural communities of Vhembe district/South Africa, 2014–2015

BackgroundNorovirus (NoV) is now the most common cause of both outbreaks and sporadic non-bacterial gastroenteritis worldwide. However, data supporting the role of NoV in diarrheal disease are limited in the African continent.ObjectivesThis study investigates the distribution of NoV genotypes circulating in outpatient children from rural communities of Vhembe district/South Africa.Study designStool specimens were collected from children under five years of age with diarrhea, and controls without diarrhea, between July 2014 and April 2015. NoV-positive samples, detected previously by Realtime PCR, were analysed using conventional RT-PCR targeting the partial capsid and polymerase genes. Nucleotide sequencing methods were performed to genotype the strains.ResultsThe sequence analyses demonstrated multiple NoV genotypes including GI.4 (13.8%), GI.5 (6.9%), GII.14 (6.9%), GII.4 (31%), GII.6 (3.4%), GII.P15 (3.4%), GII.P21 (3.4%) and GII.Pe (31%). The most prevalent NoV genotypes were GII.4 Sydney 2012 variants (n = 7) among the capsid genotypes, GII.Pe (n = 9) among the polymerase genotypes and GII.Pe/GII.4 Sydney 2012 (n = 8) putative recombinants among the RdRp/Capsid genotypes. Two unassigned GII.4 variants were found.ConclusionsThe findings highlighted NoV genetic diversity and revealed continuous pandemic spread and predominance of GII.Pe/GII.4 Sydney 2012, indicative of increased NoV activity. An unusual RdRp genotype GII.P15 and two unassigned GII.4 variants were also identified from rural settings of the Vhembe district/South Africa. NoV surveillance is warranted to help to inform investigations into NoV evolution and disease burden, and to support on-going vaccine development programmes.     

Norovirus prevalence and estimated viral load in symptomatic and asymptomatic children from rural communities of Vhembe district,South Africa

BackgroundHuman Norovirus (NoV) is recognized as a major etiological agent of sporadic acute gastroenteritis worldwide.ObjectivesThis study describes the clinical features associated with Human NoV occurrence in children and determines the prevalence and estimated viral burden of NoV in symptomatic and asymptomatic children in rural South Africa.Study designBetween July 2014 and April 2015, outpatient children under 5 years of age from rural communities of Vhembe district, South Africa, were enrolled for the study. A total of 303 stool specimens were collected from those with diarrhea (n = 253) and without (n = 50) diarrhea. NoVs were identified using real-time one-step RT-PCR.ResultsOne hundred and four (41.1%) NoVs were detected (62[59.6%] GII, 16[15.4%] GI, and 26[25%] mixed GI/GII) in cases and 18 (36%) including 9(50%) GII, 2(11.1%) GI and 7(38.9%) mixed GI/GII in controls. NoV detection rates in symptomatic and asymptomatic children (OR = 1.24; 95% CI 0.66⿿2.33) were not significantly different. Comparison of the median C_T values for NoV in symptomatic and asymptomatic children revealed significant statistical difference of estimated GII viral load from both groups, with a much higher viral burden in symptomatic children.ConclusionsThough not proven predictive of diarrhea disease in this study, the high detection rate of NoV reflects the substantial exposure of children from rural communities to enteric pathogens possibly due to poor sanitation and hygiene practices. The results suggest that the difference between asymptomatic and symptomatic children with NoV may be at the level of the viral load of NoV genogroups involved.     

Norovirus GII.4 variant 2006b caused epidemics of acute gastroenteritis in Australia during 2007 and 2008

BackgroundOver the last decade, four epidemics of norovirus-associated gastroenteritis have been reported in Australia. These epidemics were characterized by numerous outbreaks in institutional settings such as hospitals and nursing homes, as well as increases in requests for NoV testing in diagnostic centers. During 2007 and 2008, widespread outbreaks of acute gastroenteritis were once again seen across Australia, peaking during the winter months.ObjectivesThe primary objective of this study was to characterize two winter epidemics of NoV-associated gastroenteritis in 2007 and 2008 in Australia. Following this, we aimed to determine if these epidemics were caused by a new GII.4 variant or a previously circulating NoV strain.Study designNoV-positive fecal samples (n = 219) were collected over a 2-year period, December 2006 to December 2008, from cases of acute gastroenteritis in Australia. NoV RNA was amplified from these samples using a nested RT-PCR approach targeting the 5′ end of the capsid gene, termed region C. Further, characterization was performed by sequence analysis of the RdRp and capsid genes and recombination was identified using SimPlot.ResultsFrom 2004 to 2008, peaks in the numbers of NoV-positive EIA tests from the Prince of Wales Hospital Laboratory correlated with the overall number of gastroenteritis outbreaks reported to NSW Health, thereby supporting recent studies showing that NoV is the major cause of outbreak gastroenteritis. The predominant NoV GII variant identified during the 2007–2008 period was the GII.4 pandemic variant, 2006b (71.51%, 128/179), which replaced the 2006a variant identified in the previous Australian epidemic of 2006. Four novel GII variants were also identified including the three GII.4 variants: NoV 2008, NoV Osaka 2007 and NoV Cairo 2007, and one novel recombinant NoV designated GII.e/GII.12.ConclusionThe increase in acute gastroenteritis outbreaks in 2007 and 2008 were associated with the spread of the NoV GII.4 variant 2006b.     

Norovirus in feces and nasopharyngeal swab of children with and without acute gastroenteritis symptoms: First report of GI.5 in Brazil and GI.3 in nasopharyngeal swab

BackgroundNoroviruses (NoVs) are an important cause of acute gastroenteritis (AGE), worldwide.ObjectivesTo evaluate the frequency, viral load and molecular profile of NoV in fecal and nasopharyngeal swab samples from hospitalized children, and to determine children’s secretor status.Study designFrom May 2014 to May 2015, 219 children were included in the study, 96 with gastroenteric symptoms and 123 without gastroenteric symptoms. All fecal and nasopharyngeal swab samples were screened by TaqMan RT-qPCR duplex (GI/GII NoV) and quality samples were characterized by genomic sequencing.ResultsNorovirus positivity rate in feces was 15.4% in asymptomatic and 18.8% in the symptomatic group. The median viral loads in feces were 2.69 × 10⁸ GC/g and 4.32 × 10⁷ GC/g from children with or without AGE symptoms, respectively. In nasopharyngeal swab samples, the NoV positivity was 11.4% in symptomatic children, with a median viral load of 2.20 × 10⁷ GC/mL and 6.5% in asymptomatic children, with an average viral load of 1.73 × 10⁶ GC/mL. In only two cases NoV was detected in both samples. A considerable genomic variability was observed in feces, with six genotypes being detected, as follows: GII.4, GII.6, GI.3 and GII.3, GI.2 and GI.5. Two GI.3 was detected in nasopharyngeal swab.ConclusionsOur data reveal considerable NoV frequencies in both nasopharyngeal and fecal samples from symptomatic and asymptomatic children. Higher viral loads were detected in samples from AGE symptomatic children, when compared to asymptomatic children. High genomic variability was observed, with this being the first report of GI.5 NoV in Brazil and of GI.3 in nasopharyngeal swab samples.     

Detection of human rhinovirus C in fecal samples of children with gastroenteritis

BackgroundDespite recent discovery of the novel human rhinovirus species, HRV-C, little is known about the association of HRV-C in diseases other than respiratory tract infections.ObjectivesTo investigate the presence of HRV-C in fecal samples of children with gastroenteritis.Study design734 fecal samples from hospitalized children with gastroenteritis were subject to picornavirus detection by RT-PCR of the conserved 5′-NCR. Positive samples were subject to VP4 and 3D^pol gene analysis for species determination. The clinical and molecular epidemiology of HRV-C and other picornaviruses was analyzed.ResultsPicornaviruses were detected in 113 (15.4%) of 734 fecal samples from children with gastroenteritis by RT-PCR of 5′-NCR, with 58 containing potential HRVs and 55 containing other enteroviruses. PCR of the VP4 and 3D^pol regions was positive in 21 and 19 samples respectively (both regions positive in 8 samples). Sequencing analysis showed the presence of HRV-C in four samples, and diverse picornaviruses including HRV-A (n = 2), HEV-A (n = 2), HEV-B (n = 2), HEV-C (n = 21) and HPeV (n = 2) in other samples, with co-detection of HRV-C and HPeV in one sample. Of the four children with HRV-C detected in fecal samples, three presented with diarrhea in the absence of respiratory symptoms, while one also had acute bronchiolitis. The four HRV-C strains from fecal samples belonged to the existing clade of diverse HRV-C genotypes, indistinguishable from previous respiratory strains.ConclusionsHRV-C can be detected in fecal samples of children with gastroenteritis, in the absence of respiratory symptoms. This study also represented the first to detect HPeV in our population.     

Emergence of Norovirus GII.4 variants in acute gastroenteritis outbreaks in South Korea between 2006 and 2013

BackgroundNew emerging strains of noroviruses (NoVs) often increase acute gastroenteritis (AGE) outbreaks worldwide.ObjectiveWe analyzed the epidemiological features and genotypic patterns of NoVs in AGE outbreaks.Study designTo elucidate the public health impact of NoVs during AGE outbreaks in South Korea, a molecular and epidemiological investigation was performed with 318 AGE outbreaks reported from the Gyeonggi province of South Korea during the period from 2006 to 2013.ResultsNoVs were associated with 102 (32.1%) of the AGE outbreaks. Epidemiological data revealed that the majority of NoV outbreaks were in the student group (47.1%), and the majority of AGE patients were identified in schools (68.8%). NoV genogroup (G) II strains were associated with 94 (92.2%) of the NoV outbreaks, and GII.4 strains were predominantly associated with 57.6% (n = 49) of NoV GII outbreaks. Four GII.4 variants (2006b, 2007, 2009 and 2012 variants) emerged and showed different contributions to NoV outbreak activity. The 2006b variant was predominantly associated with NoV outbreaks during the early years of the study period, and was subsequently displaced by the New Orleans 2009 variant, and most recently by the Sydney 2012 variant. In addition, the GII.2, GII.14, and GII.17 strains have recently been often associated with NoV AGE outbreaks.ConclusionsThe emergence of new NoV GII.4 variants significantly affected the NoV outbreak activity in South Korea during the period from 2006 to 2013. The surveillance for new emerging strains affecting NoV outbreak activity should be intensified to develop an adequate policy to prevent further NoV outbreaks.     

Human papillomavirus is detectable in Barrett's esophagus and esophageal carcinoma but is unlikely to be of any etiologic significance

Barrett's esophagus (BE), a known precursor of esophageal adenocarcinoma has recently been associated with human papillomavirus (HPV). p16^INK4a expression is a recognized surrogate marker of HPV infection in the cervix.ObjectivesThis study has assessed the possible role of human papillomavirus (HPV) infection in BE and esophageal adenocarcinoma, in the North American population by screening esophageal tissues for HPV by a combination of assays.Study designFormalin-fixed, paraffin-embedded blocks from cases of Barrett's esophagus (n = 84), esophageal adenocarcinoma (n = 36) and normal gastro-esophageal junction (n = 29) were examined for HPV by PCR, chromogenic in situ hybridization, and p16^INK4a immunohistochemistry.ResultsHPV DNA was detected by PCR in 23 of 84 (27.4%) BE cases, 11 of 36 (31%) cases of adenocarcinoma and in 7 of 29 (24%) normal control cases (p = 0.82). p16^INK4a staining was positive in 10 (12%) cases of BE, 15 (42%) cases of adenocarcinoma and 6 (21%) cases of the control group. Positive p16^INK4a staining was not statistically different between the three groups whether positive or negative for HPV DNA (p = 0.91 and p = 0.91 respectively). Similarly, negative p16^INK4a staining did not show a difference between the three groups for whether positive or negative for HPV DNA (p = 0.50 and p = 0.28, respectively). HPV was not detected by CISH in the adenocarcinomas while in BE and control groups, CISH was non-contributory.ConclusionsThese data suggest that while HPV is detectable in a subset of esophageal lesions and tumors, the HPV detected is unlikely to be of etiologic significance or a factor accounting for the increase in BE and esophageal adenocarcinoma cases in the United States.     

A brief dyadic group based psychoeducation program improves relapse rates in recently remitted bipolar disorder: A pilot randomised controlled trial

BackgroundVarious adjunctive psychotherapies assist in decreasing relapse and improving outcomes for people with bipolar disorder (BD). Psychoeducation programs involving patient-only or caregiver-only groups have demonstrated some efficacy. We tested in recently remitted BD if a combined group based psychoeducation program involving patient–companion dyads decreased relapse.Method58 recently remitted BD out-patients were randomised to receive either treatment as usual (TAU, n = 31) or 12 × 90 minute psychoeducation sessions delivered weekly in a group program to the patient and companion (SIMSEP, n = 27). After 12 weeks SIMSEP patients reverted to TAU and all patients were followed until week 60 or relapse. The primary outcome measure was relapse requiring hospital or intensive community intervention.Results45 patients completed the study. 29 patients remained well at week 60 (SIMSEP n = 17, TAU n = 12), whilst 16 had relapsed (SIMSEP n = 3, TAU n = 13). The SIMSEP group were less likely to relapse (Fisher's exact test p = 0.013; OR = 0.16; 95% CI 0.04–0.70) and had an 11 week longer time to relapse compared to the TAU group (chi-square (1) = 8.48, p < 0.01). At study completion SIMSEP compared to TAU patients had lower Young Mania Rating Scale scores (Mann–Whitney U = 255, p < 0.01).LimitationsThe study was limited by a small sample size.ConclusionA brief group psychoeducation program with recently remitted BD patients and their companions resulted in a decreased relapse rate, longer time to relapse, decreased manic symptoms and improved medication adherence suggesting utility in the adjunctive psychotherapeutic treatment of BD.     

The impact of medical informatics on patient satisfaction: A USA-based literature review

PurposePatient satisfaction is increasingly recognized as an important component of quality. The expansion of health information technologies (HIT) might have an impact on patient satisfaction – either positively or negatively. We conducted a literature review to explore the impact of these technologies on patient satisfaction.MethodsThe database of PubMed was searched from inception through May 2010, using the MeSH terms “Medical Informatics” and “Patient Satisfaction”. We included all original interventional studies regardless of their study design that were published in English and were evaluating HIT impact on patient satisfaction. Studies were categorized by technology type according to the American Medical Informatics Association framework and by study design. The major outcome of interest was the HIT impact on patient satisfaction.ResultsOf 1293 citations reviewed, 56 studies met our inclusion criteria. Design of these studies included mostly randomized controlled trials (RCTs) (n = 20, 36%), cross-sectional surveys (n = 17, 30%), and a pre and post studies (n = 14, 25%). Overall, 54% (n = 30) of the studies demonstrated a positive effect of HIT on patient satisfaction, 34% (n = 19) failed to show any effect, 11% (n = 6) had inconclusive results, and 2% (n = 1) revealed a negative effect. Of the 20 RCTs, 40% (n = 8) showed a positive effect of HIT on patient satisfaction, 50% (n = 10) failed to show any effect, and 10% (2) had inconclusive results.ConclusionsAnalysis suggested that while there is some evidence that HIT improves patient satisfaction, studies in this literature review, and in particularly RCTs, were not consistent in their findings. Although HIT may be a promising tool to improve patient satisfaction, more well-designed research studies are needed in order to get a better understanding of this domain and accordingly find new opportunities to improve quality of care.     

Acute norovirus gastroenteritis in children in a highly rotavirus-vaccinated population in Northeast Brazil

BackgroundGastroenteritis is one of the most important causes of morbidity and mortality in children and an important etiological agent is norovirus.ObjectiveWe describe the occurrence and characteristics of norovirus diarrhoea in children from Sergipe, Northeast-Brazil, over two consecutive periods of three years following rotavirus vaccine introduction.Study designA cross sectional hospital-based survey conducted from October-2006 to September-2009 and from July-2011 to January-2013. Acute diarrhoea cases had a stool sample collected and tested for norovirus by RT-PCR and positive samples were sequenced.ResultsIn total 280 (19.6%) of 1432 samples were norovirus positive, including 204 (18.3%) of 1113 samples collected during the first period and 76 (23.9%) of 318 collected during the second period. The proportion of children with norovirus infection increased significantly through the second study period (χ² for trend = 6.7; p = 0.009), was more frequent in rotavirus vaccinated and in younger children (p < 0.001). Of 280 norovirus-positive specimens, 188 (67.1%) were sequenced. Of these, 12 were genogroup I and 176 genogroup II. The main genotype was GII.4 (149/188, 79.3%), followed by GII.2 (6, 3.2%) and GII.6 (5, 2.6%).ConclusionNorovirus annual detection rates increased over the study period. The detection of norovirus was higher among young children.     

Review with novel markers facilitates precise categorization of 41 cases of diagnostically challenging, “undifferentiated small round cell tumors”. A clinicopathologic,immunophenotypic and molecular analysis

BackgroundDespite extensive immunohistochemical (IHC) and molecular studies combined with morphologic findings, a group of round/ovoid cell tumors histologically similar to Ewing sarcomas (ES) but lacking EWSR1-rearrangements may remain unclassifiable.DesignWe retrospectively analyzed 41 Ewing-like tumors (formalin-fixed, paraffin-embedded) previously determined as negative or non-informative for EWSR1-rearrangements by FISH and/or RT-PCR. A new histopathology revision and additional IHC and molecular analyses were carried out in order to investigate whether additional IHC and/or molecular testing in combination with the morphological findings may help in reaching a definitive diagnosis.ResultsAlmost all the tumors (n = 40) involved soft tissue and/or bone and half the patients died of disease. In the archival cases all diagnoses were Ewing sarcoma (ES), Ewing-like sarcoma (ELS), myoepithelial tumor and undifferentiated sarcoma (US). In the new review all the tumors were re-classified as, ES (n = 16), Ewing-like tumor with EWSR1 rearrangement and amplification and possible EWSR1-NFATC2 gene fusion (n = 1), CIC-rearranged sarcomas or undifferentiated sarcoma, most consistent with CIC-rearranged sarcoma (n = 7), sarcoma with BCOR-alteration or undifferentiated sarcoma, consistent with BCOR-associated sarcoma (n = 3), neuroblastoma (n = 2), unclassifiable neoplasm with neuroblastic differentiation (n = 1), malignant rhabdoid tumor (n = 2), lymphoblastic lymphoma (n = 1), clear cell sarcoma of the gastrointestinal tract (n = 1), small cell carcinoma (n = 1), sclerosing rhabdomyosarcoma (n = 1), desmoplastic small round cell tumor (n = 1), malignant peripheral sheath nerve tumor (n = 1), poorly-differentiated synovial sarcoma (n = 1), Possible gastrointestinal stromal tumor/GIST with predominant round cells (n = 1) and possible SMARCA4-deficient-sarcoma (n = 1). NKX2.2, ETV4 and BCOR immunoreactivity was observed in all ES, CIC-rearranged sarcomas and sarcomas with BCOR alteration, respectively. CIC-rearrangement by FISH was observed in many of the CIC-rearranged sarcomas.ConclusionOur analysis of 41 Ewing-like tumors confirms that there may be a significant pathological and IHC overlap among Ewing-like tumors, with prognostic and therapeutic impacts. Additional IHC (NKX2.2, ETV4 and BCOR) and molecular studies including FUS, CIC or BCOR analysis may support the final diagnosis when FISH or RT-PCR fail to detect EWSR1-rearrangements. Any molecular findings should always be interpreted in relation to the specific clinical and pathological context.     

GENEDIA Multi Influenza Ag Rapid Test for detection and H1, H3, and H5 subtyping of influenza viruses

BackgroundRapid identification and subtype determination of influenza virus is important in managing infected patients. Rapid influenza diagnostic tests (RIDTs) are widely used in this manner, but most can only detect influenza A and B viruses without subtyping. A new RIDT, GENEDIA Multi Influenza Ag Rapid Test (GENEDIA), was developed for detection of influenza A and B viruses and also subtyping of influenza A to H1, H3, H5 which has not been possible with other RIDTs.ObjectivesAssess the performance of GENEDIA.Study designNasopharyngeal swabs were collected from 274 clinically suspected patients (influenza A/H1N1/2009 (n = 50), influenza A/H3 (n = 50), influenza B (n = 73) and influenza-negative (n = 101)) and analyzed with the real-time RT-PCR, GENEDIA, SD Bioline Influenza Ag, and Alere BinaxNow Influenza A&B Card. Also, 46 fecal specimens (H5N2 (n = 3), H5N3 (n = 3)) of spot-billed duck were analyzed with RT-PCR and GENEDIA.ResultsCompared to real-time RT-PCR, the sensitivities of GENEDIA, SD Bioline Influenza Ag, and Alere BinaxNow Influenza A&B Card were 73.0%, 57.0%, 58.0% for influenza A, respectively, and 68.5%, 65.8%, 57.5% for influenza B, respectively. Specifically, the sensitivity of GENEDIA was 70.0% for influenza A/H1N1/2009 and 76.0% for influenza A/H3. From the avian influenza samples, GENEDIA detected all six H5 subtype without any cross-reactions.ConclusionThe GENEDIA Multi Influenza Ag Rapid Test was sensitive in detecting influenza viruses compared with other commercial RIDTs and also useful for rapid subtype determination of influenza A.     

Performance of an antigen assay for diagnosing acute hepatitis E virus genotype 3 infection

BackgroundHepatitis E virus (HEV) is a major cause of hepatitis worldwide. Its diagnosis is based on the detection of anti-HEV IgM and/or HEV-RNA.ObjectiveTo evaluate the performance of the Wantaï HEV-antigen (Ag) ELISA^Plus assay for diagnosing acute HEV infections.Study designSpecificity was assessed using 100 blood samples containing no anti-HEV IgM, anti-HEV IgG, or HEV-RNA. Cross reactivity was assessed using samples positive for hepatitis C virus RNA (n = 10), Epstein-Barr virus DNA (n = 10) and cytomegalovirus DNA (n = 10). Serial dilutions of 4 HEV RNA positive samples were used to estimate the corresponding viremia detected with the Ag assay. Blood samples from 33 immunocompetent and 31 immunocompromised patients with an acute HEV genotype 3 infection, HEV-RNA positive, were tested to assess diagnostic sensitivity.ResultsThe HEV-Ag assay was 100% specific, with no cross-reactivity. The lower viremias detected ranged from 10³ copies/ml to 10⁵ copies/ml (800–80,000 UI/ml). Diagnostic sensitivity for an acute HEV infection was 91%, with no significant difference between immunocompetent (88%) and immunocompromised (94%) patients. The HEV-Ag assay was more frequently positive in immunocompromised patients at the acute phase (94%) than was the anti-HEV IgM test (71%; p = 0.04). The HEV-Ag assay ratio was correlated with HEV-RNA viral load (ρ = 0.54; p < 0.0001).ConclusionThe HEV-Ag assay performed well and could be suitable for laboratories with no molecular diagnosic facilities.