Autochthonous hepatitis E in Southwest England: a comparison with hepatitis A

The incidence of hepatitis A is falling. In contrast, autochthonous hepatitis E is an emerging infection in developed countries. The objective of this study was to compare both laboratory-confirmed cases of hepatitis A and autochthonous hepatitis E over a 2-year period in Cornwall and Devon and anti-hepatitis A virus (HAV) IgG and anti-hepatitis E virus (HEV) IgG seroprevalence in blood donors. The databases of microbiology laboratories in Cornwall and Devon were searched for the number of diagnostic HEV and HAV assays performed during 2005-2006 and the number of confirmed cases of acute hepatitis A and hepatitis E detected. Patients were followed up until recovery or death. Sera from 500 blood donors from the regional centre were tested for HEV and HAV IgG. In total, 28 cases of autochthonous hepatitis E were identified from 838 assays, and 20 cases of hepatitis A were identified from 4503 assays. Compared to hepatitis A cases, patients with hepatitis E were older (mean age 61 vs. 45 years, P = 0.003), less likely to present in winter (P = 0.028) and had more complications (five vs. one). The IgG seroprevalence rates in blood donors were 45% for HAV and 16% for HEV. There was no relationship between HAV and HEV IgG seropositivity. Autochthonous hepatitis E may be more common than hepatitis A, affects older patients, is less likely to occur in winter and may be associated with more complications. Patients with acute hepatitis, whatever their age or travel history, should be tested for HEV.     

Foetomaternal Outcomes of Hepatitis E Infection Outbreak in North India

Hepatitis E infection (HEV) in pregnant females, especially in the third trimester is associated with poor foetomaternal outcomes. However, the mechanisms of severe liver injury remain obscure. In a recent HEV outbreak in North India, six pregnant females were detected to be positive for HEV infection with concomitant hepatitis A infection in three pregnant females. None of the pregnant females were positive for hepatitis B or hepatitis C infection. The mortality was 50% in pregnant females. In an outbreak, besides, testing for hepatitis markers and understanding the pathogenesis of HEV infection in pregnancy, improving basic hygienic standards is of utmost importance.     

IgM and IgG antibodies to hepatitis E virus (HEV) detected by an enzyme immunoassay based on an HEV-specific artificial recombinant mosaic protein

To develop an enzyme immunoassay (EIA) for IgM antibody to hepatitis E virus (HEV) (IgM anti-HEV) and IgG antibody to HEV (IgG anti-HEV), a synthetic gene encoding several liner immuno-dominant antigenic epitopes from HEV structural proteins was assembled as a chimeric recombinant mosaic protein (Mpr) with glutathione S-transferase and used as an immunodiagnostic target. In addition, a neutralization confirmation test was developed using individual synthetic peptides. Among 614 patients with acute hepatitis from 10 geographically distinct outbreaks, IgG anti-HEV was found in 546 (88.9%), with a range of 77–100% depending on the outbreak. Of 130 patients tested for IgM anti-HEV, 126 (96.9%) were positive. Among patients tested within 4 months of onset of jaundice, 37/37 (100%) were IgG anti-HEV positive. For patients from whom sera were collected 1–16 days after onset of jaundice, the geometric mean IgG titer (GMT) was 1:47,000; the GMT increased to 1:70,710 30–40 days after onset of jaundice and decreased to 1:1,778 3–4 months after the onset of jaundice. For patients tested 6–8 months after onset of jaundice, 11/12 (92%) were IgG anti-HEV positive, and the GMT was 1:2,908. IgM anti-HEV was detected in 43/43 (100%) sera collected 1–40 days after onset of jaundice, and the GMT for IgM anti-HEV was 1:10,000 at that time. For sera collected 3–4 and 6–12 months after onset of jaundice, 7/14 (50%) and 5/12 (40%) respectively, were IgM anti-HEV positive. In conclusion, an artificial mosaic protein composed of linear antigenic epitopes from open reading frame 2 (ORF2) and ORF3 of HEV has been successfully applied to the development of a sensitive and specific EIA for the detection of IgG and IgM anti-HEV activity. These assays were used for the verification of HEV infection in outbreak settings and for the diagnosis of HEV infection in sporadic cases. © 1996 Wiley-Liss, Inc.     

Prolonged jaundice attributed to super infection of hepatitis E virus in a case of resolving leptospirosis

India is endemic for both Leptospira and hepatitis E virus (HEV). The clinical presentations of these diseases have overlapping features. We report a case of superinfection of HEV in a patient with resolving leptospirosis with underlying Hodgkin lymphoma. The diagnosis of HEV in our case was established by HEV-RNA PCR as our patient was immunosuppressed. The present study highlights the need for molecular diagnosis in the case of HEV infection with strong clinical suspicion and negative serological results.     

Hepatitis E virus seroprevalence in acute viral hepatitis in a developed country confirmed by a supplemental assay

Hepatitis E virus (HEV) infection is prevalent among cases of acute viral hepatitis in young adults in developing countries. HEV infection is not restricted to endemic areas, but would appear to be worldwide in distribution. In order to document the incidence of HEV infection in acute hepatitis cases in a developed country, IgG and IgM anti-HEV antibodies and HEV RNA were tested in 101 Caucasian patients with acute viral hepatitis; 92 of these cases had markers of acute viral hepatitis other than HEV. Forty-seven (46.5%) cases had IgG anti-HEV; IgM anti-HEV and HEV viremia were not detected. As the incidence of anti-HEV was higher than would be expected, the possibility of the occurrence of false positive results was subsequently investigated. Supplemental antibody testing, using a broadly reactive epitope region, reduced the frequency of anti-HEV to 17%. Therefore, supplemental antibody testing confirms the hepatitis E virus seroprevalence in a developed country. Since IgM anti-HEV and HEV viremia were not detected, persons with IgG anti-HEV may be “subclinical HEV cases,” or have long-lived antibodies in their circulation. © 1996 Wiley-Liss, Inc.     

TGF-β1 and contact mediated suppression by CD4+CD25+CD127− T regulatory cells of patients with self-limiting hepatitis E

Background and aimLiterature on the role of Regulatory T cells (Tregs) in acute viral infections is limited. Having established that the Tregs in self-limiting hepatitis E infection are elevated and functional, this study has focused on characterizing the specificity, phenotypes and identifying the molecules or factors responsible for enhancement of Treg cells and abrogation of Treg-mediated suppression in hepatitis E.MethodsHEV rORF2p specific (a) Treg frequency, subset analysis and expression of surface and intracellular markers on Tregs and CFSE based functional analysis by flow cytometry (b) key cytokines quantification by multiplex (c) suppressive functional assay in the presence of anti-TGF-β₁ or anti-IL-10 or both antibodies or Transwell insert or in combination were performed on samples from 58 acute patients (AVH-E), 45 recovered individuals from hepatitis E and 55 controls.ResultsIn AVH-E, the increased frequencies of Tregs and Teff cells were HEV rORF2p specific and Treg cells were of effector memory phenotype. Higher expressions of HEV rORF2p stimulated CTLA-4, GITR, PD1L, CD103, CD39, TLR2 and TGF-β₁ molecules on Tregs of AVH-E were observed. Tregs produced TGF-β₁ and inhibited the secretion of IFN-γ. Transwell insert and cytokines blocking assays indicated Tregs mediated suppression in AVH-E patients is majorly TGF-β₁ mediated and partly cell-cell contact mediated.ConclusionOverall, we have identified beneficial involvement of HEV specific, functional Tregs and TGF-β₁ as the regulatory molecule responsible for enhancement of Tregs in self-limiting HEV infection. Therefore, use of TGF-β₁ as a possible supplement for boosting Treg response in recovery from severe hepatitis E needs evaluation.     

Evaluation of antibody-based and nucleic acid-based assays for diagnosis of hepatitis E virus infection in a rhesus monkey model

We have evaluated four hepatitis E virus (HEV) specific antibody assays, using sequential samples taken from 86 rhesus monkeys at intervals for up to 86 weeks after they had been infected with different doses of HEV. The animals are a common experimental model of hepatitis E. The large collection of sequential samples used avoids uncertainties encountered in previous studies regarding the precise infection status of study subjects and minimizes bias due to the individuality of response to infection. One assay (YES IgG) was produced with synthetic peptides; the others (E2 IgM, E2 IgG, and GL IgG) were produced with recombinant antigens. The results were compared with the viral RNA contents of the serum and stool samples and the occurrence of these virological and immunological markers in the course of the infection was temporally related to the development of hepatitis. Diagnostic utility of the markers was assessed according to their response rates and prevalence at different times in the course of infection. All the animals produced E2 IgG and developed viremia and all but one also produced E2 IgM and excreted the virus in stool, whereas response rates for the other antibodies were lower and decreased with virus dose. Hepatitis occurred over a period of 4 weeks between 3 and 7 weeks after infection. Virological activity occurred mainly during the incubation period and the prevalence of viral markers declined rapidly after the onset of hepatitis. Production of the E2 antibodies immediately preceded the onset of hepatitis, and this was followed about one week later by production of the other antibodies. Seroprevalence E2 IgM reached a peak value 3 weeks after the onset of hepatitis, whereas seroprevalence of GL IgG and YES IgG peaked after the disease had subsided. E2 IgG persisted in all animals for the entire duration of the experiment of up to 86 weeks and possibly beyond and, thus, can serve as a useful epidemiological marker of HEV infection.     

Differences in capabilities of different enzyme immunoassays to detect anti-hepatitis E virus immunoglobulin G in pigs infected experimentally with hepatitis E virus genotype 3 or 4 and in pigs with unknown exposure

Hepatitis E virus (HEV), a major cause of acute viral hepatitis in humans in many developing countries, is highly prevalent in the pig population worldwide. The objective of this study was to assess the capability of three porcine prototypes of a human enzyme-linked immunosorbent assay (ELISA), an in-house ELISA and a line-immunoassay (LIA) to detect anti-HEV antibodies in pigs infected experimentally with HEV (n = 57), known to be negative for HEV infection (n = 27), or with unknown exposure to HEV infection (field samples, n = 90). All 27 samples from non-infected pigs were negative with all five assays. The earliest detection of anti-HEV antibodies occurred at 14 days post-inoculation (dpi) with four of five assays. From 42 dpi, all samples from infected pigs were detected correctly as anti-HEV positive. Kappa analysis demonstrated substantial agreement among tests (0.62-1.00) at 14 dpi and complete agreement (1.00) at 56 dpi. The overall area under the curve for all quantitative tests as determined by receiver operator characteristic analysis ranged from 0.794 to 0.831 indicating moderate accuracy. The results showed that all five assays can detect anti-HEV IgG antibodies accurately in pigs infected experimentally with HEV. In field samples, a higher prevalence of anti-HEV IgG was found in breeding herds than in growing pigs (100% versus 66.7-93.9%). These serological assays should be very useful in veterinary diagnostic labs for HEV diagnosis in swine.     

Hepatitis E virus infection in developed countries

Hepatitis E was considered to be endemic infectious disease in developing countries in tropical or subtropical regions with poor sanitary conditions. Large, previously reported outbreaks were mainly due to contaminated water or heavy flooding. Prototype hepatitis E viruses of genotypes I and II were obtained from such endemic cases. In developed countries, in contrast, hepatitis E was rare and diagnosed only in travelers or imported cases. However, the development of accurate diagnostic tests, mainly PCR detection elucidated that autochthonous hepatitis E in developed countries is far more common than previously thought. Although the main route of transmission is food-borne, other routes including blood-borne have been suggested. Recent developments of gene-based diagnostic assays and molecular epidemiology have disclosed the significance of hepatitis E virus infection in developed countries.     

Acute hepatitis E virus infection in Taiwan 2002–2006 revisited: PCR shows frequent co‐infection with multiple hepatitis viruses

Sporadic cases of acute hepatitis E virus (HEV) infection with production of anti‐HEV IgM have been reported occasionally in Taiwan despite no reported outbreaks in the past. This study was undertaken to determine whether serological markers correlated with virus detection. From 2002 to 2006, 72 reported cases of acute hepatitis E seropositive for anti‐HEV IgM in Taiwan were enrolled for investigation. Acute phase serum samples were collected for detection of HEV RNA, HBV DNA, HCV RNA, and GBV‐C RNA by PCR. The results showed that viral sequences of HEV, HBV, HCV and GBV‐C were detected in 54 (75%), 21 (29.2%), 9 (12.5%), and 22 (30.6%) of cases, respectively. Acute hepatitis A co‐infection was excluded in all patients because none were seropositive for anti‐HAV IgM and, nine patients (12.5%) did not seroconvert to anti‐HEV IgG. These results suggest that serum markers did not correlate completely with viremia in the diagnosis of acute HEV infection. Multiple viruses may co‐infect with acute hepatitis E virus in Taiwan. Detection of hepatitis E viremia together with seropositivity for anti‐HEV IgM and followed by seroconversion to anti‐HEV IgG should be included in the diagnostic criteria for HEV infection. J. Med. Virol. 81:1734–1742, 2009. © 2009 Wiley‐Liss, Inc.     

Development and validation of a genotype 3 recombinant protein-based immunoassay for hepatitis E virus serology in swine

Hepatitis E virus (HEV) is classified within the family Hepeviridae, genus Hepevirus. HEV genotype 3 (Gt3) infections are endemic in pigs in Western Europe and in North and South America and cause zoonotic infections in humans. Several serological assays to detect HEV antibodies in pigs have been developed, at first mainly based on HEV genotype 1 (Gt1) antigens. To develop a sensitive HEV Gt3 ELISA, a recombinant baculovirus expression product of HEV Gt3 open reading frame-2 was produced and coated onto polystyrene ELISA plates. After incubation of porcine sera, bound HEV antibodies were detected with anti-porcine anti-IgG and anti-IgM conjugates. For primary estimation of sensitivity and specificity of the assay, sets of sera were used from pigs experimentally infected with HEV Gt3. For further validation of the assay and to set the cutoff value, a batch of 1100 pig sera was used. All pig sera were tested using the developed HEV Gt3 assay and two other serologic assays based on HEV Gt1 antigens. Since there is no gold standard available for HEV antibody testing, further validation and a definite setting of the cutoff of the developed HEV Gt3 assay were performed using a statistical approach based on Bayes'' theorem. The developed and validated HEV antibody assay showed effective detection of HEV-specific antibodies. This assay can contribute to an improved detection of HEV antibodies and enable more reliable estimates of the prevalence of HEV Gt3 in swine in different regions.     

Seroprevalence of hepatitis E antibodies in a population of recyclable waste pickers in Brazil

BackgroundHepatitis E virus (HEV) infection represents an important cause of acute viral hepatitis. Selective waste collection is a widespread activity carried out by the urban poor, and recyclable waste pickers have a lifestyle that makes this group highly vulnerable to unfavorable socio-economic and environmental factors. To date, the epidemiology of HEV infection in this population remains unknown.ObjectivesTo assess the seroprevalence of hepatitis E-specific antibodies in a population of recyclable waste pickers in Brazil.Study designBetween April 2010 and May 2011, a cross-sectional study was conducted among recyclable waste pickers from all 15 recycling cooperatives in Goiânia City, Central Brazil. The participants were tested for serological markers indicative of HEV infection.ResultsOf 432 individuals asked to participate in the survey, 431 (99.8%) agreed to participate. Twenty-four of 431 participants were anti-HEV IgG positive by ELISA. Of these, 22 were confirmed positive by immunoblot, resulting in an anti-HEV IgG prevalence of 5.1% (95% CI: 3.4–7.6). In addition, four individuals were anti-HEV IgM positive by ELISA. Of these, three (0.7%; 95% CI: 0.4–2.4) were confirmed anti-HEV IgM positive by immunoblot, but were HEV RNA negative. One was concurrently positive for anti-HEV IgG. Only age > 40 years was independently associated with the presence of anti-HEV.ConclusionsThese findings demonstrated that the prevalence of HEV antibodies among recyclable waste pickers in Central Brazil is relatively low and increased with age.     

Identifications of polyphyletic variants in acute hepatitis suggest an underdiagnosed circulation of hepatitis E virus in Argentina

Background

In recent years, an increasing number of infections with genotype 3 hepatitis E virus (HEV) have been reported in western countries. Data in South America, however, are still scarce. Swine and human variants previously described in Argentina are closely related to a human Austrian one.

Objective

To identify whether HEV is still circulating in Argentina.

Study design

Sera and stool samples from adults and children with unexplained acute liver disease referred to our center during the last six years were prospectively studied. Dual infection with hepatitis A was retrospectively studied in a group of children with fulminant hepatic failure.

Results

Fifteen new cases (13 adults and 2 children), seven of whom required hospitalization, were diagnosed. Nine had detectable HEV RNA, and one had imported genotype 1. Subgenotype 3i HEV-related variants are still circulating. Five autochthonous sequences, related to European, American and Japanese ones, grouped in subgenotype 3a. One case had a subgenotype 3b variant.

Discussion

The polyphyletic variants widespread in Argentina suggest multiple sources of infection. Whether or not their reservoir is swine merits further investigation. Since hepatitis E is still considered rare, differential laboratory testing in unexplained acute liver disease is not routinely performed in Argentina. Broadening awareness of this disease is important in light of the decrease in hepatitis A incidence since universal vaccination was implemented in 2005. The diagnosis of hepatitis E with a combination of serological and molecular tools is needed to better understand its epidemiology and impact on the clinical management of patients with unexplained increased transaminases.     

Epstein–barr virus associated acute hepatitis with cross‐reacting antibodies to other herpes viruses in immunocompetent patients: Report of two cases

Epstein–Barr virus (EBV) is the causative agent of infectious mononucleosis (IM) which is characterized by the triad of fever, sore throat, and lymphadenopathy. Self‐limited, mild liver function test abnormalities are seen in IM. Acute hepatitis in primary EBV infection is uncommon. Serum transaminases are elevated but are less than fivefold the normal levels in most cases and rarely exceed 10 times the normal levels in primary EBV infections especially in elderly. Laboratory diagnosis of acute EBV infection is by serological assays confirming the presence of EBV viral capsid antigen (VCA) IgM antibodies. Due to antigenic cross‐reactivity with Herpes viruses, serological assays lack specificity; hence specific molecular diagnostic methods are required for confirmation of the etiology. The present report describes two cases of acute hepatitis caused by infection with EBV which had indistinguishable clinical features and biochemical markers from acute hepatitis caused by hepatotropic viruses such as hepatitis viruses A–E. The diagnosis of infection by EBV was confirmed by detection of EBV DNA in blood of both the patients and EBV DNA in the liver tissue of one of the patients. J. Med. Virol. 85:519–523, 2013. © 2013 Wiley Periodicals, Inc.     

Hepatitis E virus infection: Epidemiology and treatment implications

Hepatitis E virus(HEV) infection is now established as an emerging enteric viral hepatitis. Standard treatments in acute and chronic hepatitis E remain to be established. This study undertakes a review of the epidemiology, treatment implication and vaccine prevention from published literature. HEV infection is a worldwide public health problem and can cause acute and chronic hepatitis E. HEV genotypes 1 and 2 are primarily found in developing countries due to waterborne transmission, while the zoonotic potential of genotypes 3 and 4 affects mostly industrialized countries. An awareness of HEV transmission through blood donation, especially in the immunocompromised and solid organ transplant patients, merits an effective anti-viral therapy. There are currently no clear indications for the treatment of acute hepatitis E. Despite concerns for side effects, ribavirin monotherapy or in combination with pegylatedinterferon alpha for at least 3 mo appeared to show significant efficacy in the treatment of chronic hepatitis E. However, there are no available treatment options for specific patient population groups, such as women who are pregnant. Vaccination and screening of HEV in blood donors are currently a global priority in managing infection. New strategies for the treatment and control of hepatitis E are required for both acute and chronic infections, such as prophylactic use of medications, controlling large outbreaks, and finding acceptable antiviral therapy for pregnant women and other patient groups for whom the current options of treatment are not viable.     

Hepatitis E virus antigen detection as an early diagnostic marker: Report from India

Hepatitis E virus (HEV) is implicated in many outbreaks of viral hepatitis in the Indian subcontinent. The conventional diagnosis of such outbreaks rests on the detection of anti‐HEV IgM antibodies. However, IgM antibodies develop after 4–5 days of infection. An early‐diagnostic marker is imperative for timely diagnosis of the outbreak and also initiation of control measures. This study aimed to determine the use of hepatitis E virus antigen detection as an early diagnostic marker in an outbreak in comparison to anti‐HEV IgM and RT‐PCR analyses. Forty samples were collected during a suspected outbreak of viral hepatitis due to HEV. A total of 36 samples were positive for one or more HEV markers. The positivity for anti‐HEV IgM, HEV antigen, and RT‐PCR was 91.6%, 69.4%, and 47.2% respectively. RT‐PCR and HEV antigen detection gave the highest positive results (100%) in the first 3 days of illness. Positive HEV PCR declined to 54% by Days 4–7, whereas HEV antigen and IgM detection were 88% and 100%, respectively. Sequencing of representative HEV samples indicated that the strains responsible for this outbreak belonged to genotype I, subtype 1a. HEV antigen was found to be an early diagnostic marker of acute infection. HEV antigen was detected in three additional cases in the early phase (1–3 days), and they had no detectable anti‐HEV IgM antibodies. These three samples were also positive for HEV RNA. After Day 7, anti‐HEV IgM was the main diagnostic indicator of infection. J. Med. Virol. 85:823–827, 2013. © 2013 Wiley Periodicals, Inc.     

Incidence and seroprevalence of hepatitis E virus infection in pregnant women infected with hepatitis B virus and antibody placental transfer in infants

BackgroundHepatitis E has poor outcomes in pregnant women. Superinfection of hepatitis E virus (HEV) in patients infected with hepatitis B virus (HBV) may worsen liver disease.ObjectivesTo estimate the incidence and seroprevalence of HEV infection among HBV-infected pregnant women, to investigate the transplacental transfer of maternal anti-HEV IgG, and to compare the maternal and neonatal outcomes in anti-HEV positive and negative pregnant women.Study designTotally 391 HBV-infected pregnant women were recruited from April 2012 to October 2014. Paired mothers and infants were followed up at an average 9.8 months postpartum. Anti-HEV IgG and IgM were tested by ELISA.ResultsOf the pregnant women, none was anti-HEV IgM positive and 42 (10.7%) were IgG positive. At the follow-up, 3 seronegative women converted to anti-HEV IgG positive, with an estimated incidence of 17 per 1000 person-years. No significant differences of gestational age, preterm birth rate, Apgar score and birthweight were observed between newborns of anti-HEV IgG positive and negative mothers. Of the 42 neonates born to anti-HEV IgG positive mothers, 38 (90.5%) had anti-HEV IgG in their cord blood. The neonatal and maternal anti-HEV IgG levels were positively correlated (r = 0.827, p < 0.05). All infants were negative for both anti-HEV IgM and IgG at the follow-up.ConclusionsHBV-infected pregnant women rarely have novel HEV infection during late pregnancy in Jiangsu, China. Maternal anti-HEV IgG efficiently transfers into the fetuses, and disappears in infants before 10 months old.     

Hepatitis E virus coinfection with hepatotropic viruses in Egyptian children

BACKGROUND AND PURPOSE: Major hepatotropic viruses continue to be important causes of acute viral hepatitis in developing countries. This work was carried out to detect the seroprevalence of hepatitis E virus (HEV) markers in children with acute viral hepatitis due to hepatotropic viruses (A, B and C) and non-A, non-B, non-C acute hepatitis, and to ascertain the influence of HEV superinfection in individuals infected with hepatitis viruses (A, B and C). METHODS: We studied prospectively 162 children with sporadic acute hepatitis who reported to our hospital. Thirteen healthy controls were also included in the study. Laboratory investigations were performed, including complete liver function tests. Complete serological profiles for hepatitis viruses A, B, C and E were evaluated. RESULTS: HEV immunoglobulin G was detected with highest percentage among patients with hepatitis B (56.7%), followed by patients with hepatitis C virus (52.0%), hepatitis A virus (34.1%) and combined hepatitis B and C viruses (30.0%). The detection rate among patients with non-A, non-B, non-C hepatitis was 7.1%. HEV immunoglobulin M was found in 4.5% of hepatitis A virus patients and in 3.3% of hepatitis B patients. The prevalence of HEV immunoglobulin G and immunoglobulin M correlated with the levels of hepatic aspartate aminotransferase and alanine aminotransferase in patients with dual markers of infection with hepatitis E and other viruses compared to patients with acute hepatitis due to A and C viruses. CONCLUSIONS: HEV serological markers are common among children with acute viral hepatitis, especially from hepatitis C and B viruses. There may be increased sensitivity to HEV coinfection in association with hepatitis B and C infections. Dual infection with HEV and other hepatotropic viruses was associated with greater elevation of aspartate and alanine aminotransferases.     

Hepatitis E virus: the cause of a waterbourne hepatitis outbreak.

Newly developed assays for antibody to hepatitis E virus (HEV) were used to study 114 serum samples collected during an outbreak of enterically transmitted hepatitis that occurred in Kashmir in 1978/9. The sera included samples from patients with viral hepatitis, anicteric hepatitis, contacts of cases, and unaffected persons. A total of 71% of patients with viral hepatitis were found positive for anti-HEV specific IgG, and 75% of these were also positive for IgM. These data confirm the hepatitis E virus as the causative agent in this outbreak.     

我国戊型肝炎ELISA诊断试剂的质量比较

目的对戊型肝炎(戊肝)诊断试剂进行质量评价。方法选择北京万泰生物药业(万泰),北京现代高达生物技术(高达),上海科华生物工程(科华),GeneLabs Diagnostic Inc(GeneLabs),和河南华美生物工程(华美)共5家公司生产的检测戊肝病毒IgG(HEV-IgG)抗体的ELISA试剂,分别检测戊肝诊断试剂参比品、可疑戊肝临床患者和正常人群血清HEV抗体。结果对24份阳性和30份阴性参比品检测,以万泰试剂检测符合率最高,阳性和阴性符合率分别为95.83%(23/24)和96.67%(29/30),总符合率为96.30%,其次为高达试剂87.50%(21/24)和100%(30/30),总符合率为94.44%,华美试剂87.50%(21/24)和96.67%(29/30),总符合率92.59%,GeneLabs66.67%(16/24)和100%(30/30),总符合率为85.18%,科华试剂45.83%(11/24)和100%(30/30),总符合率为75.93%。对42份可疑戊肝患者血清HEV抗体检测阳性率,高达试剂为100%(42),万泰和华美试剂均为97.62%(41),GeneLabs和科华试剂均为90.48%(38)。对230份正常人群HEV抗体检测阳性率,从高到低依次为万泰试剂31.74%(73),华美试剂为23.91%(55),高达试剂为17.39%(40),GeneLabs和科华试剂分别是7.83%(18)和3.48%(8)。结论5家试剂检测急性期戊肝患者抗体阳性率均能达90%以上,具有很高的一致率,而应用于普通人群HEV感染的调查,其抗体阳性率从31.74%~3.48%不等。不同的试剂存在假阳性或和阳性漏检现象。依本室参比品和人群血清阳性率来看,万泰试剂检出率较高。