Differential diagnosis of acute viral hepatitis using rapid, fully automated immunoassays

Eble, K S; Clemens, John; Krenc, Christine; Rynning, Michael D.; Stojak, Joseph; Stuckmann, Janice; Hutten, Patricia; Nelson, Linda S.; Ducharme, Louise; Hojvat, Sally; Mimms, Larry

doi:10.1002/jmv.1890330302

Cited by 36 publications

(30 citation statements)

References 25 publications

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“…Serum IgM anti-HBc was determined by a commercially available, microparticle, enzyme immunoassay in an IMx analyzer (IMx CORE-M; Abbott Labs., Chicago, IL); the IgM anti-HBc index value, which allows for a semiquantitative evaluation of the serum IgM anti-HBc concentrations, was used in the analysis. 12 Serum HBV DNA levels were determined by a commercially available quantitative PCR assay (Amplicor HBV Monitor Test; Roche Diagnostics, GmbH Mannheim, Germany); the sensitivity of this assay according to the manufacturer is about 400 copies/mL. 13 Sequencing of HBV genome for YMDD mutations was performed on any occasion of virologic breakthrough in serum samples drawn at the onset of breakthrough.…”

Section: Methodsmentioning

confidence: 99%

Course of virologic breakthroughs under long-term lamivudine in HBeAg-negative precore mutant HBV liver disease

et al. 2002

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We studied the course of virologic breakthroughs detected by a quantitative polymerase chain reaction (PCR) assay in 32 of 78 patients with hepatitis B e antigen (HBeAg)-negative precore mutant hepatitis B virus (HBV) chronic liver disease under long-term lamivudine monotherapy. Serum HBV DNA levels were measured every 3 months and on every biochemical breakthrough. YMDD mutants were detected in 30 of the 32 patients with virologic breakthroughs. Among these 32 patients, biochemical remission rate was 44% at 6 months, 21% at 12 months, and 0% at 24 months after the onset of virologic breakthrough. Development of biochemical breakthroughs was associated with a significant increase of serum HBV DNA levels, which exceeded 100,000 copies/mL in 19 of 20 patients (95%) with biochemical breakthroughs and in only 1 of 8 patients (12.5%) remaining in biochemical remission for at least 6 months after the onset of virologic breakthrough (P < .001). Alanine aminotransferase (ALT) level peaked within 0 to 3 months after the onset of biochemical breakthrough and decreased at 6 months but remained abnormal in all but 2 patients. Follow-up liver histologic lesions in patients with biochemical breakthroughs did not differ from baseline findings, although they were significantly improved in patients remaining in virologic and biochemical remission. In conclusion, the frequent emergence of viral resistance under long-term lamivudine monotherapy in HBeAg-negative precore mutant HBV chronic liver disease is followed by increasing viremia levels culminating in the development of biochemical breakthroughs in most cases. ALT activity peaks close to the onset of biochemical breakthrough, decreasing thereafter but remaining persistently abnormal with fluctuating levels. (HEPATOLOGY 2002;36:219-226.)

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Section: Methodsmentioning

confidence: 99%

Course of virologic breakthroughs under long-term lamivudine in HBeAg-negative precore mutant HBV liver disease

et al. 2002

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“…This procedure was costly, time-consuming, and did not allow precise quantification of the low anti-HBc IgM levels which may occur in the patients with chronic HBV infection. Recently, a microparticle EIA has provided rapid and reproducible semiquantitative measures of serum anti-HBc IgM even at low concentrations [Eble et al, 1991;Brunetto et al, 1993;Hadziyannis et al, 1993;Marinos et al, 19941. Using this method, some longitudinal studies examined the significance of serum anti-HBc, IgM levels in adult patients with chronic HBV infection and found that an anti-HBc IgM response is associated to hepatocellular damage [Brunetto et al, 1993;Marinos et al, 19941.…”

Section: Introductionmentioning

confidence: 99%

Semiquantitative anti‐HBc IgM detection in children with chronic hepatitis B: A long‐term follow‐up study

Gaeta

Nardiello

Pizzella

et al. 1995

Journal of Medical Virology

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Serum anti-HBc IgM titres were monitored monthly by a semiquantitative method in 14 children with HBeAg positive chronic hepatitis B followed up for 18-65 months. All patients, but one, were treated with alfa-interferon (IFN) at different times. On the whole, 12 flare-up episodes were observed and 7 patients cleared HBV-DNA and seroconverted to anti-HBe. Seroconversion occurred only in patients with pretreatment anti-HBc IgM index greater than 0.15 and serum HBV-DNA concentration below 100 pg/ml; the pretreatment alanine aminotransferase (ALT) value was not predictive of response. Combining anti-HBc IgM results and serum HBV-DNA levels observed during the pre-IFN period allowed a precise identification of patients who were likely to respond to IFN therapy. Patients who seroconverted to anti-HBe showed a progressive reduction in serum anti-HBc IgM titres within 6 months. Interestingly, one child, in whom HBV-DNA reappeared and who reconverted to HBeAg 7 months after treatment, showed no anti-HBc IgM decrease after the transient clearance of HBV-DNA and anti-HBe seroconversion. Semiquantitative anti-HBc IgM detection is a useful tool in the decision making process for children with chronic hepatitis B.

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“…The results of the MEIA are expressed as index values (ratio of sample to calibrator) (9), and the results of the CMIA are in relative light units divided by the cutoff value determined in the preceding calibration (21).…”

mentioning

confidence: 99%

“…Although commercially available anti-HBc IgM assays have been developed and marketed for the diagnosis of acute HBV infection (9,19), anti-HBc IgM titers are used for the differentiation between "inactive HBsAg carriers" and patients with HBeAg-negative CHB. In this study, we showed that two MEIA methods and one CMIA method for the quantification of serum anti-HBc IgM have good performance characteristics with low variation and no positive interference with RF but that individual results deviate significantly.…”

mentioning

confidence: 99%

Performance Characteristics of Microparticle Enzyme and Chemiluminescence Immunoassays for Measurement of Anti-HBc Immunoglobulin M in Sera of Patients with HBeAg-Negative Chronic Hepatitis B Virus Infection

Hadziyannis

Manesis

Vassilopoulos

et al. 2008

Clin Vaccine Immunol

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The IMx, AxSym, and Architect immunoglobulin M anti-HBc assay systems for detecting hepatitis B virus e antigen-negative chronic hepatitis B virus infection were compared. Despite good intra-and interassay coefficients of variation, significantly different values and low correlation (overestimation by AxSym and underestimation by Architect) were observed. Association and cutoff values for distinguishing patients with viral replication should be established for all methods.In patients with hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection, absolute levels and changing titers of immunoglobulin M antibodies against the HBV core protein (anti-HBc IgM) are considered markers of viral replication (11,13,17). The measurement of anti-HBc IgM is an easily performed and inexpensive alternative to frequent serum HBV DNA measurements for monitoring untreated patients, as well as patients treated with alpha interferon or antiviral agents (1, 5, 11-13, 15-18, 20).Most experience in the detection of anti-HBc IgM in patients with chronic hepatitis B (CHB) is based on microparticle enzyme immunoassays (MEIA) using the IMx analyzer. Most anti-HBc IgM values for patients with HBeAg-negative chronic HBV infection are below the cutoff limit for a diagnosis of acute hepatitis B, either in the negative or in the "gray" zone. When determined by a classic enzyme-linked immunosorbent assay, they range from 20 to 600 U/ml (10), and when tested with a MEIA (the IMx system), the results range from index values of 0.2 to 2.0, approximately 10 to 300 U/ml (1, 7).In most laboratories, the IMx analyzer has been replaced by the AxSym analyzer (MEIA), and newer analyzers with chemiluminescent assays (CMIA) are gradually being instituted (4, 6, 21). We compared the anti-HBc IgM measurements by the three analyzers for patients with HBeAg-negative chronic HBV infection.The IMx (MEIA), AxSym (MEIA), and Architect (CMIA) analyzers (Abbott Laboratories, Abbott Park, IL) were used for anti-HBc IgM quantification. The results of the MEIA are expressed as index values (ratio of sample to calibrator) (9), and the results of the CMIA are in relative light units divided by the cutoff value determined in the preceding calibration (21).For the evaluation of the inter-and intra-assay variation (coefficient of variation [CV]), we used multiple aliquots of sera from three patients with HBeAg-negative CHB (patients P1 to P3). Each serum sample was tested five times in the same assay and five times over five days with each of the three analyzers. Anti-HBc IgM measurements for 53 consecutive patients with HBeAg-negative chronic HBV infection were compared. The influence of rheumatoid factor (RF) measured by nephelometry (Immage immunochemistry systems; Beckman Coulter, Inc., Fullerton, CA) was assessed.For data entry, frequencies, and comparisons, SPSS version 14.0 (SPSS, Inc., Chicago, IL) was used. The t test and the Mann-Whitney test were applied for parametric and nonparametric data comparisons, respectively. For paired compa...

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Differential diagnosis of acute viral hepatitis using rapid, fully automated immunoassays

Cited by 36 publications

References 25 publications

Course of virologic breakthroughs under long-term lamivudine in HBeAg-negative precore mutant HBV liver disease

Course of virologic breakthroughs under long-term lamivudine in HBeAg-negative precore mutant HBV liver disease

Semiquantitative anti‐HBc IgM detection in children with chronic hepatitis B: A long‐term follow‐up study

Performance Characteristics of Microparticle Enzyme and Chemiluminescence Immunoassays for Measurement of Anti-HBc Immunoglobulin M in Sera of Patients with HBeAg-Negative Chronic Hepatitis B Virus Infection

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