Comparison of Two Automated Immunoassays for the Detection of Anti-Hepatitis A Virus Total Immunoglobulin and IgM / 임상검사와정도관리

BACKGROUND: The detection of total anti-hepatitis A virus (anti-HAV) immunoglobulin (Ig) and IgM is important for diagnosing acute hepatitis A. Our laboratory introduced new commercial automated chemiluminescence immunoassays (CLIAs) for use in addition to pre-existing automated CLIA. We evaluated the rate of agreement in the detection of total anti-HAV Ig and IgM in serum samples between two automated CLIAs. METHODS: We analyzed 181 samples those were submitted for testing at Kangbuk Samsung Medical Center. We analyzed the rate of agreement between the ADVIA Centaur XP (Siemens, Germany) and the MODULAR ANALYTICS E170 (Roche, Switzerland) analyzers. We performed reverse transcription (RT)-PCR when there was a discrepancy between the results from the two analyzers. RESULTS: The agreement rates between the ADVIA Centaur XP and the MODULAR ANALYTICS E170 for total anti-HAV Ig and IgM were 97.2% and 98.9%, respectively. Discrepant results were obtained in seven cases; all were found to be HAV-negative based on RT-PCR analysis. CONCLUSIONS: The total anti-HAV Ig and IgM results obtained using the two automated analyzers were comparable. However, in cases of equivocal results tested by the ADVIA Centaur XP for anti-HAV IgM, retesting and follow-up testing of samples are recommended.

Evaluation of Serologic Markers for HBV Infection Using Roche Modular Analytics E170 / 임상검사와정도관리

BACKGROUND: Hepatitis B virus (HBV) infection is the leading cause of liver disease in Korea and, is usually diagnosed with serologic testings. The automated immunoassay analyzer, Roche Modular Analytics E170 (Roche Diagnostics, Mannheim, Germany; E170) tests HBV serologic markers based on electrochemiluminescence (ECL) method. We would like to evaluate analytical performances of E170 for HBV serologic markers. METHODS: We evaluated the precision of E170 for 6 serologic markers (HBsAg, anti-HBs, HBeAg, anti-HBe, IgG anti-HBc, IgM anti-HBc) with positive pooled serum. A comparison study with the AxSym immuoassay analyzer (Abbott Laboratories, Abbott Park, IL USA) was performed using patient's sera. HBsAg confirm test was evaluated using the specimens with cutoff index (COI) between 1 and 10 for HBsAg. RESULTS: The total coefficients of variations were below 5% for all of the 6 serologic markers. Method comparisons between E170 and AxSYM showed a good concordance rate; the rates of positive and negative agreements were more than 90% for almost all the serologic markers. HBsAg confirm tests for 84 samples with COI between 1 and 10 revealed that only 36 samples (43%) were true positive for HBsAg. Among 36 true positive samples, 9 samples (25%) were anti-HBs positive concurrently, but these showed low antibody titer (<50 IU/L). CONCLUSIONS: The E170 showed good precision for all HBV serologic markers and a high concordance rate with the AxSYM. Therefore, E170 can be used as a routine immunoassay analyzer for the testing of HBV serologic markers. In addition, HBsAg confirmatory test might be useful to confirm the true positivity when a specimen has low cut-off index (1-10).