JOURNAL OF SHANDONG UNIVERSITY (HEALTH SCIENCES)

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Domestic fluorescence quantitative PCR reagents and COBAS Amplicor assay in measuring HBVDNA: a comparison study

XUE Yan1，　WANG Lei1，　XU Wansu2
   

  1. (1. Department of Infectious Disease, Second Hospital of Shandong University, Jinan 250033, China;
    2. Department of Clinical Laboratory, Jinan Hospital of Infectious Disease, Jinan 250021, China)
  • Received:1900-01-01 Revised:1900-01-01 Published:2009-04-16
  • Contact: WANG Lei

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Abstract: To compare the efficacy of two domestic real time fluorescence quantitative PCR(FQPCR) diagnostic kits and COBAS Amplicor HBVDNA monitor for HBVDNA determination. MethodsSerum samples from 151 patients with chronic hepatitis B were determined by COBAS Amplicor HBVDNA monitor (A). The serum samples were retested by FQPCR with domestic reagents (B and C). Concordance and correlation of the results were assessed and sensitivity and specificity of B and C were evaluated. ResultsThe serum HBVDNA levels determined by reagent A, B and C were (5.87±1.64)， (5.11±1.34), (4.93±1.35) log10?copies/mL, respectively (P＜0.05). And the HBVDNA level determined by A was higher than either of the latter two (P＜0.05)， while that by B and C were comparable (P＞0.05). The correlative coefficiency between results by A and B, and A and C were 0.947 and 0.937, respectively. Correlation between B, C and A in low virus load samples was not as good as that in high load samples. Overall sensitivity of reagent B and C was 90.4％ and 77.0%, and overall specificity was 56.3% and 100%, respectively. ConclusionBoth of the domestic fluorescence quantitative PCR reagents are fairly good in measuring serum HBVDNA, while they are less reliable in low virus load samples. Regent B is more sensitive and C is more specific.

Key words: Hepatitis B virus, Fluorescence quantitative PCR, Sensitivity, Specificity

CLC Number: 

  • R446.61
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