Performance Characteristics and Comparison of Abbott and artus Real-Time Systems for Hepatitis B Virus DNA Quantification

Ismail, Ashrafali Mohamed; Sivakumar, Jayashree; Raghavendran, Anantharam; Dayalan, Sujitha; Samuel, Prasanna; Fletcher, Gnanadurai John; Gnanamony, Manu; Abraham, Priya

doi:10.1128/jcm.00915-11

Cited by 36 publications

(22 citation statements)

References 10 publications

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“…Retrospective analysis with the highly sensitive method also revealed samples with values above the lower-detection limit of the in-house-test. This is in concordance with previous findings, that in real-life settings, low input volumes in extraction as well as PCR lead to a higher variation and often lower test sensitivity [17]. The robustness of highly sensitive real-time tests with high input volumes favours these tests for reliable therapy monitoring.…”

Section: Methodssupporting

confidence: 92%

“…In chronic hepatitis B, highly sensitive real-time PCR techniques with a lower limit of detection of 10–20 IU/mL [17]–[20] allow quantification of minimal residual viremia which could not be detected in the registration trials of the potent nucleos(t)ide analogues entecavir, telbivudine, and tenofovir which were performed with conventional PCRs with a lower limit of detection between 60–80 IU/mL [3]–[6]. Applying real-time PCR in clinical routine, clinicians become confronted with positive HBV-DNA results in patients who seemed to be successfully treated with NUCs so far and were always HBV-DNA negative determined by conventional PCR.…”

Section: Discussionmentioning

confidence: 99%

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Clinical Relevance of Minimal Residual Viremia during Long-Term Therapy with Nucleos(t)ide Analogues in Patients with Chronic Hepatitis B

et al. 2013

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BackgroundSuccessful therapy of chronic hepatitis B with nucleos(t)ide analogues (NUCs) has been defined by undetectable HBV-DNA determined with conventional PCR (lower limit of detection (LLD) 60–80 IU/mL) in clinical registration trials. However, current EASL guidelines recommend highly sensitive real-time PCR (LLD<10–20 IU/mL) and define treatment response by HBV-DNA<10 IU/mL.AimWe evaluated frequency and relevance of minimal residual viremia (MRV) during long-term NUC-treatment in a real-life setting.MethodsFrozen serum samples (HBV-DNA negative by in-house PCR, LLD <73 IU/mL) were re-analyzed by real-time PCR (LLD<10 IU/mL, Abbott, Germany). MRV was defined by real time PCR positivity and conventional PCR negativity.Results237 samples of six HBsAg carriers and 27 NUC-treated CHB patients were analyzed (treatment period 28 (11–111) months, different treatment regimens with mono- or combination therapy). MRV was detected in 31/33 individuals (n = 160/237 serum samples) and more frequent in HBsAg carriers (95%) and HBeAg positive (87%) compared to HBeAg negative patients (53%) (p<0.0001, respectively). Five HBsAg carriers, five HBeAg positive, and four HBeAg negative individuals were continuously HBV-DNA positive. MRV was not significantly more often observed during NUC-monotherapies compared to combination therapies. Concomitant immunosuppressive therapy was present in nine cases and did not influence the results. Viral resistance occurred in three immunocompetent patients with adefovir or lamivudine monotherapy.ConclusionsMRV is frequently observed during long-term NUC-therapy. Adjustment of treatment with highly potent NUCs does not seem to be necessary in case of minimal residual viremia in a real-life setting.

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Section: Methodssupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Clinical Relevance of Minimal Residual Viremia during Long-Term Therapy with Nucleos(t)ide Analogues in Patients with Chronic Hepatitis B

et al. 2013

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“…The lower limit of detection (LLD) in using the Qiamp DNA Blood Mini kit (Qiagen GmbH, Hilden, Germany) and the artus ® HBV Rotor-Gene Polymerase Chain Reaction (RG PCR) assay was determined to be 82 IU/mL (95% detection limit) in our centre. [11] HBVrt amplifi cation and sequencing…”

Section: Hbv Dna Quantifi Cationmentioning

confidence: 99%

Antiviral efficacy of adefovir dipivoxil in the treatment of chronic hepatitis B subjects from Indian subcontinent

Ismail

Ramachandran

Kannangai

et al. 2014

Indian Journal of Medical Microbiology

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Adefovir is one of the therapeutic options for the treatment of chronic hepatitis B. A total of 30 adefovir-experienced subjects with the median treatment duration of 12 (interquartile range (IQR) 6-18) months were studied. Virological response was measured by hepatitis B virus deoxyribonucleic acid (HBV DNA) levels. HBV reverse transcriptase (rt) domains were sequenced for the identification of resistance mutations. Among the 30 subjects, two (7%) showed virological response and 19 (63%) were non-responders. The virological response for the remaining nine (30%) subjects was not determined. On sequence analysis, two subjects were identified with rtI169L and rtA181V mutation after 9 months and 18 months of adefovir treatment, respectively. Though the frequencies of adefovir resistance mutations are low, a large majority of subjects showed non-response. Therefore, adefovir in the management of HBV should be used judiciously.

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“…The detection limit for the ExiStation HBV diagnostic system using the WHO international standard was 9.55 IU/mL, which was lower than or similar to that of other real-time PCR systems (Artus-DB, 82 IU/mL; Artus-DSP, 9 IU/mL; Abbott, 1.43 IU/mL; Roche TaqMan, 12 IU/mL; new real-time PCR, 22.2 IU/mL) (Ismail et al, 2011;Caliendo et al, 2011;Chevaliez et al, 2010). The Bioneer ExiStation HBV diagnostic system was able to detect HBV DNA at a concentration lower than 10 IU/mL and meet the recommended Fig.…”

Section: Discussionmentioning

confidence: 65%

Performance evaluation of ExiStation HBV diagnostic system for hepatitis B virus DNA quantitation

Joο

Yoo

Sohn

et al. 2013

Journal of Virological Methods

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The performance of a recently developed real-time PCR system, the ExiStation HBV diagnostic system, for quantitation of hepatitis B virus (HBV) in human blood was evaluated. The detection limit, reproducibility, cross-reactivity, and interference were evaluated as measures of analytical performance. For the comparison study, 100 HBV-positive blood samples and 100 HBV-negative samples from Korean Blood Bank Serum were used, and the results of the ExiStation HBV system showed good correlation with those obtained using the Cobas TaqMan (r2=0.9931) and Abbott real-time PCR systems (r2=0.9894). The lower limit of detection was measured as 9.55 IU/mL using WHO standards and the dynamic range was linear from 6.68 to 6.68×10(9) IU/mL using cloned plasmids. The within-run coefficient of variation (CV) was 9.4%, 2.1%, and 1.1%, and the total CV was 11.8%, 3.6%, and 1.7% at a concentration of 1.92 log10 IU/mL, 3.88 log10 IU/mL, and 6.84 log10 IU/mL, respectively. No cross-reactivity or interference was detected. The ExiStation HBV diagnostic system showed satisfactory analytical sensitivity, excellent reproducibility, no cross-reactivity, no interference, and high agreement with the Cobas TaqMan and Abbott real-time PCR systems, and is therefore a useful tool for the detection and monitoring of HBV infection.

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Performance Characteristics and Comparison of Abbott and artus Real-Time Systems for Hepatitis B Virus DNA Quantification

Cited by 36 publications

References 10 publications

Clinical Relevance of Minimal Residual Viremia during Long-Term Therapy with Nucleos(t)ide Analogues in Patients with Chronic Hepatitis B

Clinical Relevance of Minimal Residual Viremia during Long-Term Therapy with Nucleos(t)ide Analogues in Patients with Chronic Hepatitis B

Antiviral efficacy of adefovir dipivoxil in the treatment of chronic hepatitis B subjects from Indian subcontinent

Performance evaluation of ExiStation HBV diagnostic system for hepatitis B virus DNA quantitation

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