Performance Evaluation of the Beckman Coulter DxN VERIS Hepatitis B Virus (HBV) Assay in Comparison With the Abbott RealTime HBV Assay

Park, Joonhong; Cho, Hanwool; Choi, Seung Jun; Lee, Gun Dong; Sin, Sang Hyun; Ryu, Ji Hyeong; Park, Hye Sun; Lee, Hyeyoung; Kim, Yonggoo; Oh, Eun‐Jee

doi:10.3343/alm.2019.39.1.86

Cited by 5 publications

(3 citation statements)

References 16 publications

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“…VL measurements may be performed at different laboratories during long-term disease management, and variable assay performance may hamper the concordance and commutability of results and may lead to inappropriate treatment [26][27][28][29][30]. Commonly used VL tests include those manufactured by Roche (cobas 6800/8800; c6800) and cobas 4800 (c4800) systems [29,[31][32][33], Abbott (m2000 RealTime) [34,35], Hologic (Aptima, Panther) [36][37][38][39][40], Beckman (VERIS) [41][42][43][44][45][46][47][48] and others. Most of these assays rely on quantitative, real-time RT-PCR, while the Aptima assay uses transcription-mediated amplification (TMA), which may impart some differences in performance characteristics.…”

Section: Introductionmentioning

confidence: 99%

Analytical performance of four molecular platforms used for HIV-1, HBV and HCV viral load determinations

Aretzweiler

Leuchter

García–Álvarez

et al. 2019

Expert Review of Molecular Diagnostics

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Background: Viral load (VL) quantification is important for the management of HBV, HCV, and HIV-1-infected patients. Several semi-or fully automated systems and assays are available that can be used to measure VL for these and other targets. Research design and methods: We assessed the accuracy, genotype/subtype inclusivity, and precision of four VL assays for three viral targets: cobas 4800 (Roche), cobas 6800 (Roche), Aptima (Hologic) and VERIS (Beckman), using WHO standards, cell culture supernatants and clinical samples. Results: Most results were close to expected values, except for significant under-quantification of HIV-1 group O, HBV genotype C, and D at high VL, and HCV genotype 3 by Aptima, and of HIV-1 CRF01_AE and group N and HCV genotype 3 by VERIS. Precision was comparable between tests except for VERIS HCV, which showed more variability. Aptima and cobas 6800 results agreed well with each other except HBV VL at lower VL (<10,000 IU/mL) where Aptima results tended to be higher. Conclusions: Results from different VL assays may not always agree in certain subsets of patients. Clinicians should we aware of these findings when making treatment decisions.

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Section: Introductionmentioning

confidence: 99%

Analytical performance of four molecular platforms used for HIV-1, HBV and HCV viral load determinations

Aretzweiler

Leuchter

García–Álvarez

et al. 2019

Expert Review of Molecular Diagnostics

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“…A limitation of our study is that different HBV genotypes were not tested on HBV DNA quantification. Most HBV genotypes in Korea are genotype C2 or a mixed pattern of genotypes B and C, and other genotypes rarely occur [8,9].…”

Section: Discussionmentioning

confidence: 99%

Performance Evaluations of the Abbott Alinity m Assay in Comparison with the Abbott m2000 Assay for Hepatitis B and Hepatitis C Viruses

et al. 2020

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Background: The quantification of the hepatitis B virus (HBV) or hepatitis C virus (HCV) is critical for the diagnosis and prognostic follow-up of the viral infection. The Alinity m assay is a recently developed, fully automated "random-access" system for quantitative molecular assays. The aim of this study was to verify the validity of the Alinity m assay by comparing its performance in HBV and HCV quantifications with the established Abbott m2000 HBV and HCV assays. Methods: The precision, linearity, limit of detection (LOD), correlation with the Abbott m2000 assay, and interference were evaluated. Results: The within-laboratory standard deviation ranged from 0.106 to 0.137 log IU/mL for HBV and from 0.073 to 0.097 log IU/mL for HCV, which was lower than the manufacturer's specification of 0.25 log IU/mL, indicating good precision. Linearity was observed from 1.14 to 8.14 log IU/mL for the HBV assay and from 1.09 to 7.09 log IU/mL for the HCV assay. The LODs of HBV and HCV were 10 and 6.39 IU/mL, respectively, which were equivalent to or better than those claimed by the manufacturer. For comparative evaluation between Alinity m and m2000 assays, 142 HBV and 70 HCV samples were tested. The correlation test revealed a strong correlation for both markers, and the Passing-Bablok regression analysis did not reveal any significant deviation. Conclusions: The Alinity m assay demonstrated excellent performance for HBV and HCV quantifications with reduced hands-on time and a randomaccess format.

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“…According to WHO guidelines on hepatitis B and C testing, HBV DNA is measured in international units (IU/mL) as the recognized international standard [23]. However, a logarithmic transformation of original data is commonly preferred in method comparison studies to obtain a better distribution of the differences [24][25][26][27]. Thus, HBV DNA measurements in IU/mL were transformed to log values in the current study to assess the agreement and the correlation of data.…”

Section: Discussionmentioning

confidence: 99%

NeuMoDx random access molecular diagnostic system for detection and quantification of hepatitis B virus in clinical samples

Arıkan

Sayan

Doluca

2020

J Infect Dev Ctries

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Introduction: Currently, several molecular assays are available to detect and quantify HBV DNA in clinical samples. We aimed to characterize and compare the clinical performance of newly designed NeuMoDx PCR to the existing artus PCR. Methodology: The plasma HBV DNA levels of 96 clinical and 5 external quality control samples were measured by NeuMoDx and artus assays simultaneously in Kocaeli University, Turkey. The linearity, agreement and the correlation between two assays were determined by Deming regression analysis, Bland-Altman plotting, the chi-square and the relative absolute error statistical analyzes. For all statistical analyzes, the XLSTAT statistical program was used. Results: The mean (standard deviation; SD) age was 45.07 ± 12.29. HBsAg S/Co median (range) was 4,273.4 ± 1,138.1 and ALT U/L median (range) was 27 ± 16. The mean (SD) of HBV DNA was 1.46+E6 ± 1.0+E4 for NeuMoDx and 1.54+E5 ± 4.7 + E4 for artus assays. The Deming regression indicates a linear correlation (95% confidence). The chi-square test indicates strong correlation (p < 0.001). Bland-Altman analysis confirms that the measurement difference is acceptable. The relative absolute error analysis for artus showed relatively less and more consistent error rate. With 5 external quality check samples, the statistical significance was low (p = 0.566). Conclusions: The NeuMoDx HBV assay showed an excellent analytical performance by providing a rapid, high throughput technology in a random-access testing system in clinical samples and may be a new solution for viral load quantification in the management of HBV infections.

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Performance Evaluation of the Beckman Coulter DxN VERIS Hepatitis B Virus (HBV) Assay in Comparison With the Abbott RealTime HBV Assay

Cited by 5 publications

References 16 publications

Analytical performance of four molecular platforms used for HIV-1, HBV and HCV viral load determinations

Analytical performance of four molecular platforms used for HIV-1, HBV and HCV viral load determinations

Performance Evaluations of the Abbott Alinity m Assay in Comparison with the Abbott m2000 Assay for Hepatitis B and Hepatitis C Viruses

NeuMoDx random access molecular diagnostic system for detection and quantification of hepatitis B virus in clinical samples

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