Performance Evaluation of the Aptima Assays in Comparison with the cobas 6800 Assays for the Detection of HIV-1, HBV, and HCV in Clinical Samples
0
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
Background: Accurate and consistent viral load (VL) quantitation of HIV type 1 (HIV-1), hepatitis B virus (HBV), and hepatitis C virus (HCV) is important for diagnosis and clinical monitoring. Assay results have to be concordant and compatible across laboratories. We evaluated the performance of three Aptima assays (Hologic, San Diego, CA, USA) and compared their VL values with corresponding cobas 6800 assay (Roche Diagnostics, Mannheim, Germany) results, using 840 clinical samples. Methods: The correlation between VL results obtained using the two assays was evaluated in terms of analytical sensitivity, precision/reproducibility, linearity, and cross-reactivity. Agreement rates were determined using kappa statistics. The overall agreement of VL values was examined using Passing–Bablok regression analysis. Results: All CVs were within 5%; the assays had good precision for detecting all three viruses. The linearity of quantitation assessed using three AccuSpan linearity panels (Seracare, Milford, MA, USA), was excellent for the Aptima assays. For HIV-1 and HCV, the results of both assays showed excellent agreement (κ=0.89 and 0.90, respectively) while for HBV, the results showed good agreement (κ=0.69). For analytical sensitivity, the VLs required for a 100% detection rate of HIV-1, HBV, and HCV were 20 copies/mL, 7.5 IU/mL, and 5.0 IU/mL, respectively. The results for HIV-1, HBV, and HCV obtained using both assays correlated strongly (R2=0.97, 0.93, and 0.95, respectively). Conclusions: The cobas 6800 and Aptima assays, with fully automated and high-throughput molecular platforms for HIV-1, HBV, and HCV VL measurements, show good analytical performance and a strong correlation between results. The study results suggest that the assays can be used interchangeably for long-term monitoring of chronic infections.
Abstract
Background: Accurate and consistent viral load (VL) quantitation of HIV type 1 (HIV-1), hepatitis B virus (HBV), and hepatitis C virus (HCV) is important for diagnosis and clinical monitoring. Assay results have to be concordant and compatible across laboratories. We evaluated the performance of three Aptima assays (Hologic, San Diego, CA, USA) and compared their VL values with corresponding cobas 6800 assay (Roche Diagnostics, Mannheim, Germany) results, using 840 clinical samples. Methods: The correlation between VL results obtained using the two assays was evaluated in terms of analytical sensitivity, precision/reproducibility, linearity, and cross-reactivity. Agreement rates were determined using kappa statistics. The overall agreement of VL values was examined using Passing–Bablok regression analysis. Results: All CVs were within 5%; the assays had good precision for detecting all three viruses. The linearity of quantitation assessed using three AccuSpan linearity panels (Seracare, Milford, MA, USA), was excellent for the Aptima assays. For HIV-1 and HCV, the results of both assays showed excellent agreement (κ=0.89 and 0.90, respectively) while for HBV, the results showed good agreement (κ=0.69). For analytical sensitivity, the VLs required for a 100% detection rate of HIV-1, HBV, and HCV were 20 copies/mL, 7.5 IU/mL, and 5.0 IU/mL, respectively. The results for HIV-1, HBV, and HCV obtained using both assays correlated strongly (R2=0.97, 0.93, and 0.95, respectively). Conclusions: The cobas 6800 and Aptima assays, with fully automated and high-throughput molecular platforms for HIV-1, HBV, and HCV VL measurements, show good analytical performance and a strong correlation between results. The study results suggest that the assays can be used interchangeably for long-term monitoring of chronic infections.
참고문헌 (35)
- "Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach, 2nd ed" (2016)[URL]
- AASLD, "IDSA HCV Guidance Panel", Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus, 2015, pp.62, 932~954
- European Association for the Study of the Liver, "EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection", J Hepatol, 67, pp.370~398 (2017)
- European Association for the Study of the Liver, "EASL Recommendations on Treatment of Hepatitis C 2018", J Hepatol, 69, pp.461~511 (2018)
- European Association for the Study of the Liver, "EASL recommendations on treatment of hepatitis C : final update of the series☆", J Hepatol, 73, pp.1170~1218 (2020)
- Ryom L, "Highlights of the 2017 European AIDS Clinical Society (EACS) Guidelines for the treatment of adult HIV-positive persons version 9.0", HIV Med, 19, pp.309~315 (2018)
- Terrault NA, "AASLD guidelines for treatment of chronic hepatitis B", Hepatology, 63, pp.261~283 (2016)
- Terrault NA, "Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance", Hepatology, 67, pp.1560~1599 (2018)
- Aretzweiler G, "Analytical performance of four molecular platforms used for HIV-1, HBV and HCV viral load determinations", Expert Rev Mol Diagn, 19, pp.941~949 (2019)
- Günthard HF, "Antiretroviral treatment of adult HIV infection : 2014 recommendations of the International Antiviral Society-USA Panel", Jama, 312, pp.410~425 (2014)
- Wiesmann F, "Multicenter evaluation of two next-generation HIV-1 quantitation assays, Aptima Quant Dx and cobas 6800, in comparison to the RealTime HIV-1 reference assay", J Clin Microbiol, 56 (2018)
- Wiesmann F, "Variation analysis of six HCV viral load assays using low viremic HCV samples in the range of the clinical decision points for HCV protease inhibitors", Med Microbiol Immunol, 204, pp.515~525 (2015)
- Hayden RT, "Progress in quantitative viral load testing : variability and impact of the WHO quantitative international standards", J Clin Microbiol, 55, pp.423~430 (2017)
- Schalasta G, "Performance of the new Aptima HCV Quant Dx assay in comparison to the Cobas TaqMan HCV2 test for use with the high pure system in detection and quantification of hepatitis C virus RNA in plasma or serum", J Clin Microbiol, 54, pp.1101~1107 (2016)
- Manak MM, "Evaluation of Hologic Aptima HIV-1 Quant Dx assay on the Panther system on HIV subtypes", J Clin Microbiol, 54, pp.2575~2581 (2016)
- Nair SV, "Aptima HIV-1 Quant Dx—A fully automated assay for both diagnosis and quantification of HIV-1", J Clin Virol, 77, pp.46~54 (2016)
- Sauné K, "Detection and quantification of HIV-1 RNA with a fully automated transcription-mediated-amplification assay", J Clin Virol, 84, pp.70~73 (2016)
- Schalasta G, "Comparative evaluation of the Aptima HIV-1 Quant Dx assay and COBAS TaqMan HIV-1 v2.0 assay using the Roche High Pure System for the quantification of HIV-1 RNA in plasma", Clin Chem Lab Med, 54, pp.493~499 (2016)
- Tabrizi SN, "Evaluation of the Hologic Panther transcription-mediated amplification assay for detection of Mycoplasma genitalium", J Clin Microbiol, 54, pp.2201~2203 (2016)
- Chevaliez S, "The new Aptima HBV Quant Real-Time TMA assay accurately quantifies hepatitis B virus DNA from genotypes A to F", J Clin Microbiol, 55, pp.1211~1219 (2017)
- Chevaliez S, "The new Aptima HCV Quant Dx Real-time TMA assay accurately quantifies hepatitis C virus genotype 1-6 RNA", J Clin Virol, 91, pp.5~11 (2017)
- Schønning K, "Comparison of the Hologic Aptima HIV-1 Quant Dx assay to the Roche COBAS Ampliprep", COBAS TaqMan HIV-1 test v2.0 for the quantification of HIV-1 RNA in plasma samples, 2017, pp.92, 14~19
- Schønning K, "Analytical and clinical performance of the Hologic Aptima HCV Quant Dx assay for the quantification of HCV RNA in plasma samples", J Virol Methods, 248, pp.159~165 (2017)
- Worlock A, "Analytical characteristics and comparative evaluation of Aptima HCV Quant Dx assay with the Abbott RealTime HCV assay and Roche COBAS AmpliPrep", COBAS TaqMan HCV quantitative test v2.0, 2017, pp.14, 66~
- Longo S, "Comparison of the Aptima HIV-1 Quant Dx assay with the COBAS AmpliPrep", COBAS TaqMan HIV-1 v2.0 test for HIV-1 viral load quantification in plasma samples from HIV-1-infected patients, 2018, pp.1, e31~
- May S, "Evaluating the aptima HIV-1 quant Dx, HCV quant Dx and HBV quant assays against the Abbott HIV-1, HCV and HBV RealTime assays", J Clin Virol, 106, pp.7~10 (2018)
- Schalasta G, "Evaluation of the Aptima HBV Quant assay vs. the COBAS TaqMan HBV test using the high pure system for the quantitation of HBV DNA in plasma and serum samples", Clin Chem Lab Med, 56, pp.634~641 (2018)
- Schønning K, "Analytical performance of the Hologic Aptima HBV Quant assay and the COBAS Ampliprep", COBAS TaqMan HBV test v2.0 for the quantification of HBV DNA in plasma samples, 2018, pp.104, 83~88
- Mwau M, "Performance evaluation of the Aptima HIV-1 Quant Dx assay for detection of HIV in infants in Kenya", J Clin Virol, 125, pp.104289~ (2020)
- Rossetti R, "Performance evaluation of the Aptima HIV-1 RNA Quant assay on the Panther system using the standard and dilution protocols", J Clin Virol, 129, pp.104479~ (2020)
- Aretzweiler G, "Generating timely molecular diagnostic test results : workflow comparison of the cobas® 6800", 8800 to Panther, 2019, pp.19, 951~957
- Maasoumy Bz, "HBV-RNA co-amplification may influence HBV DNA viral load determination", Hepatol Commun, 4, pp.983~997 (2020)
- CLSI, "Evaluation of precision of quantitative measurement procedure; approved guideline" (2014), Clinical Laboratory Standards Institute
- CLSI, "Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline" (2003), Clinical and Laboratory Standards Institute
- "Stanford University HIV Drug Resistance Database. HIVdb version 9.0" (2021)[URL]