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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

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Název: 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
Autoři: Younhee Park, Juhye Roh, Sinyoung Kim
Přispěvatelé: Younhee Park, Juhye Roh, Sinyoung Kim, Kim, Sin Young
Zdroj: Ann Lab Med
Informace o vydavateli: Annals of Laboratory Medicine, 2022.
Rok vydání: 2022
Témata: 0301 basic medicine, Hepatitis B virus, Hepatitis C* / diagnosis, Performance, Hepacivirus, Sensitivity and Specificity, Agreement, cobas 6800 assay, 03 medical and health sciences, Humans, Viral load, Analytical sensitivity, 0303 health sciences, Aptima assay, Hepatitis C virus, HIV, Reproducibility of Results, Viral Load / methods, Viral Load, Hepatitis C, 3. Good health, HIV-1* / genetics, Viral / genetics, Molecular Diagnostic Techniques, HIV-1, RNA, RNA, Viral, Original Article, Hepatitis B virus / genetics, Hepacivirus / genetics
Popis: 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.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.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).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.
Druh dokumentu: Article
Other literature type
Jazyk: English
ISSN: 2234-3814
2234-3806
DOI: 10.3343/alm.2022.42.4.447
Přístupová URL adresa: https://www.annlabmed.org/journal/download_pdf.php?doi=10.3343/alm.2022.42.4.447
https://pubmed.ncbi.nlm.nih.gov/35177565
Rights: CC BY NC
CC BY NC ND
URL: http://creativecommons.org/licenses/by-nc/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0 (http://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Přístupové číslo: edsair.doi.dedup.....a19cc3ea944dd9d925991188a57a8136
Databáze: OpenAIRE
Popis
Abstrakt: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.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.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).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.
ISSN:22343814
22343806
DOI:10.3343/alm.2022.42.4.447