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Evaluation of an automated system for the quantitation of human Herpesvirus-6 DNA from clinical specimens

BACKGROUND: Quantitation of human herpesvirus-6 (HHV-6) DNA in clinical specimens is important for the diagnosis and management of HHV-6-associated infection and reactivation in immunocompromised patients, particularly transplant recipients. METHODS: The analytical performance of the Altona RealStar...

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Autores principales: Mah, Jordan, Huang, ChunHong, Sahoo, Malaya K., Pinsky, Benjamin A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10462668/
https://www.ncbi.nlm.nih.gov/pubmed/37649537
http://dx.doi.org/10.1016/j.plabm.2023.e00329
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author Mah, Jordan
Huang, ChunHong
Sahoo, Malaya K.
Pinsky, Benjamin A.
author_facet Mah, Jordan
Huang, ChunHong
Sahoo, Malaya K.
Pinsky, Benjamin A.
author_sort Mah, Jordan
collection PubMed
description BACKGROUND: Quantitation of human herpesvirus-6 (HHV-6) DNA in clinical specimens is important for the diagnosis and management of HHV-6-associated infection and reactivation in immunocompromised patients, particularly transplant recipients. METHODS: The analytical performance of the Altona RealStar ASR HHV-6 qPCR on the semi-automated AltoStar AM16 system was assessed using HHV-6 reference material in plasma and cerebral spinal fluid (CSF). Qualitative and quantitative agreement was determined using 123 clinical EDTA plasma specimens tested using a laboratory-developed HHV-6 qPCR. RESULTS: The 95% Lower Limit of Detection was 20 IU/mL [95% confidence interval (CI): 10 to 29] in plasma and 78 IU/mL (95% CI: 55 to 146) in CSF. The assay was linear from 7.0 to 2.0 log(10) IU/mL in both matrices. Overall agreement of the RealStar ASR HHV-6 qPCR on the AltoStar AM16 with a laboratory-developed test was 95.9% (95% CI: 90.8 to 98.7). Passing-Bablok analysis of specimens quantifiable by both methods and at levels >1000 copies/mL revealed a regression line of Y = 1.00*X–0.20, with neither systematic (95% CI Y-intercept: −0.66 to 0.26) nor proportional (95% CI slope: 0.89 to 1.10) bias compared to the reference. CONCLUSIONS: The RealStar ASR HHV-6 qPCR on the AltoStar AM16 provides accurate quantitation for clinical monitoring of HHV-6 in immunocompromised hosts.
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spelling pubmed-104626682023-08-30 Evaluation of an automated system for the quantitation of human Herpesvirus-6 DNA from clinical specimens Mah, Jordan Huang, ChunHong Sahoo, Malaya K. Pinsky, Benjamin A. Pract Lab Med Original Research Article BACKGROUND: Quantitation of human herpesvirus-6 (HHV-6) DNA in clinical specimens is important for the diagnosis and management of HHV-6-associated infection and reactivation in immunocompromised patients, particularly transplant recipients. METHODS: The analytical performance of the Altona RealStar ASR HHV-6 qPCR on the semi-automated AltoStar AM16 system was assessed using HHV-6 reference material in plasma and cerebral spinal fluid (CSF). Qualitative and quantitative agreement was determined using 123 clinical EDTA plasma specimens tested using a laboratory-developed HHV-6 qPCR. RESULTS: The 95% Lower Limit of Detection was 20 IU/mL [95% confidence interval (CI): 10 to 29] in plasma and 78 IU/mL (95% CI: 55 to 146) in CSF. The assay was linear from 7.0 to 2.0 log(10) IU/mL in both matrices. Overall agreement of the RealStar ASR HHV-6 qPCR on the AltoStar AM16 with a laboratory-developed test was 95.9% (95% CI: 90.8 to 98.7). Passing-Bablok analysis of specimens quantifiable by both methods and at levels >1000 copies/mL revealed a regression line of Y = 1.00*X–0.20, with neither systematic (95% CI Y-intercept: −0.66 to 0.26) nor proportional (95% CI slope: 0.89 to 1.10) bias compared to the reference. CONCLUSIONS: The RealStar ASR HHV-6 qPCR on the AltoStar AM16 provides accurate quantitation for clinical monitoring of HHV-6 in immunocompromised hosts. Elsevier 2023-08-05 /pmc/articles/PMC10462668/ /pubmed/37649537 http://dx.doi.org/10.1016/j.plabm.2023.e00329 Text en © 2023 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Research Article
Mah, Jordan
Huang, ChunHong
Sahoo, Malaya K.
Pinsky, Benjamin A.
Evaluation of an automated system for the quantitation of human Herpesvirus-6 DNA from clinical specimens
title Evaluation of an automated system for the quantitation of human Herpesvirus-6 DNA from clinical specimens
title_full Evaluation of an automated system for the quantitation of human Herpesvirus-6 DNA from clinical specimens
title_fullStr Evaluation of an automated system for the quantitation of human Herpesvirus-6 DNA from clinical specimens
title_full_unstemmed Evaluation of an automated system for the quantitation of human Herpesvirus-6 DNA from clinical specimens
title_short Evaluation of an automated system for the quantitation of human Herpesvirus-6 DNA from clinical specimens
title_sort evaluation of an automated system for the quantitation of human herpesvirus-6 dna from clinical specimens
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10462668/
https://www.ncbi.nlm.nih.gov/pubmed/37649537
http://dx.doi.org/10.1016/j.plabm.2023.e00329
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