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...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-08-01
|
| Series: | Practical Laboratory Medicine |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352551723000239 |
| _version_ | 1797692797820600320 |
|---|---|
| author | Jordan Mah ChunHong Huang Malaya K. Sahoo Benjamin A. Pinsky |
| author_facet | Jordan Mah ChunHong Huang Malaya K. Sahoo Benjamin A. Pinsky |
| author_sort | Jordan Mah |
| collection | DOAJ |
| 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 log10 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. |
| first_indexed | 2024-03-12T02:33:44Z |
| format | Article |
| id | doaj.art-5ff84fa8a3ff4c46a3c43323892ecf40 |
| institution | Directory Open Access Journal |
| issn | 2352-5517 |
| language | English |
| last_indexed | 2024-03-12T02:33:44Z |
| publishDate | 2023-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Practical Laboratory Medicine |
| spelling | doaj.art-5ff84fa8a3ff4c46a3c43323892ecf402023-09-05T04:16:00ZengElsevierPractical Laboratory Medicine2352-55172023-08-0136e00329Evaluation of an automated system for the quantitation of human Herpesvirus-6 DNA from clinical specimensJordan Mah0ChunHong Huang1Malaya K. Sahoo2Benjamin A. Pinsky3Department of Pathology, Stanford University School of Medicine, Stanford, CA, USADepartment of Pathology, Stanford University School of Medicine, Stanford, CA, USADepartment of Pathology, Stanford University School of Medicine, Stanford, CA, USADepartment of Pathology, Stanford University School of Medicine, Stanford, CA, USA; Department of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, CA, USA; Corresponding author. 3375 Hillview, Room 2913 Palo Alto, CA 94304, USA.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 log10 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.http://www.sciencedirect.com/science/article/pii/S2352551723000239 |
| spellingShingle | Jordan Mah ChunHong Huang Malaya K. Sahoo Benjamin A. Pinsky Evaluation of an automated system for the quantitation of human Herpesvirus-6 DNA from clinical specimens Practical Laboratory Medicine |
| 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 |
| url | http://www.sciencedirect.com/science/article/pii/S2352551723000239 |
| work_keys_str_mv | AT jordanmah evaluationofanautomatedsystemforthequantitationofhumanherpesvirus6dnafromclinicalspecimens AT chunhonghuang evaluationofanautomatedsystemforthequantitationofhumanherpesvirus6dnafromclinicalspecimens AT malayaksahoo evaluationofanautomatedsystemforthequantitationofhumanherpesvirus6dnafromclinicalspecimens AT benjaminapinsky evaluationofanautomatedsystemforthequantitationofhumanherpesvirus6dnafromclinicalspecimens |