Evaluation of a human adenovirus viral load assay using the Altona RealStar® PCR test

Publication date: Available online 2 December 2017
Source:Diagnostic Microbiology and Infectious Disease
Author(s): Hanna Rennert, Girish Ramrattan, Zhengming Chen, Patrick McIntire, Alber Michaeel, Anna Khazanova, Stephen G. Jenkins, John Sipley
This study evaluated the performance of the Altona Diagnostics RealStar® Adenovirus Research Use Only (RUO) real-time PCR reagents for HAdV quantitation in plasma samples from immunodeficient patients. The assay was linear from 2.30–9.17 log10 copies/mL (coefficient of determination; R²=0.998) with limits of detection and quantification of 2.19 log10 and 2.30 log10 copies/mL (>95% positivity rate), respectively. Assay precision was highly reproducible with coefficients of variance ranging from 0% to 4.7%. A comparison of 66 matched samples showed good agreement (R²=0.845) between the Altona and the reference laboratory assay, with an average negative bias (−0.24 log10 copies/mL). Genotyping analysis demonstrated that HAdV species B and C accounted for 77% of the positive samples. A significant (≥0.9 log10) difference in quantitation between both tests was found for three HAdV types (HAdV types A12, B14 and F41). In conclusion, the Altona RealStar® test is a reliable and sensitive assay for HAdV DNA quantitation.



from ! ORL Sfakianakis via paythelady.61 on Inoreader http://ift.tt/2iGwumx
via IFTTT