Cytomegalovirus (CMV) causes severe diseases in the immunocompromised patients. Nowadays, quantitative polymerase chain reaction (qPCR) is the gold-standard for diagnosis and monitoring of CMV infection. Most of the studies use CMV automated molecular assays which are expensive and, therefore, not an option for small laboratories, particularly in the developing world.
This study aimed to optimize and validate an in-house CMV qPCR test calibrated using the World Health Organization Standard, and to perform a cost-minimization analysis, in comparison to commercial CMV qPCR tests.
The methodology consisted of determining: optimization, analytical sensitivity, analytical specificity, precision, curve variability analysis, and inter-laboratorial reproducibility. Patients (n=30) with known results for CMV tested with m2000 RealTime System (Abbott Laboratories, BR) were tested with the in-house assay, as well as patients with known infection for several other human herpes virus, in addition to BK virus. A cost-minimization analysis was performed, from a perspective of the laboratory, assuming diagnostic equivalence of the methodologies applied in the study.
The results showed that the in-house assay had a limit of detection and quantification of 60.26IU/mL, with no cross-reactivity with the other viral agents. Moreover, the test was precise and had a R of 0.954 when compared with m2000 equipment. The cost analysis showed that the assay was very economically advantageous with median of 37.8% (range 9.3-40.7%) and 82.2% (range 82.2-82.3%) than the test used in the hospital and the m2000 equipment respectively.
These results demonstrated that in-house qPCR testing is a possible alternative in comparison to automated platforms, being considerably less expensive and as efficacious as the commercial methods.
Copyright © 2020. Published by Elsevier España, S.L.U.