Cost minimization analysis of an in-house molecular test for cytomegalovirus in relation to a commercial molecular system
| Autor: | Izadora Clezar da S. Vasconcellos, Franciéli Pedrotti Rozales, Ana Paula Alegretti, Roger Kist, Maikel Reck-Kortmann, Cassia Ferreira B. Caurio, Alessandro C. Pasqualotto, Daiane F. Dalla Lana, Giácomo Balbinotto Neto, Odelta dos Santos Allende |
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| Rok vydání: | 2019 |
| Předmět: |
Microbiology (medical)
lcsh:QR1-502 Congenital cytomegalovirus infection Severe disease Cytomegalovirus Computational biology medicine.disease_cause Real-Time Polymerase Chain Reaction Sensitivity and Specificity lcsh:Microbiology World health lcsh:Infectious and parasitic diseases 03 medical and health sciences 1st WHO International Standard for Human Cytomegalovirus Medicine Humans lcsh:RC109-216 0303 health sciences 030306 microbiology business.industry Reproducibility of Results Viral Load medicine.disease Standardization BK virus Cytomegalovirus infection qPCR Infectious Diseases Real-time polymerase chain reaction Cost-minimization analysis Cytomegalovirus Infections DNA Viral Cost analysis Costs and Cost Analysis In-house assay Reagent Kits Diagnostic business |
| Zdroj: | Brazilian Journal of Infectious Diseases v.24 n.3 2020 Brazilian Journal of Infectious Diseases Brazilian Society of Infectious Diseases (BSID) instacron:BSID Brazilian Journal of Infectious Diseases, Vol 24, Iss 3, Pp 191-200 (2020) |
| ISSN: | 1678-4391 |
| Popis: | Introduction Cytomegalovirus may cause severe disease in immunocompromised patients. Nowadays, quantitative polymerase chain reaction is the gold-standard for both diagnosis and monitoring of cytomegalovirus infection. Most of these assays use cytomegalovirus automated molecular kits which are expensive and therefore not an option for small laboratories, particularly in the developing world. Objective This study aimed to optimize and validate an in-house cytomegalovirus quantitative polymerase chain reaction test calibrated using the World Health Organization Standards, and to perform a cost-minimization analysis, in comparison to a commercial cytomegalovirus quantitative polymerase chain reaction test. Study design 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 cytomegalovirus tested with m2000 RealTime System (Abbott Laboratories, BR) were tested with the in-house assay, as well as patients infected with 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. Results The in-house assay had a limit of detection and quantification of 60.3 IU/mL, with no cross-reactivity with the other viral agents tested. Moreover, the test was precise and had a R2 of 0.954 when compared with the m2000 equipment. The cost analysis showed that the assay was economically advantageous costing a median value of 37.8% and 82.2% in comparison to the molecular test in use at the hospital and the m2000 equipment, respectively. Conclusions These results demonstrated that in-house quantitative polymerase chain reaction testing is an attractive alternative in comparison to automated molecular platforms, being considerably less expensive and as efficacious as the commercial methods. |
| Databáze: | OpenAIRE |
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