Objectives: To estimate the direct cost components of pulmonary arterial hypertension (PAH) in a Turkish setting. MethOds: Delphi-technique was used. An expert-panel consisting of members from cardiology, pulmonology and cardiovascular surgery met to discuss the disease management processes in PAH. The global and local-literature and guidelines have been reviewed and local clinical practices questionnaires (separately for functional classes (FC)) have been completed. All costcomponents, including medications, surgical treatment, hospitalization, screening and outpatient follow-up procedures were reviewed. February-2016 local prices released by Ministry of Health and Social Security Institution in Turkey were used as references. February-2016 currency rate was used. Results: The total-costs, excluding disease-specific medications, of PAH/year for patients in FC-II, FC-III and FC-IV were calculated as 576€ , 1,005€ and 5,542€ , respectively. The corresponding costs of disease-specific medications were 8,864€ , 17,920€ and 17,920€ (panel experts noted that disease-specific drugs are given in similar combinations and doses in FC-III and FC-IV). Therefore, the total annual-costs of PAH in FC-II, FC-III and FC-IV were estimated as 9,440€ , 18,925€ and 23,462€ , respectively. Costs of other components per annum, used in calculating the total-cost in FC-II, FC-III and FC-IV were as follows: follow-up: 101€ , 199€ and 1,355€ ; medications for palliation: 116€ , 156€ and 1,867€ ; non-pharmacologic treatment: 126€ , 366€ and 366€ ; laboratory tests: 232€ , 283€ and 1,211€ , respectively. Cost of lung-transplantation was found as 742€ in FC-IV (percentage of FC-IV patients assumed to be transplanted "lung" and "heart-lung" is 2.5% and 0.1%, respectively and price of each operation is 28,550€ [28,550x2.5%+28,5 50x0.1%= 742€ ]). cOnclusiOns: The main driver of direct cost components in PAH is the cost of disease-specific drugs. The total direct cost components increase when the functional class of the patients progresses from FC-II to FC-IV. Consequently, improving diagnosis rate and ensuring to start appropriate treatment in early stages in PAH patients may help to decrease the costs of treatment. PCV58
Background: The duration of the vaccine's protective efficacy against SARS-CoV-2 is unknown. Evaluation of the clinical performance of available tests is required. Objectives: To evaluate the clinical performance of three immunoassays for the detection of IgG antibodies generated by mRNA vaccines against SARS-CoV-2. Methods: Two automated immunoassays (Euroimmun Anti-SARS-CoV-2 ELISA IgG and Abbott SARS-CoV-2 CLIA IgG) and one lateral flow immunoassay (LFIA Test Livzon IgG) were tested. 300 samples distributed in 3 groups were analyzed: 100 subjects over 18 years old and under 45 years old, 100 subjects between 45-65 years old and another 100 over 65 years old. collected before vaccination, at 21 days, 1, 2, 3 and 6 months post-vaccination. Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, and agreement (I. Kappa) were calculated for each serological test. Results: Maximum sensitivity for IgG was 98.7%, 98.1%, and 97.8% for the ELISA Euroimmun, CLIA Abbott, and Livzon LFIA assays and maximum specificity for IgG was 99.4%, 99.9%. % and 98.4% ELISA, CLIA and LFIA respectively at 3 months after vaccination with a decrease in antibody levels from the sixth month. The best agreement was observed between ELISA and CLIA 100%; (k = 1.00). The agreement between ELIA, CLIA and LIFIA was 99% (k = 0964) at the second and third month after vaccination. Seroconversion was faster and longer lasting in the younger age groups. Conclusion: Our study showed an equivalent and homogeneous clinical performance for IgG of three immunoassays after vaccination and that the LIFIA assay is the most cost-effective, reliable and accurate for routine use in population studies of seroconversion and seroprevalence.
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