ABSTRACT
【Objective】 To compare the analytical performance of Tigris, Panther, ChiTaS BSS1200 and cobas S201 system to see if they satisfy the requirements of blood screening and to know the concordance of the results presented by these four systems. 【Methods】 According to the relevant documents of ISO15189 and Standard Operating Procedure of Blood Station(2019), the parameters needed to be verified for nucleic acid tests(NAT) included: analytical sensitivity verification, system compare test, anti-jamming capability and anti-cross-contamination ability. 【Results】 The 95% detection limits of Tigris, Panther, ChiTaS BSS1200 and Cobas S201 for HBV-DNA(IU/mL), HIV-RNA(IU/mL) and HCV-RNA(IU/mL) were 2.013 vs 4 vs 2.995 vs 0.99, 13.039 vs 10.21 vs 30.952 vs 32.24, and 2.278 vs 2.077 vs 12.008 vs 3.39, respectively. In the performance comparison verification between NAT systems, the results of the two sets of Tigris systems were in full accordance with serum plate, with a concordance rate of 100%, Kappa value of 1, and none cross-contamination.The concordance rate of No.1 Panther system was 100%, and No.2 98%, with Kappa value of 0.961 and none cross-contamination. Hemolytic samples (5g/L Hb concentration) and lipemic blood samples (13.81 mmol/L TG concentration) had no significant effect on the detection of low-concentration samples. 【Conclusion】 No significant differences in the performance of NAT systems were notable by devices, as the four systems were fully automated with high sensitivity, which can fully satisfy the blood screening requirements. Panther system demonstrates superior analysis sensitivity in HCV-RNA/HIV-RNA and lower in HBV DNA, but also in required criteria, as compared to Tigris system. Neither hemolysis nor lipemic blood had any significant effect on the test results.
ABSTRACT
Objective To evaluate the health related quality of life (HRQoL) and to explore the influencing factors related to the prevalence of the essential hypertension,diabetes,coronary heart disease (CHD) and stroke in middle-aged and elderly people from rural communities.Methods A total of 5345 individuals were chosen from a 2010 Health Survey in Fangshan,Beijing.Self-designed questionnaire was applied to collect the information on general health-related behaviors,chronic conditions,self-rated health,blood pressure and HRQoL with the EuroQoL questionnaire (EQ-5D) were measured.Probit regression model was used to identify the influencing factors on HRQoL,adjusting age,marriage status,education level,smoking,alcohol intake,physical activity and control of blood pressure.Population Attributable Risk Proportion (PARP) for estimating the influence of chronic disease on HRQoL was also calculated.Results The average EQ-5D index was 0.923 ±0.145,with 72.1％ of the overall respondents in the status of having chronic diseases.Participants with chronic diseases had significantly lower EQ-5D index (0.907 ± 0.155 ) than those without (0.963 ±0.105 ) (t =15.082,P＜ 0.001 ).Significant relations were found between a lower HRQoL and chronic diseases.Relative risk (RR) and 95％ confidence interval (95％ CI) of poor HRQoL in populations with hypertension,diabetes,CHD and stroke were 1.686 (95％CI: 1.519-1.871),1.725 (95％CI:1.502-1.981 ),1.869 (95％CI: 1.663-2.099),and 1.759 (95％CI: 1.474-2.089) respectively.The most influential disease appeared to be stroke in male (RR=1.929,95％CI: 1.462-2.546),whereas CHD in female individuals (RR=1.926,95％CI: 1.671-2.220).Rates of PARP (PAR％) for poor HRQoL in chronic disease subgroups were as follow: hypertension 31.05％,CHD 23.39％,diabetes 4.84％ and stroke 4.44％,respectively.Conclusion This study suggested that stroke,at individual level,was the major influential factor to HRQoL.However,hypertension remained the leading preventable influential factor to HRQoL at the population level.