ABSTRACT
Objective To establish and assess the new method of APTT assay based on the combinations of Mg2+and Ca2+for lupus anticoagulants(LA)measurements.Methods This prospective study included 309 trisodium citrate anticoagulated plasma samples from 244 random patients and 65 patients with different autoimmune diseases(AID)to establish and assess the method of LA measurement, respectively.Final concentrations of 0,2.0, 4.0, 8.0,16.0 mmol/L Mg2+were added into 25 mmol/L Ca2+solution, and Actin reagent was used to measured plasma APTT of 94 patients.The applied concentration of Mg2+-Ca2+solution was confirmed through the special and significant alteration of APTT from LA-positive and -negative plasma observed in the presence of Mg 2+(test solution).Based on Actin reagent use,the test solution and 25 mmol/L Ca2+solution were applied to measure APTT of patients and normal individuals, respectively, and the ratio of Mg2+-Ca2+-APTT to Ca2+-APTT(Mg2+-Ca2+-APTT indices)and normalized Mg2+-Ca2+-APTT indices(NAR)were calculated, respectively.Mixed plasma NAR was measured,and CV%was calculated to evaluate the repeatability and stability of Mg 2+-Ca2+-APTT method.APTT of 150 patients was measured with the test solution and Actin reagent to calculate Mg 2+-Ca2+-APTT indices, and normalized LA ratio was determined with dRVVT method.The applicability of Mg2+-Ca2+-APTT assay was assessed through comparisons of the results from the two methods.Finally, NAR and NLR of 65 patients with AID(including 26 SLE patients)were measured with Mg2+-Ca2+-APTT assay and dRVVT method, respectively, and ROC curve was also used to assess the efficacy of the two methods for LA measurements.Results In all LA-negative plasma,APTT increased from 28.1 ±4.5 s to 61.2 ±7.9 s in normal APTT group,47.2 ±8.9 s to 97.5 ±10.3 s in increased APTT group,and 27.6 ± 5.1 s to 61.2 ±7.9 s in ACA-positive group when Mg2+increased from 0 to 8 mmol/L in Mg2+-Ca2+solution(F=34.12, 38.9 and 28.35,P<0.01).Following increased Mg2+concentration, APTT shortened from 0 to 4.0 mmol/L, but simultaneously prolonged from 4.0 to 16.0 mmol/L in LA-positive plasma with prolonged or normal APTT(F=31.55 and 39.51, P<0.01), and APTT was significantly higher in 8.0 mmol/L than that in 4.0 mmol/L(P<0.001).The test concentration of Mg 2+/Ca2+solution was 4.0 mmol/L.The within, inter-day CV% of NAR was 1.39%,2.30%, and 3.44%, respectively. According to the judging criteria of <0.966 and >1.034 of Mg2+/Ca2+indices, there was 141 patients with increased indices and NLR <1.20, and 9 patients with decreased ones and NLR≥1.20 in all 150 patients.The area under ROC curve of NAR and NLR for LA detection was 0.913(95%CI:0.848-0.978) and 0.892(95%CI:0.817-0.966), respectively, and the cut-off value was 0.87 and 1.13, respectively. The sensitivity and specificity of NAR(85% and 77%)was higher than that of NLR(81% and 74%), respectively.The accordant rate of positive,negative,and total results between NAR and NLR was 94.4%, 98.5%,and 98%,respectively.Conclusion The method of APTT assay based on Mg2+combining Ca2+for LA measurements is feasible,and can be used to detect plasma LA of patients.
ABSTRACT
Objective@#To evaluate analytical performance and clinical application value of a one-step HBV DNA quantitative detecting system.@*Methods@#Analytical performance of the one-step HBV DNA quantitative detecting reagents included precision, residual contamination, accuracy, functional sensitivity and analytical measurement range were verified by collecting high concentration samples and external quality control samples from Jiangsu provincial clinical test center.@*Results@#The within-run coefficient of variation (CV) of both low and high concentration samples were below 5%, meanwhile the intra-assay CV was below 3/5 TEa and inter-assay CV was below 4/5 TEa. There was no residual contamination and the analytic accuracy met the requirement of external quality assessment (EQA). Functional sensitivity was able to attain 100 IU/ml, while the day to day CV was below 20%. It exhibited a benign linear relation from 7.58×101 to 7.58×108 IU/ml.@*Conclusions@#The analytic performance of a new testing system must be evaluated particularly before detecting samples of patients by quantitative tests. This study proves that the one-step HBV DNA quantitative detecting reagents can meet requirement of hepatitis B screening and clinical therapy monitoring, which is economic and simple for clinical routine tests.
ABSTRACT
AIM:To observe the levels of monocyte-platelet aggregates (MPA) and markers of activated monocytes in patients with unstable angina pectoris (UAP) accepting Ginkgo biloba tablet treatments,and to explore its mechanisms for cardiovascular disease treatments.METHODS:The levels of MPA,CD11b,and MCP-1 were measured in 92 unstable angina pectoris (UAP) and 42 stable angina pectoris (SAP).The UAP patients were randomly assigned into routine treatment group (control group) and combined tablet treatment group (Ginkgo biloba group).The efficacy was assessed,and the levels of MPA,CD11b,and MCP-1 were measured after 28 days of treatment,respectively.RESULTS:The levels of MPA,CD11b,and MCP-1 in UAP group were higher than those in SAP group (P＜0.001).The levels of MPA and CD11b were positively correlated with MCP-1 level (P ＜ 0.01).The total rate of effective Ginkgo biloba tablet treatment was higher than that of non-Ginkgo biloba tablet treatment (P ＜ 0.05).After 28 days of treatments,the levels of MPA,CD11b,and MCP-1 in Ginkgo biloba group were significantly lower than those in control group (P ＜ 0.001).In total effective treatment group,the levels of MPA,CD11b,and MCP-1 were significantly lower after treatment than those before treatment (P ＜ 0.001),and the decreased rates of these markers after treatment were also much higher (P ＜ 0.01).CONCLUSION:There is an obvious efficacy of Ginkgo biloba tablet on unstable angina pectoris by down-regulating the levels of MPA,CD11b and MCP-1.
ABSTRACT
Objective To investigate the effect of individualized therapeutic programs with combination of interferon and ribavirin (RBV) in chronic hepatitis C (CHC) and study the influential factors of virological response rates.Methods A total of 139 patients with CHC were enrolled and given the intensive treatment doses of interferon and RBV according to their basic clinical condition.At the treatment of 0,4,12,24 weeks,the end of treatment and 24 weeks after treatment stop,the serum HCV RNA was determined.Timely adjustment to dosage and time periods was made according to the virological response to treatment,and the predictive value of rapid virological response (RVR) and complete early virological response (cEVR) for sustained virological response (SVR) were analyzed.Results At the 4th week of treatment,the level of serum HCV RNA was monitored in 120 patients,and 84.2％ (101/120) of patients obtained RVR; among them,90.7％ (88/97) obtained SVR.The virus load of patients obtained RVR at pretherapy was lower than that of patients didn't obtained RVR [(5.883±1.246) lg copies/ml vs (6.502±0.693)lg copies/ml,P =0.034].The RVR rate of initial treatment patients with PEG-IFNα-2a [87.8％(79/90)]was significantly higher than that of retreatment patients with PEG-IFNα-2a [65.0％ (13/20)](P =0.031).At the 12th week of treatment,the level of serum HCV RNA was monitored in 132 patients,and 92.4％ (122/132) of patients obtained cEVR; among them,90.8％ (108/119) obtained SVR.The SVR rate of patients obtained cEVR was significantly higher than that of patients didn't obtained cEVR (5/9) (P =0.007).There was no significant difference between the cEVR rate of initial treatment patients [94.7％ (90/95)]and retreatment patients [85％ (17/20)]with PEG-IFNα-2a (P =0.158).Conclusions cEVR was predictor of SVR.Individualized therapy can increase the obtaining probability of RVR,cEVR and SVR.Adjusting drug dose timely and extending treatment period of HCV RNA-negative based on virological response to treatment are important in CHC individualized therapy.