RESUMO
Objective To compare the diagnostic value of Enzyme-linked Immunosorbent Assay(ELISA) and Toluidine Red Un-heated Serum Test(TRUST) in the diagnosis of syphilis .Methods 1500 suspected cases of syphilis in our hospital from January 2015 to December 2016 were randomly selected for clinical study .All patients were received three tests including TPPA ,ELISA and TRUST for syphilis positive detection .The results of TPPA test were taken as the gold standard to estimate sensitivity ,specificity , positive predictive value ,negative predictive value of ELISA and TRUST .Results In 1500 suspected cases ,a total of 1093 cases was diagnosed as syphilis and 407 cases were excluded .Sensitivity ,specificity ,positive predictive value and negative predictive value of ELISA were 98 .08% ,96 .07% ,98 .53% ,and 94 .09% respectively .The values of TRUST were 92 .04% ,87 .22% ,95 .08% and 80 .32% respectively .The values of ELISA method were higher than those of TRUST ,and the difference was statistically signifi-cant (P<0 .05) .Conclusion Sensitivity and specificity of ELISA method for syphilis test is relatively high ,but the results can′t re-flect the changes of the disease .Although sensitivity and specificity of TRUST assay is low ,but the results can vary with changes of patients′condition ,so they can be used as observation index for disease treatment and prognosis .Therefore ,in the process of clinical application ,two methods can be used together to improve the accuracy of the tests and guide the clinical treatment ,which can also provide a basis for the prognosis .
RESUMO
Objective To compare the detection performance of the modified serum test (TRUST) method and the traditional method in syphilis screening.Methods A series of TRUST high titer syphilis serum was diluted,and the positive rate of each method was calculated by using the improved method and the traditional method.Comparison of two detection methods of C50,C5 ～ C95 interval,as well as the accuracy of the density curve,and the consistency of the two methods were compared,and diagnostic performance were compared.Results The improved method of C50 was less than the traditional method of C50,and the improved method of C5 ～ C95 range was narrower than the traditional method,compared with the traditional method.The improved method of the non precision density curve was steeper than the traditional method,and the two confidence interval of the consistency degree of the 95％ methods was 73.4％ to 95.8％.The diagnostic sensitivity (SEN),diagnostic specificity (SPE),positive predictive value (PPV),negative predictive value (NPV) and diagnostic efficiency(DF) of the improved method were 64.29 ％,99.1％,85.71％,97.05 ％ and 96.39 ％,respectively.The SEN,SPE,PPV,NPV and DF of the traditional methods were 3.75 ％,98.49 ％,75 ％,96.18 ％ and 95 ％,respectively.The improved method was superior to the traditional methods in the two aspects of SEN and PPV (x2 =8.25,10.03,all P＜0.05),with the statistically significant difference.The improved method was slightly higher than the traditional method in SPE,NPV and DF (x2 =2.39,3.45,4.03,all P＞0.05),with the no statistically significant difference.Conclusion The precision,diagnostic sensitivity and diagnostic specificity of the improved method was higher than that of the traditional method,and it can be applied to the detection of large batch samples with the aid of the full automatic enzyme immunoassay instrument.The improved method can be used to replace the traditional method for syphilis screening.
RESUMO
Objective To explore the clinical value of five methods commonly used for the detection of clinical syphilis antibody.Methods A total of 160 confirmed syphilis cases were chosen as the experimental group while 200 non-syphilis cases were set as the control group.Serum specimens were detected by methods as Treponema pallidum particle agglutination assay (TPPA),chemiluminescent microparticle immune assay (CMIA),enzyme linked immunosorbent assay (ELISA),emulsion method (TP-AD) and toluidine red unheated serum test (TRUST).Sensitivity and specificity were evaluated on five methods.Titers of syphilis antibody in different stages and pre/post on treament among syphilis patients were compared and analyzed under the five methods.Results The sensitivity vs.specificity of TPPA,CMIA,ELISA,TP-AD and TRUST appeared as 100.00％ vs.99.50％,99.38％ vs.99.00％,98.12％ vs.99.00％,94.38％ vs.94.50％ and 85.62％ vs.95.50％,respectively.Among the patients at primary or latent stages,the syphilis antibody positive rate detected by TRUST appeared lower than that detected by ELISA,TPPA,CMIA or TP-AD,and the differences were statistically significant (P＜0.01).There were no statistical differences in the syphilis antibody positive rate of syphilis patients in the secondary or tertiary stages detected by five methods (P＞0.05).In each stage of the syphilis patients,the syphilis antibody positive rate detected by ELISA or of CMIA combined with TRUST both reached 100.00％.Before and after treatment in 121 cases of confirmed syphilis,there was statistically significant difference in the syphilis antibody positive rate detected by TRUST method (P＜0.05).There was no statistical significance in the syphilis antibody positive rate detected by other four methods (P＞0.05).Conclusions The sensitivity and specificity of TPPA,CMIA and ELISA methods were better.Methods as ELISA or as CMIA combined with TRUST both appeared reliable for syphilis screening in every stage of the disease.TRUST was suitable for the determination of active stage syphilis and monitoring the effects after treatment.
RESUMO
Objective To explore the clinical value of five methods commonly used for the detection of clinical syphilis antibody.Methods A total of 160 confirmed syphilis cases were chosen as the experimental group while 200 non-syphilis cases were set as the control group.Serum specimens were detected by methods as Treponema pallidum particle agglutination assay (TPPA),chemiluminescent microparticle immune assay (CMIA),enzyme linked immunosorbent assay (ELISA),emulsion method (TP-AD) and toluidine red unheated serum test (TRUST).Sensitivity and specificity were evaluated on five methods.Titers of syphilis antibody in different stages and pre/post on treament among syphilis patients were compared and analyzed under the five methods.Results The sensitivity vs.specificity of TPPA,CMIA,ELISA,TP-AD and TRUST appeared as 100.00％ vs.99.50％,99.38％ vs.99.00％,98.12％ vs.99.00％,94.38％ vs.94.50％ and 85.62％ vs.95.50％,respectively.Among the patients at primary or latent stages,the syphilis antibody positive rate detected by TRUST appeared lower than that detected by ELISA,TPPA,CMIA or TP-AD,and the differences were statistically significant (P＜0.01).There were no statistical differences in the syphilis antibody positive rate of syphilis patients in the secondary or tertiary stages detected by five methods (P＞0.05).In each stage of the syphilis patients,the syphilis antibody positive rate detected by ELISA or of CMIA combined with TRUST both reached 100.00％.Before and after treatment in 121 cases of confirmed syphilis,there was statistically significant difference in the syphilis antibody positive rate detected by TRUST method (P＜0.05).There was no statistical significance in the syphilis antibody positive rate detected by other four methods (P＞0.05).Conclusions The sensitivity and specificity of TPPA,CMIA and ELISA methods were better.Methods as ELISA or as CMIA combined with TRUST both appeared reliable for syphilis screening in every stage of the disease.TRUST was suitable for the determination of active stage syphilis and monitoring the effects after treatment.