The Option Of Clinical Test And The Evaluation Of Diagnosis Potency

Objective:By using the diagnostic test to gain "the best evidence" of laboratory diagnosis for rheumatism arthritis.It will ensure the laboratory diagnosisbeing scientific,effective,reliable and economical.Methods:We performed a systematic review of outcomes about laboratory diagnosis forRA by using Meta—discl.40.The study was carried on health people and patientswith RA,SLE or acute upper respiratory infection from March,2007 to June,2007.We divided them into the RA patient group (active stage,remission stage),the SLE patient group,the acute upper respiratory infection patient group and the healthy control group.We carried on the following tests in eachgroup.RFs,IL-1RI,IL-1β,CDK2,Anti-CCP and Anti-RA33 were measured by therespective ELISA assays.AKA,dsDNA and ANA were measured by the indirectimmunofluorescence.ENA was measured by Dot*blot.ASO,CRP,RF,IgG,IgA and IgMwere measured by the nephelometeric method.The respective performance of thesetests were compared using a receiver-operating characteristics (ROC)whichwas used to determine the cutoff value.We made the potency appraisal to eachexperimental data and analyzed the combination model.Results:Through the results by meta-analysis,we found that there was no onuniformityin the 15 researches about Anti-CCP;there was high nonuniformity in the 6 researches about IgM-RFs,the sensitivity and specificity was 73.0% and 70.0%;there was midrange nonuniformity in the 12 researches about AKA,thesensitivity and specificity was 42.0% and 97.0%;there were 5 researches aboutIgM-Rfs and Anti-CCP,the sensitivity were 74.0% and 65.0%,and the specificity were 64.0% and 97.0%.The AUC was 0.8 and 0.9;8 researches about AKA and Anti-CCP,the sensitivity were 36.0% and 61.0%,and the specificity were 97.0% and 96.0%.The AUC was 0.6和0.9;4 researches about AKA and IgM-RFs,the sensitivity were49.0% and 70.0%,and the specificity were 97.0% and 69.0%。The AUC was 0.8and 0.7.The related literatures about the diagnosis potency for RA of IgA-RFs,IgG-RFs and Anti-RA33 were few,therefore we did not take the meta-analysison them.In the comparison in the RA patient group between the active stage and theremission stage,the results of the sensitivity and the specificity wereIL-1β(6.0%,97.0%),CDK2(91.0%,53.0%),ENA(25.8%,79.0%),dsDNA(1.5%,100.0%),AKA(8.1%,96.5%),ANA(50.8%,4.4%),Anti-RA33(13.4%,87.7%),IgM(4.5%,96.5%);Inthe comparison between the RA patient group and the control groups(the SLEpatient group,the acute upper respiratory infection patient group and thehealthy control group),the results of the sensitivity and the specificity wereCDK2 (49.0%,88.0%),CRP (71.8%,57.1%),IgM-RFs (47.0%,99.0%),RF(62.9%,95.7%),I L-1RI (28.0%,99.0%),IgA-RFs (44.0%,99.0%),IgG-RFs (49.0%,99.0%),ENA (25.8%,55.0%),dsDNA(0.8%,94.3%),AKA(6.5%,99.3%),ANA(48.4%,52.1%),Anti-CCP(71.0%,90.0%),Anti-RA33 (15.3%,90.7%),IgA(13.7%,94.3%),IgM(4.0%,94.3%);In thecomparison between the RA patient group and the SLE patient group,the resultsof the sensitivity and the specificity were CDK2(50.0%,95.0%),CRP(71.8%,53.3%),IgM-RFs(47.0%,98.0%),RF(62.9%,93.3%),IL-1RI(28.0%,97.0%),IgA-RFs(43.0%,98.0%),IgG-RFs (50.0%,98.0%),ENA (25.8%,0.8%),dsDNA (0.8%,88.3%),AKA (6.5%,98.3%),ANA (48.4%,11.7%),Anti-CCP(71.0%,92.0%),IgM(4.0%,88.3%);In thecomparison between the RA patient group and the acute upper respiratoryinfection patient group,the results of the sensitivity and the specificitywere CDK2 (100.0%,50.0%),IgM-RFs (55.0%,95.0%),RF (62.9%,97.4%),IL-1RI(40.0%,95.0%),IgA-RFs (54.0%,95.0%),IgG-RFs (60.0%,90.0%),ENA (25.8%,84.6%),dsDNA (0.8%,97.4%),AKA (6.5%,100.0%),ANA(48.4%,84.6%),Anti-CCP(71.0%,92.3%),Anti-R A33 (15.3%,97.4%),IgA (13.7%,90.0%),IgG (15.3%,94.9%).We analyzed the combination model based on the test results.In the comparisonbetween the RA group and the control group,the sensitivity and specificitywas 82.3% and 94.1% for AKA+IL-1RI+RF;96.23% and 81.0% for Anti-CCP+RF+IgM-RFs.In the comparison in the RA patient group between the active stage and theremission stage,the sensitivity and specificity was 91.0% and 53.0% for CDK2;91. 8% and 51.2% for CDK2+AKA in the parallel tests;23.5% and 90.1% for CDK2+ENA in the serial tests.In the comparison between the RA patient group and theSLE patient group,the sensitivity and specificity was 87.4% and 85.8% forRF+IgM-RFs;96.3% and 78.7% for RF+IgM-RFs+Anti-CCP;In the comparison betweenthe RA group and the acute upper respiratory infection patient group,thesensitivity and specificity was 91.5% and 92.5% for CDK2+RF+IgA-RFs.Conclusions:The diagnosis potency from high to low for RA was Anti-CCP,AKA,IgM-RFs.Thesensitivity and specificity of Anti-CCP and IgM-RFs for RA were better.AKAhas the highest specificity for RA.Because the quantity of the literature forthe systems evaluation was limited,the quality was irregular,and there wascertain homoplasy in the domestic literature,the analysis on the potency ofRA diagnosis was incomplete,but to wait for the further research.Through analysising the various tests,we knew that CDK2,RF,IgM-RFs,IgA-RFs,IgG-RFs and Anti-CCP all had certain diagnosis significance in every differentgroup comparison.All thetests performed high specificity,but the sensitivitywas not ideal.Although each test had the respective advantage for the RAdiagnosis but also had many disadvantages.We could enhance the sensitivity and specificity by combination diagnosismodel.In the comparison in the RA patient group between the active stage andthe remission stage,we found that there was few different between CDK2+AKAin the parallel tests and CDK2.Therefor we can reduce the cost in the paralleltests by testing CDK2 only.We also found that the combination diagnoses ofCDK2+ENA in the serial tests enhanced the specificity with reducing the sensitivitygreatly.We can get different demands for clinical diagnosis with fewertests in combination diagnoses.In this research,the combination diagnosesof AKA+IgG-RFs had higher specificity which were suit for the differentialdiagnosis of RA patients and doubtful RA patients as a kind of auxiliary diagnosis.The combination diagnoses of RF+Anti-CCP+CRP+IgG-RFs in the paralleltests had the higher sensitivity which were suit for the screening of RApatients.The sensitivity and specificity of the combination diagnoses ofRF+Anti-CCP+IgM-RFs in the parallel tests were both acceptable which were suitfor early diagnosis for RA.