ABSTRACT
<p><b>OBJECTIVE</b>To analyze the clinical performance of TP antibody detection by CLIA kits and evaluate whether the CLIA kits made in China is suitable for clinical use.</p><p><b>METHODS</b>1200 samples were collected from Beijing Hospital including 300 samples with confirmed TP infection and 900 healthy control samples. To detect the TP antibody of the 1200 sanples separately by the CLIA kits and the ELISA kits at the same time. The test results were analyzed with statistical methods.</p><p><b>RESULTS</b>The sensitivity and specificity of the CLIA kits were 99.3% and 99.9% respectively, and positive predictive value of 99.7%, negative predictive value of 100%. With the ELISA method, the positive coincidence rate was 98.7%, the negative coincidence rate was 99.8%, and the total coincidence rate was 99.5%.</p><p><b>CONCLUSION</b>The CLIA kits showed good clinical performance and the agreement rate with the ELISA kits was. The CLIA kits are suitable for clinical use.</p>
Subject(s)
Humans , Antibodies, Bacterial , Blood , China , Enzyme-Linked Immunosorbent Assay , Economics , Methods , Luminescent Measurements , Economics , Methods , Reagent Kits, Diagnostic , Economics , Sensitivity and Specificity , Syphilis , Blood , Diagnosis , Syphilis SerodiagnosisABSTRACT
<p><b>OBJECTIVE</b>To analyze the clinical performance of free prostate-specific antigen (fPSA) detection by ECLIA method, and evaluate whether ECLIA is suitable for clinical use.</p><p><b>METHODS</b>341 samples were collected and tested prostate-specific antibodies with CMIA and ECLIA methods. These samples contain: 97 samples with abnormal high PSA value tested by CMIA method, and 244 normal PSA samples. Use CMIA as the reference method, and detect fPSA, tPSA levels, and the ratio of fPSA/tPSA. Analyze the testing results with statistical methods.</p><p><b>RESULTS</b>Compared with CMIA, correlation coefficent of ECLIA fPSA detection is 0.99; correlation coefficent of f/tPSA ratio detection is 0.96; the sensitivity, specificity of ECLIA f/tPSA ratio detection are 85.71%, 92.6% respectively, the agreement rate with ECLIA is 87.4%. No cross reaction with bilirubin, lipohemia, hemolysis, RF, CEA, AFP, CA125, CA153, CA199 were found in the tests.</p><p><b>CONCLUSION</b>The ECLIA method for free prostate-specific antigen detection showed good clinical performance; and is suitable for clinical use.</p>
Subject(s)
Humans , Male , Electrochemical Techniques , Methods , Prostate-Specific Antigen , Blood , Prostatic Neoplasms , Blood , Diagnosis , Sensitivity and SpecificityABSTRACT
Objective To analyze the clinical performance of hepatitis C virus antibody detection by bi-direetional lateral flow method and evaluate whether the bi-directional lateral flow method is suitable for clinical use.Methods Four hurdred and nineteen samples were collected and tested anti-HCV antibodies with hi-directional lateral flow and CMIA kits.These samples contain:107 patients with confirmed hepatitis C virus infection,162 patients with other diseases than hepatitis C virus infection and 150 healthy controls.Two positive reference materials for ELISA were tested at the same time.The testing results were analyzed with statistical methods.Results Compared with RIBA,the sensitivity and specificity of bi- directional lateral flow method were 98.1% and 99.7% respectively,the agreement rate with CMIA was 99.0%.The reproducibility percentage of the+/-20% at the cutoff concentration were 97% and 99% respectively.No crossing reaction with hepatitis A/B/D/E virus infection and HIV-1/2 positive individuals were found in the tests.Conclusion The hi-directional lateral flow method for HCV detection shows good clinical performance and is suitable for clinical use.