ABSTRACT
Objective To explore colloidal gold method used to detect fecal occult blood tests(FOB)detection capability and establish the laboratory standard operation of detecting FOB limit of blank(LOB),limit of detection (LOD)and quantifica-tion limit (LOQ)according to the CLSI document《Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures;Approved Guideline-Second Edition》(EP17-A2),in order to reduce the false negative rate of the weakly positive samples,and to provide a way of quantitative detection for qualitative detection of colloidal gold method.Methods Detected series of solution of hemoglobin made of dissolved fresh whole blood with the ELISA kit of human free hemoglobin,and es-tablished the standard curve of detection of FOB with colloidal gold method.Detected the blank samples and a series of low concentration samples with the colloidal gold test strip of FOB and measured the color bands by the Nato Checker710.The quantitative results obtained were statistically analysised by SPSS 1 9.0 and calculated blank limit,detection limit and quanti-fication limit.Results The LOB,LOD and LOD were 99.01,340.48 and 354.9 ng/ml according to the methods in CLSI EP1 7-A2 ducument.Conclusion The detection limits established by CLSI EP1 7-A2 document was more scientific in j udge-ment positive or negative to FOB than which used naked eye and can meet the clinical laboratory and clinical doctor require-ment better.Clinical laboratories should be strictly in detection limits of reagents in order to ensure their effectiveness,and should be generaly to other tests based on colloidal gold method.
ABSTRACT
Limit of detection is one of most important indicators of methodological evaluation.In consideration of the misunderstanding and incorrect differentiating sensitivity and limit of detection by clinical laboratory , equipment and reagent manufacturers and journals of laboratory medicine , this article would show detailed analysis and comparison to figure out the proper use method.
ABSTRACT
Objective To evaluate the limit of blank (LoB),limit of detection (LoD),limit of quantitation(LoQ)and functional sensitivity (FS)of prealbumin (PA)detected by the Roche Modular P automatic biochemical analyzer.Methods According to the EP17A file of the American Clinical and Laboratory Standards Institute (CLSI),saline as the blank sample and a series of low con-centration samples were detected by the Roche Modular P automatic biochemical analyzer for determining LoB,LoD and LoQ.And FS was determined based on the domestic universal method .Results LoB of PA was 16.35 mg/L,LoD was 18.23 mg/L,LoQ was temporarily unable to evaluate and FS was 25.00 mg/L.The report scope and the report mode in clinic were affirmed by combi-ning with the low value of the reportable scope.Conclusion LoD of PA detected by the Roche Modular P automatic biochemical an-alyzer is established,which provides more valuable information for clinical diagnosis and treatment.Conducting the comparison of different evaluation methods determines the advantages and limitation of the practical application of different methods.