Clinical evaluation of the RAMP200 fluorescence immunoassay analyzer

Objective Abiding by the laboratory quality requirement,to evaluate the performance of RAMP200 fluorescence immunoassay analyzer.Methods According to Series of documents of the American Society of Clinical and Laboratory Standards Institute(CLSI),following six items:the total precision,functional sensitivity,analytical measurement range,reportable range,the deviation between the holes,biological reference interval of RAMP200 fluorescence immunoassay analyzer were verified and evaluated.Results When BNP concentration levels were 80.4 and 1 169.6 pg/mL,the total precisions were 4.9% and 4.02%.The functional sensitivity was 10.58 pg/mL.The analytical measurement range was from 10.2 pg/mL to 1 805.0 pg/mL.The clinical reportable range was from 10.58 pg/mL to 5 415.0 pg/mL.The maximum deviation between the hole was 14.27%.Biological reference interval was from 15 to 86 pg/mL(Vendor reference interval 100 pg/mL).Conclusion The parameters of RAMP200 fluorescence immunoassay analyzer are consistent with the parameters provided by the vendor,so it can fit the clinical quality demand and it is suitable for the POCT.