The Performance Verification and Consistency Evaluation of Four Amyloid A Immunoturbidimetry Reagents
Objective To evaluate the performance and consistency among four Amyloid A(SAA)reagents.Methods After clinical testing,the residual serum samples were collected and tested for precision,linearity,interference,and reference interval using the CLSI guidelines.Four types of SAA reagents were used and labeled as A to D.Results The four reagents(A-D)were found to have a repeatability and in-laboratory imprecision of less than 4％.The results were all linear within the claimed analytical measurement range,with R2 of greater than 0.99.The dilution recovery of the four reagents were as follows:90.0％-103.1％,90.3％-138.1％,116.9％-131.2％,and 97.5％-102.0％,respectively.Twenty healthy individuals were tested,and 18(90％)of each reagent had test results within the reference range provided by the manufacturer.A total of 47 clinical samples were compared with the mean of the test results of the four reagents.The results showed as follows for four reagents:11 cases(23.4％),13 cases(27.7％),3 cases(6.4％),and 6 cases(12.8％)were biased by more than±15％,respectively.The percentage deviation of free bilirubin≤364.8μmol/L,conjugated bilirubin ≤327.7μmol/L,hemoglobin ≤4.98g/L,and chyle ≤1599.2 FTU were all within±10％.Conclusion The four immunoturbidimetric SAA reagents tested on an automatic biochemical analyzer can meet manufacturer's claims for precision,linearity,and anti-interference.However,some reagents did not meet the requirements for dilution and recovery.The consistency of clinical sample results among different reagents needs further improvements.Therefore,clinical laboratories should conduct more strict evaluations before selecting these reagents.
NETL
NSTL
万方数据
