Preliminary evaluation of hypersensitive C-reactive protein rapid quantitative chemiluminescent detection kit / 国际检验医学杂志

ABSTRACT

Objective To evaluate the performance of the hypersensitive C-reactive protein(hs-CRP) rapid quantitative chemilu-minescent detection kit .Methods According to National Committee for Clinical Laboratory Standards (NCCLS) EP10-A2 docu-ment ,hs-CRP rapid quantitative chemiluminescent detection kit was employed to measure the CRP at low ,medium and high con-centration levels of quality control serum .Bias ,total imprecision and their slope rates ,intercepts ,carryover ,non-linearity and drift were calculated ,and its clinical acceptability was evaluated .Results Bias and total imprecision of hs-CRP rapid quantitative chemi-luminescent detection kit were within the allowable ranges ,the average values of slope rates ,intercepts ,carryover ,non-linearity and drift were 1 .005 7 ,0 .537 8 ,0 .789 6% ,0 .019 2 ,0 .036 0 ,respectively ,the differences showed no statistically significance ( P>0 .05) .Conclusion hs-CRP rapid quantitative chemiluminescent detection kit has good accuracy and precision ,stable perform-ance ,and consistent with the clinical testing requirements .