Performance Evaluation of Fluorescence Immunochromatography Kit in Detection of Procalcitonin

  Objective  To evaluate the performance of fluorescence immunochromatography kit in detecting procalcitonin.

  Methods  According to the Clinical and Laboratory Standards Institute(CLSI) EP5-A and EP6-A, the performance of fluorescence immunochromatography kit (TEBSUN) in detecting procalcitonin was evaluated in the aspects of precision, linearity, methodology comparison, relative sensitivity, and relative specificity.

  Results  The fluorescence immunochromatography kit showed high precision, the coefficients of variation (CV) of low and high concentration samples were 8.3% and 4.7%, respectively. Result of liner verification test showed good linear correlation within the indicated test range (r=0.9989).In methodology comparison tests, the fluorescence immunochromatography kit had good consistency with VIDAS enzyme-linked immunofluorescence kit (r=0.9770).The relative sensitivity and specificity of the fluorescence immunochromatography kit compared with the enzyme-linked immunofluorescence kit were both higher than 86% at 0.5 ng/ml and 2.0 ng/ml level. The total consistency of the two diagnostic kits was 93.75%.

  Conclusion  The fluorescence immunochromatography kit has good performance in precision, linearity, methodology comparison, relative sensitivity, and relative specificity, suggesting that it meets the requirements of clinical tests.