Evaluation of domestic serum galactomannan detection kit for the diagnosis of invasive pulmonary aspergillosis

Abstract

Abstract: Objectives To evaluate the performance of domestic serum galactomannan (GM) test kit for the diagnosis of invasive pulmonary aspergillosis.Methods According to the reference standards set by the diagnostic criteria and treatment of invasive pulmonary fungal infection principle^[1],the serum of confirmed invasive pulmonary aspergillosis (IPA),clinical diagnosis of IPA,suspected IPA and without IPA were collected.Using Tianjin Bio-Enoche reagent kit of ELISA method, 86 specimens were analyzed to calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV).Results All 86 clinical cases are consisted of 27 clinical proven IPA, 12 probable IPA, 47 without IPA. According to the three different kinds of positive judgment standard, the degree of sensitivity, specificity,PPV,NPV is respectively, sensitivity: 94.44%, 96.30%, 62.96%;Specificity:94.44%,96.30%, 62.96%;PPV:94.44%,96.30%,62.96%;NPV: 94.44%, 96.30%,62.96%. Statistical analysis confirmed that standard No.1 (The positive GM test was defined as GM value >0.95 μg/L and the negative defined as <0.75 μg/L) was the optimal, so standard No.1 was choosed as the final judgment standard.Conclusion Performance of the domestic serum GM detection kit is eligible and can be used for the auxiliary diagnosis of invasive pulmonary aspergillosis.

Key words: invasive pulmonary aspergillosis, galactomannan, enzyme linked immunosorbent assay

CLC Number:

WANG Yuan-fang, KANG Mei, YUAN Yu, HUANG Yan-chun, MA Ying. Evaluation of domestic serum galactomannan detection kit for the diagnosis of invasive pulmonary aspergillosis[J]. Chinese Journal of Mycology, 2014, 9(5): 275-278.

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