Objective To explore the measurement of(1,3)-β-D glucan in plasma for the diagnosis of pulmonary fungal infections in pulmonary tuberculosis patients. Methods 40 pulmonary tuberculosis patients with pulmonary fungal infections in Guangzhou chest hospital from January 2015 to December 2015 were enrolled as a test group,among which 35 were confirmed and 5 were suspected pulmonary fungal infections. 52 pulmonary tuber-culosis patients without fungal infections were selected as a control group.(1,3)-β-D glucan content(G test)in this 92 patients plasma were detected. The results of G tests were compared with those from etiological diagnosis to assess the performance of G test. Results 13 strains of candida albicans,13 strains of aspergillus,2 strains of candida tropicalis,2 strains of candida glabrata and 6 strains of other yeast were obtained from patients of test group,but no fungal identified from those of control group. The median of G test in test group and in control group was 126.1 and 29.56 pg/mL,respectively,the level in test group was significantly higher than that in control group (P<0.001). 35 cases were identified as positive and 5 were negative in test group by G test ,while 41 cases were identified as negative and 11 were positive in control group. The sensitivity,specificity,positive predictive value, negative predictive value ,concordance and Youden index of G test were 87.5%,78.85%,76.09%,89.13%, 82.6%and 0.663,respectively. Conclusions Candida albicans and aspergillus are more common pathogens than the other fungi isolated from pulmonary tuberculosis patients with pulmonary fungal infection. G test ,used in pul-monary tuberculosis with pulmonary fungal infections diagnosis,is reliable and fast,and has a higher sensitivity, specificity and accuracy.

In recent years, monoclonal antibodies (mAbs) have been developing rapidly and widely used in fields of tumor, immunity, blood and other systemic diseases. Global share of mAbs in prescription drug market had reached up to $ 140 billion, 15.3% by 2019. As macromolecule proteins, with special structures and physiological properties, mAbs have great differences in absorption, distribution, metabolism and excretion in vivo compared with small molecule drugs, including characteristics of relatively large molecular mass, high specificity and selectivity in target combination, non-linear pharmacokinetics, time dependence, long half-life and so on. Fully understanding of these special pharmacokinetic characteristics shall effectively guide analysis of mAbs. Meanwhile, the particularity and complexity of disposal mechanism in organisms greatly increase the difficulty of biological detection. As a result, it is necessary to establish exclusive, sensitive, accurate and repeatable quantification methods in biological samples. This article focuses on pharmacokinetic characteristics, main analytical methods, and methodology validation of quantification for mAbs in biological samples, expounding with comparisons of small molecular drugs, so as to prompt development of pharmacokinetic study of this kind of drugs.