Chronic Pulmonary Aspergillosis Clinical Trial
Official title:
Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA) in Chinese Patients -Multicenter Study
Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA)
chronic pulmonary aspergillosis (CPA) is one of the most refractory pulmonary infectious
diseases, and the incidence is increased rapidly in recent years. Serum detection of
Aspergillus-specific IgG is considered to be the most reliable method for diagnosing CPA,
however, there is no formal report on the appropriate cut-off value for Aspergillus-specific
IgG assay in Chinese patients. This study aimed to establish the datum.
Besides aspergillus-specific IgG, there are two other specific antibodies IgM and IgA. IgM
is associated with the acute phase of an infection and IgA is associated with mucosal
immunity. Their diagnostic values in CPA are still not clear. Meanwhile, whether detection
of antibody levels in bronchoalveolar lavage fluid (BALF) could be useful in diagnosis of
CPA has not been investigated. In this study, the serum and BALF levels of IgG, IgM and IgA
would be detected simultaneously by the commercial available kits.
The investigators will establish the cut-off values of three antibodies by proven CPA
patients and negative controls. Then, the cut-off values will be assessed in participants
who have a suspected CPA, and the sensitivity, specificity, positive and negative predict
value of the antibodies assays will be compared with that of standard diagnostic methods.
After performing the above diagnostic tests, CPA could be diagnosed more accurately and
rapidly, so that the antifungal therapy could be evaluated more correctly and timely.
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