Assessing Diagnostic Methods for Invasive Fungal Disease in Lung Transplant Recipients

Guangzhou Institute of Respiratory Disease109 enrolled

Overview

This study aims to assess the diagnostic performance of different tests, including metagenomic next-generation sequencing (mNGS), real-time PCR, galactomannan assay, and lateral-flow device tests, in detecting invasive fungal disease in lung transplant recipients using bronchoalveolar lavage fluid samples. The study is retrospective and cross-sectional in design.

This retrospective, cross-sectional study evaluates the diagnostic accuracy of various tests in detecting invasive fungal disease (IFD) in lung transplant recipients. The diagnostic methods under assessment include metagenomic next-generation sequencing (mNGS), real-time polymerase chain reaction (PCR), galactomannan (GM) assay, and lateral-flow device (LFD) testing, all performed on bronchoalveolar lavage fluid (BALF) samples. The study analyzes the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each method for diagnosing invasive pulmonary aspergillosis (IPA) and Pneumocystis jirovecii pneumonia (PJP). The sample cohort consists of 109 lung transplant recipients, with data collected from January 2015 to April 2023

Study Type

OBSERVATIONAL

Enrollment

109

Conditions

Invasive Fungal Disease Lung Transplant Recipients Invasive Pulmonary Aspergillosis Pneumocystis Jirovecii Pneumonia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult lung transplant recipients aged 18 years and older. * Suspected cases of invasive fungal infection (invasive pulmonary aspergillosis or -Pneumocystis jirovecii pneumonia) based on clinical symptoms, radiological findings, or microbiological evidence. * Able to provide sufficient bronchoalveolar lavage fluid (BALF) samples for diagnostic testing. Exclusion Criteria: * Patients with confirmed non-fungal infections. * Patients unable to provide adequate BALF samples for analysis. * Patients with severe comorbidities that prevent study participation or completion.

Outcomes

Primary Outcomes

Diagnostic Accuracy of mNGS for Invasive Pulmonary Aspergillosis and Pneumocystis jirovecii Pneumonia

Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of metagenomic next-generation sequencing (mNGS) in diagnosing invasive pulmonary aspergillosis (IPA) and Pneumocystis jirovecii pneumonia (PJP) using bronchoalveolar lavage fluid (BALF) samples.

Time frame: From January 2015 to April 2023

Secondary Outcomes

Comparison of Diagnostic Accuracy between mNGS and Other Methods

Comparative analysis of diagnostic accuracy, including sensitivity and specificity, between mNGS, real-time PCR, Galactomannan (GM) assay, and lateral-flow device (LFD) tests for detecting IPA and PJP in lung transplant recipients.

Time frame: From January 2015 to April 2023.