Dataset Information

Evaluation of an Aspergillus IgG/IgM lateral flow assay for serodiagnosis of fungal asthma in Uganda.

ABSTRACT:

Background

Diagnosis of fungal allergies in asthma remains problematic in low-and middle-income countries due to non-availability of point-of-care testing. In this study, we aimed to evaluate the performance of an Aspergillus immunochromatographic technology (ICT) IgG/M lateral flow device (LFD) for the serological diagnosis of allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitisation (SAFS) among Ugandan adult asthmatics.

Methods

374 adult (aged ≥18years) asthmatics in the African Severe Asthma Program study, Ugandan site constituted the study population. ABPA and SAFS were diagnosed according to standard criteria. Asthmatics who did not meet the above criteria constituted a control group. The LFD tests were performed and read according to manufacturer's instructions.

Results

ABPA was found in 12/374 (3.2%) and SAFS in 60/374 (16%) participants. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the Aspergillus ICT for the diagnosis of ABPA were 0.0%, 96.4%, 0.0% and 96.7% respectively, and for SAFS 6.7%, 97.1%, 30.8% and 84.5% respectively. False positive and negative rates were 3.5% and 3.2% for ABPA and 2.4% and 14.9% for SAFS, respectively. Patients with a positive LFD significantly had higher median Aspergillus fumigatus-specific IgE levels compared to those with negative LFD (median: 0.06 kUA/l VS 0.03 kUA/L, P = 0.011).

Conclusion

The Aspergillus ICT IgG/M LFD had a poor diagnostic performance for the diagnosis of both ABPA and SAFS. Its greatest value may be in distinguishing chronic and allergic aspergillosis in Africa.

SUBMITTER: Kwizera R

PROVIDER: S-EPMC8162618 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Last year, the novel coronavirus disease (COVID-19) emerged in Wuhan, and it has rapidly spread to many other countries and regions. COVID-19 exhibits a strong human-to-human transmission infectivity and could cause acute respiratory diseases. Asymptomatic carriers are able to infect other healthy persons, and this poses a challenge for public health; the World Health Organization (WHO) has already announced COVID-19 as a global pandemic. Nucleic acid testing, considered as the current primary method for diagnosing COVID-19, might lead to false negatives and is difficult to be applied for every suspected patient because of the existence of asymptomatic carriers. Meanwhile, detecting specific antibodies in blood, such as the IgM antibody, against the SARS-CoV-2 virus is another choice for COVID-19 diagnosis, as it is widely accepted that IgM is an important indicator in the acute infection period. In this study, a colloidal gold nanoparticle-based lateral-flow (AuNP-LF) assay was developed to achieve rapid diagnosis and on-site detection of the IgM antibody against the SARS-CoV-2 virus through the indirect immunochromatography method. For preparing AuNP-LF strips, the SARS-CoV-2 nucleoprotein (SARS-CoV-2 NP) was coated on an analytical membrane for sample capture, and antihuman IgM was conjugated with AuNPs to form the detecting reporter. Optimization of AuNP-LF assay was carried out by altering the pH value and the amount of antihuman IgM. The performance of AuNP-LF assay was evaluated by testing serum samples of COVID-19 patients and normal humans. The results were compared with the real-time polymerase chain reaction. The sensitivity and specificity of AuNP-LF assay were determined to be 100 and 93.3%, respectively, and an almost perfect agreement was exhibited by Kappa statistics (κ coefficient = 0.872). AuNP-LF assay showed outstanding selectivity in the detection of IgM against the SARS-CoV-2 virus with no interference from other viruses such as severe fever with thrombocytopenia syndrome virus (SFTSV) and dengue virus (DFV). AuNP-LF assay was able to achieve results within 15 min and needed only 10-20 μL serum for each test. As a whole, in the light of its advantages such as excellent specificity and stability, easy operation, low cost, and being less time-consuming, AuNP-LF assay is a feasible method for the diagnosis of COVID-19 in primary hospitals and laboratories, especially in emergency situations in which numerous samples need to be tested on time.