Multicenter Evaluation of a Novel Immunochromatographic Test for Anti-aspergillus IgG Detection

Abstract

Aspergillus sp. fungi cause various diseases in both immunocompetent and immunocompromised patients. The most frequent Aspergillus disorders include chronic pulmonary aspergillosis (CPA), a life-threatening disease that affects at least 3 million people worldwide, and allergic bronchopulmonary aspergillosis (ABPA), which affects approximately 4.8 million severe asthmatic patients globally. Diagnosis of such diseases involves IgG serological testing; however, the currently available anti-Aspergillus IgG detection assays are inappropriate for resource-poor laboratory settings, as they are expensive, rely on automated procedures, and require stable electrical power. Therefore, accurate CPA or ABPA diagnosis facilities are lacking in most low- and middle-income countries. We evaluated a novel anti-Aspergillus antibody immunochromatographic test (ICT) that requires minimal laboratory equipment. Two evaluations were performed: a single-center 4-month prospective study in a French reference laboratory (44 cases/257 patients) and a retrospective study in five French reference laboratories (262 cases and 188 controls). We estimated the ICT indices for the diagnosis of chronic aspergillosis, and the test results were compared to those of anti-Aspergillus IgG immunoblot (IB) assay. Of the 713 patients included in the study, 306 had chronic aspergillosis. Test sensitivity and specificity were 88.9% (95%CI[85–92]) and 96.3% (95%CI[94–98]) for the ICT and 93.1% (95%CI[90–96]) and 94.3% (95%CI[92–96]) for the IB, respectively. Agreement between the two assays was almost perfect (kappa = 0.86). As this ICT displays good diagnostic performance and complies with the ASSURED (Affordable, Sensitive, Specific, User-friendly, Equipment-free, and Delivered) criteria, we concluded that this anti-Aspergillus antibody ICT can be used to diagnose Aspergillus diseases in resource-poor settings.

Evaluation of LDBio Aspergillus ICT Lateral Flow Assay for IgG and IgM Antibody Detection in Chronic Pulmonary Aspergillosis

“…The test is easy to perform, and we found visual interpretation to be as reliable as digital detection. Furthermore, the test has been shown to operate reliably under conditions of high temperature and humidity (16) and requires minimal laboratory equipment and no power source, important features for implementing diagnostics in resource-constrained settings. While not quantitative and therefore not suitable for monitoring CPA treatment, overall, the LDBio Aspergillus ICT test exhibits excellent performance as a screening tool in the CPA diagnostic pathway.…”

“…LDBio Diagnostics (Lyons, France) has introduced a new point-of-care lateral flow assay (LFA) (LDBio Aspergillus ICT) for detection of Aspergillus antibodies (IgG and IgM). The assay utilizes immunochromatographic technology (ICT) and has recently been validated against a spectrum of Aspergillus -related diseases (16), including a moderate number ( n = 79) of CPA cases. It has been demonstrated to meet the ASSURED (“affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free, and deliverable to end users”) criteria outlined by the World Health Organization (16) and therefore would be compatible with resource-constrained settings.…”

“…The assay utilizes immunochromatographic technology (ICT) and has recently been validated against a spectrum of Aspergillus -related diseases (16), including a moderate number ( n = 79) of CPA cases. It has been demonstrated to meet the ASSURED (“affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free, and deliverable to end users”) criteria outlined by the World Health Organization (16) and therefore would be compatible with resource-constrained settings. In this study, we evaluated the performance of the LDBio Aspergillus ICT LFA as a rapid serological test specifically for CPA diagnosis, using serum from patients with known CPA and case-matched healthy controls.…”

Evaluation of the LDBio Aspergillus ICT lateral flow assay for serodiagnosis of allergic bronchopulmonary aspergillosis

“…LDBio Diagnostics (Lyons, France) has introduced a new point-of-care lateral flow assay ( Aspergillus IgG-IgM ICT) for detection of Asp antibodies. The assay utilizes immunochromatographic technology (ICT) and has been validated against a spectrum of Aspergillus -related diseases [ 15 ], including a moderate number (n = 74) of ABPA cases. We recently evaluated patients with CPA and found this assay to have a sensitivity of 90.6% and a specificity of 98.0% [ 16 ].…”

Algorithm-aided diagnosis of chronic pulmonary aspergillosis in low- and middle-income countries by use of a lateral flow device

“…* Felix Bongomin drbongomin@gmail.com 1 diagnosis of CPA in LMIC [12]. As a consequence, simplified algorithms for the diagnosis of CPA in resource-constrained settings were published [13,14] to permit early and correct diagnosis and appropriate management of the disease.…”