Buruli ulcer is a severely debilitating disease, which starts as an inconspicuous papule and degenerates in large open wounds if left untreated. The causative pathogen is Mycobacterium ulcerans. Treatments exist (antibiotics) but convenient diagnostics do not. Yet, diagnostics are critical to ensure early treatment and proper selection of the antibiotic regimen. The disease is believed to be vastly underreported and reliable epidemiological data are not available, precisely due to the lack of suitable diagnostics. It is estimated that at least 100,000 people are infected in sub-Saharan Africa, probably more. The disease is not life threatening but induces severe disability as large ulcers develop in the limbs and feet. 

A new test for Buruli ulcer is being developed under the leadership of FIND, the global alliance for diagnostics, which has a assembled a consortium of dermatologists (Nagasaki University, Japan), biologists (Swiss Tropical and Public Health Institute, Bern, Switzerland), and assay developers (Drugs & Diagnostics for Tropical Diseases, San Diego, CA), with funding from the Global Health Technology Innovation Fund (GHIT), the Medicor foundation and Anesvad.  

The test consists of a lateral flow assay that utilizes novel magnetic nanoparticles and antibodies to concentrate and detect the biomarker under scrutiny. The biomarker present in only minute amounts is collected from the wound by means of a swab and applied to the test. Like other lateral flow assays, a test and a control line appear on a nitrocellulose strip. A first-generation prototype is being evaluated in the field in Cameroon (Buruli Ulcer Laboratory Network, Centre Pasteur du Cameroun, Yaoundé) and in Ivory Coast (Hope Commission and Centre Pasteur, Abidjan). To quantify the results and for quality control purposes, the team decided to use a reader to measure the intensity of the test and control lines. The reader had to be adapted to field use and therefore be portable, rugged, and battery operated. Furthermore, data collection in a cloud-based repository was desirable to enable real-time monitoring of the results. Finally, the reader had to be cost-effective. 

iAssay Inc, a privately held developer of point of care (POC) readers for remote medical diagnostics, is proud to report that the consortium has used iAssay reader model 2030 for its field studies. While a formal reader selection process was not followed, the use of the iAssay reader was based on the urgent identified need to quantify the results of the RDT in the field after the activities had been initiated, as well on the cost, ruggedness, ease to upload data in a cloud-based repository for quick analysis, and previous experience on the use of iAssay by DDTD. Marco Biamonte, CEO of Drugs & Diagnostics for Tropical Diseases says: “The iAssay reader has lived up to expectations and has performed flawlessly. Training users proved to be easy, and it was a pleasure to note that the data was uploaded in the cloud automatically and without issues in a set-and-forget mode”.   Marco adds that even young people have large open wounds showing flesh and bones, and that seeing the frequency and magnitude of these lesions added for him a moral imperative to urgently develop a point of-care rapid test for Buruli ulcer. 

iAssay Inc., announced on January 4th, 2022, that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application 17/001,069. The allowed patent includes 19 claims, key claims relating to the processing of multiple unique test devices simultaneously in a common drawer, mechanisms for decoding identifiers, and lateral flow test results based online intensity/color. The patent application is expected to issue in mid-2022.

Featured Image: A new test for Buruli ulcer is being developed under the leadership of FIND, the global alliance for diagnostics, and iAssay. Photo: iAssay