Exponential Deep Examination (EDE) scanner is an innovative device designed to detect infectious diseases and antimicrobial resistance, developed by the parent company of Servizi EDE Research LLC, which has been carrying out research and scouting technology for more than 10 years, developing, among the others, a technology for non-invasive genome detection. Such technology can detect electromagnetic (EM) waves from individuals within a 2–5 meter radius. As EM waves differ among healthy (non-infected) versus infected individuals due to presence of pathogenic DNA/RNA sequences, the technology classifies these EM waves based on their spectral signatures and subsequently identifies the pathogen based on its corresponding sequence.

The technology researched and fine-tuned by the parent company of Servizi EDE Research LLC comprises three main elements: (1) An EDE detector (sensor) to measure EM waves; (2) A portable targeting device: Android based device (smartphone) connected to the internet to transmit information and point to a certain individual and display information; and (3) A machine learning (ML) model to identify the spectral signature compatible with the specific pathogen.

The same technology was used by the parent company of Servizi EDE Research LLC as a component to develop and fine-tune another type of scanner, which demonstrated high accuracy in detecting the Coronavirus Disease 2019 (COVID-19) (i.e., the COVID-19 EDE scanner). When tested in the Emirate of Abu Dhabi in the United Arab Emirates (UAE), the COVID-19 EDE scanner showed device sensitivity and specificity of 96.7% and 98.12%, respectively, against the gold standard COVID-19 polymerase chain reaction (PCR) test. Moreover, similar results were shown in a study conducted by the Abu Dhabi Health Services Company (SEHA) and Union 71 laboratory testing firm, whereby analysis of 1,093 patient samples yielded a sensitivity and specificity of 93.5% and 83.0%, respectively, in the detection of COVID-19 using the COVID-19 EDE scanner. Based on these data, the Health Department of Abu Dhabi approved the use of COVID-19 EDE scanner as a screening technology in the detection of COVID-19, whereby individuals screened positive for COVID-19 via the scanner would subsequently undergo RT-PCR testing to confirm the diagnosis of COVID-19. The COVID-19 EDE Scanner was widely used as a mandatory screening tool to detect COVID-19 at land/air entry points, shopping malls and residential areas in Abu Dhabi during the COVID-19 pandemic.

The EDE scanner has the potential to detect other pathogens as well, including human immunodeficiency virus (HIV), tuberculosis (TB), and hepatitis C (HCV), as demonstrated through a preliminary study by Servizi EDE Research LLC (100% sensitivity and specificity in detection of HIV, TB, and HCV). This preliminary study was conducted among 74 patients from hospitals across the UAE that included patients suspected of HIV as well as confirmed cases of HCV and TB. The EDE scanner successfully detected all the suspected and symptomatic  patients with HIV, HCV, and TB, as confirmed against the standard diagnostic tests performed for each of these infections (HIV: HIV viral load and HIV antibody test; HCV: anti-HCV antibody test and nucleic acid test; TB: acid fast bacilli test). Furthermore, EDE scanner may be used to detect antimicrobial resistance. Thus, with prospects to detect a wide range of pathogens and antimicrobial resistance, the EDE scanner has the potential to be used in various settings, including visa screening centers, hospitals, clinics, laboratories, airports, malls, land/air entry points, as well as for other commercial purposes.

Unique features of the EDE scanner include its ability to generate results in real-time (immediately), and its non-invasiveness (no direct contact is required). The device can be used as a screening tool to prompt further diagnostic testing. Such novel diagnostic screening technology is even more important in countries with limited resources and limited access to conventional diagnostic laboratory infrastructure. These technological advancements may reduce the existing gap between diagnostic needs and diagnostic access especially in the middle- and low- income countries (such as African countries), where despite the substantial burden of infectious diseases, only 19% of patients have access to appropriate diagnostics at the primary health care level.

The African continent bears the largest burden of infectious diseases worldwide. Of the estimated 10 million deaths globally per year caused by infectious diseases, the majority occur in Africa. Key contributors to this excessive burden include widespread HIV, malaria, and TB infections, which together account for nearly over 1.2 million deaths per year on the continent. Within the continent, HIV and malaria are highly prevalent across South Africa and Kenya, which are also among the 30 countries worldwide with high burden of TB and MDR-TB.

Early and accurate diagnosis of an infectious disease such as HIV, TB and malaria is very important in helping control the burden the such an infectious disease. Early and accurate diagnosis enables early initiation of treatment before the start of complications.

The current mainstay of diagnosis in all these infectious diseases involve invasive techniques and which do not give real time results. The mainstay of malaria, HIV and TB diagnosis has been blood smear for malaria microscopy, HIV antibody testing and sputum for microscopy (acid fast bacilli) and culture or gene expert respectively. The need for waiting time to get the results makes the diagnostic tests above not very useful for screening, especially in the community.

As a consequence of the unmet need for an ideal screening test for these highly prevalent diseases, EDE research institute is investigating a device, that has a potential to diagnose malaria, TB and HIV in both asymptomatic and symptomatic individuals.

This is a multinational, multicenter, cross-sectional observational study in which approximately 2320 eligible participants, male and female, aged 18 years and above will be recruited in 3 groups. We propose to recruit at about 500 participants, 18 years and above at the ACTU site. The duration of participation for each participant will be approximately 1 day, inclusive of recruitment and follow up of the participants until study conclusion.

All statistical analyses described in the main protocol will be applied based on the same methodology independently, unless otherwise specified.

The publication of the results of the trial will be done in peer reviewed scientific journals in accordance with the governing clinical trial agreement, presented at scientific conferences and findings communicated to the local community through the Community Health Volunteers, Ministries of Health. Individual participants may also be reached and provided with the information if they wish to receive it individually.

The data obtained in this study will be used to validate the EDE scanner for the diagnosis of malaria, tuberculosis and HIV.