| Inclusion criteria
For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV):
• Male or female, aged ≥18 years
• Asymptomatic/symptomatic patients suspected of HIV, or symptomatic patients suspected of TB,
malaria, or HCV based on physician’s clinical evaluation, which may include laboratory (eg, liver
function tests, CBC) or radiological (eg, chest X-ray) tests per routine clinical practice
• Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for the
respective infectious disease (HIV/TB/malaria/HCV) - per routine standard of care, in parallel
• Provision of signed informed consent
For Group 2 (healthy participants):
• Male or female, aged ≥18 years
• Healthy participant, as determined by physician’s judgment
• Participant undergoing routine blood test as per standard of care
• Participant agrees to undergo non-invasive EDE scanner test
• Participant permits use of the routine blood sample to conduct a standard diagnostic test for HIV,
malaria, or HCV; or, participant agrees to provide a sputum sample to conduct a standard diagnostic test
for TB
• No evidence of active infectious disease or any infectious disease in the past 8 weeks
• No history of any of the following in the past 6 months (at minimum): close contact with infected
patients or infectious disease department, open/unprotected relations, drug abuse, blood transfusions
• Provision of signed informed consent
For Group 3 (suspected MDR-TB patients):
• Male or female, aged ≥18 years
• Patients with documented pulmonary TB due to strains of Mycobacterium tuberculosis, currently on TB
treatment as per routine clinical practice and suspected of MDR-TB based on physician’s clinical
evaluation (eg, lack of treatment response to both isoniazid and rifampicin)
• Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for MDRTB (per routine standard of care), in parallel
• Provision of signed informed consent |
Exclusion criteria
For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV):
• Current or previous history of treatment for HIV, TB, malaria, or HCV
• Patients suspected to be co-infected with more than one of the infectious diseases of interest
(HIV/TB/malaria/HCV)
• Current or previous participation in any investigational drug or medical device study in the past 3
months
• Patients on any concomitant antibiotic or antiviral treatment
For Group 2 (healthy participants):
• Current or previous participation in any investigational drug or medical device study in the past 3
months
• Participants on any concomitant antibiotic or antiviral treatment
For Group 3 (suspected MDR-TB patients):
• Previous history of treatment for MDR-TB or extensive drug resistance TB (XDR-TB)
• Current or previous participation in any investigational drug or medical device study in the past 3
months
• Patients on any concomitant antibiotic or antiviral treatment |
80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
18 Year(s) |
80 Year(s) |
Both |