Mycobacterium tuberculosis infection
Conditions
Interventions
Group 1: Testing of blood samples for Mtb infection with the investigational device.
Group 2: Testing of sputum samples (from the same group) for Mtb infection with the comparator device.
Sponsors
IGDX, Inc. DBA Intelligenome, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Agree with the content and able to sign the Informed Consent Form. Has clinical signs and symptoms typically associated with active TB disease.
Exclusion criteria
Exclusion criteria: Has medical emergency Pregnancy Insufficient physical or mental health condition Having TB treatment for longer than 3 days before enrollment Impaired cognitive function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive Percent Agreement (Diagnostic Sensitivity) Negative Percent Agreement (Diagnostic Specificity) | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive predictive value (PPV), Negative predictive value (NPV), Likelihood ratio (LR) | — |
Countries
Germany
Contacts
Public ContactHakan Inan
Requalite GmbH
Outcome results
None listed