Diagnoses Disease, Tuberculosis
Conditions
Brief summary
Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU).
Detailed description
STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay which detects lipoarabinomannan in human urine sample. The test evaluated in this study may provide benefits for the development of non sputum-based, less invasive tuberculosis diagnostics that include easier to collect biological samples. The study can therefore be relevant for updating WHO guidelines for TB diagnosis. The results of the STANDARDTM F TB LAM Ag FIA will be interpreted according to the manufacturer´s instructions and will be compared to the results of the test performed to confirm the pulmonary TB, the extrapulmonary TB or the pulmonary NTM diagnosis (intention to treat assay). The test will be repeted at the end of the anti-TB therapy to evaluate if the test can be used as marker of treatment response. Healthy subjects without exposure or risk for TB factors will serve as a proxy for specificity; subjects with confirmed TB will serve as control group to estimate sensitivity.
Interventions
DEVICESTANDARDTM F TB LAM FIA
STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay for the qualitative detection of specific antigen from mycobacterial lipoarabinomannan (LAM) in urine specimen. STANDARDTM F TB LAM Ag FIA should be used with the STANDARD F Analyzers manufactured by SD BIOSENSOR.
Sponsors
Ospedale San Raffaele
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for PTB, PNTM and extraPTB: * Adult subjects with documented active pulmonary TB, pulmonary NTM or extrapulmonary TB * Subjects who have signed informed consent * Aged ≥18 years Inclusion criteria for HC: * healthy donors who have signed informed consent * aged ≥ 18 years * no TB or NTM risk factors or exposure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay | 12 months | STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay for the qualitative detection of specific antigen from mycobacterial lipoarabinomannan (LAM) in urine. The test should be used with the STANDARD F Analyzers manufactured by SD BIOSENSOR that are Europium (Eu) based fluorescent immunoassay system and have been designed for easy and reliable measuring of diverse parameters. The test result of a specimen is given either as Positive or Negative with a COI (cut off index) value. The test may provide benefits for the development of non sputum-based, less invasive tuberculosis diagnostics that include easier-collect biological samples. The results of the test will be compared to the results of the test performed to confirm the pulmonary TB, the extrapulmonary TB or the pulmonary NTM diagnosis Healthy subjects without exposure or risk for TB factors will serve as a proxy for specificity; subjects with confirmed TB will serve as control group to estimate sensitivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects) | 6 months | The test will be repeated at the end of the anti-TB therapy to evaluate if the test can be used as marker of treatment response.We want to evaluate whether, in the face of therapeutic success, the test becomes negative (reversion of results). |
Countries
Italy
Outcome results
None listed