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A study to compare a new test for Tb with current methods.

Side by Side comparison and evaluation of AmpEZ Real Time MTB Test with standard cultural and molecular methods.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/06/014487
Enrollment
2000
Registered
2018-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients showing signs and symptoms of pulmonary TB. Health Condition 2: A159- Respiratory tuberculosis unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: standard MGIT/LJ culture: AmpEZ Real time MTB LAMP assay will be compared with standard MTB MGITLJ culture. Control Intervention2: GenXpert: AmpEZ Real t

Sponsors

AmpliGene India Biotech Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with signs and symptoms of pulmonary TB between the age of 18-75 years to be included in the study.

Exclusion criteria

Exclusion criteria: Patients will be excluded if they are below 18years, or not willing to give consent, or are taking tuberculosis treatment for last 10 days.

Design outcomes

Primary

MeasureTime frame
Establishment of study sites,recruitment of cases/patients.Timepoint: Study centers - 3 to 6 months Recruitment - continuous process—

Secondary

MeasureTime frame
clinical performance evaluation.Timepoint: March 2018—

Countries

India

Contacts

Public ContactDr Chirag Pandya

AmpliGene India Biotech Pvt. Ltd

chiragrpandya@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026