Tuberculosis
Conditions
Interventions
Consist in the Line Probe Assay (LAP) diagnostic test evaluation on sputum samples, from participants with drug-resistant tuberculosis (TB-DR), multidrug-resistant tuberculosis (TB-MDR) and tuberculos
Sponsors
Programa Nacional de Controle da Tuberculose CGPNCT / DEVIT Secretaria de Vigilância em Saúde/Ministério da Saúde
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinical sample from patients with probable drug-resistant pulmonary tuberculosis (TB) according to Brazilian Ministry of Health Standards; Xpert MTB/RIF test positive to sputum sample submitted to LPA-1 test and routine diagnostic procedures (culture and antimicrobial susceptibility test in liquid medium); Sample from patient who has not received treatment regimen for TB sensitive drug or TB-DR/MDR for more than 7 days of the past 30 days; Sample from subject with HIV serological test (positive or negative; if the last documented negative HIV test was performed more than three months before the screening visit, the current serological status should be assessed); Sample from subject aged 18 years or older; Samples from subject with a Karnofsky score of 60 or greater at screening; Subject able to provide their consent by signing in the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Samples from patients unwilling to take an HIV test if there is no documented HIV test result within three month; Samples from patients deprived of their liberty; Samples from patients whose Information about whether or not to start anti-TB treatment is not present in the medical records / forms of the participating Health Units or in the notification form; Lung samples with a positive result by Xpert MTB / RIF, in which culture or TS were not performed; Samples from patients with inconclusive results on the LPA1 and /or LPA2 tests; Samples from patients with Mycobacterium tuberculosis (MBT) isolates that do not grow or contaminate in the TS and those identified as non-tuberculous mycobacteria (NTM)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimate the diagnostic accuracy of the LPA-1 test to detect resistance to rifampicin (RIF) and isoniazid (INH) among individuals submitted to TB-DR or sensitive investigation, using phenotypic drug susceptibility testing (DST). ;Compare the diagnostic accuracy of the LPA-1 test with the gold standard, the phenotypic DST, for the detection of RIF resistance.;Assess the diagnostic accuracy of LPA-1 tests in the diagnosis of INH resistance, using phenotypic DST as the gold standard;Assess the diagnostic accuracy of LPA-2 tests in the diagnosis of resistance to capreomycin, amikacin and fluoroquinolones using phenotypic DST as the gold standard | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the time elapsed between screening until detection of TB resistant to RIF and TB- MDR, using the result release date in the Laboratory Environment Manager ;Assess the time elapsed between the detection of TB resistant to RIF and MDR-TB, and the begginning of the appropriate treatment;Evaluate the principal difficulties and the facilities to implement a quality system in the participants laboratories, using five indicators to medium and long terms. | — |
Countries
Brazil
Contacts
Public ContactAfrânio Kritski
Faculdade de Medicina da Universidade Federal do Rio de Janeiro
Outcome results
None listed