Targeted NGS (tNGS) Solutions kit Evaluation for Diagnosis of Drug Resistant TB

Not Applicable

Conditions: Health Condition 1: J709- Respiratory conditions due to unspecified external agent

Registration Number: CTRI/2019/11/021973

Lead Sponsor: Foundation for Innovative New Diagnostics FIND

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. A clear TB-positive result by Xpert MTB/RIF OR Xpert MTB/RIF Ultra prior to enrolment, irrespective of RIF-resistance status,

AND

2.At risk for drug resistant TB based on at least one of the following risk factors:

A.Not responding TB treatment with positive sputum smear or culture after >= 3 months of standard TB treatment.

B.Previously diagnosed with Rif-resistant/MDR-TB and failed TB treatment with positive sputum smear or culture after >= 3months of a standard MDR-TB regiment

C.Previously received >1 month of treatment for a prior TB episode

D.Close contact with a known drug-resistant TB case

AND

3.Willing to provide sputum

AND

4.Over 18 years of age (or legal adult age corresponding to the site)

5.Provision of signed informed consent

Exclusion Criteria

1.Have started treatment for current TB episode more than 7 days prior to date of enrolment (i.e. must have been on treatment for less than 7 days for this TB treatment episode at enrolment)

2.Are pregnant or institutionalized or imprisoned

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Point estimates, with 95% confidence intervals, of sensitivity and specificity for rifampicin, isoniazid, fluoroquinolones, second-line injectables, and pyrazinamide resistance detection for up to 3 tNGS solutionsTimepoint: Sputum samples will be collected from patient on the day of enrolment and the following day (Day 1 and Day 2) and pooled together to generate sediment. Frozen sediments will be processed using end-to-end targeted sequencing solutions no later than 1 month after collection.

Secondary Outcome Measures

Name	Time	Method
1.Detecting sensitivity and specificity (95%) for second-line resistance detection (bedaquiline, linezolid, clofazamine, streptomycin). <br/ ><br>2.Performance of overall test success rate against Xpert MTB/RIF and Hain MTBDRplus/sl. <br/ ><br>3.Performance characteristics including invalid and indeterminate rates, ease of use metrics, and other operational characteristics. <br/ ><br>Timepoint: 12 months