Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests (FIND)

Johns Hopkins University

Status: Completed

Conditions: Tuberculosis

Treatments: Other: Epistem Genedrive® and MolBio Truenat™

Study type: Observational

Funder types: Other

Identifiers

NCT02252198

NA_00085221 (Other Identifier)

Details and patient eligibility

About

Assess sensitivity and specificity of two nucleic acid amplification tests, namely Epistem Genedrive® and MolbioTruenat™ in raw sputum compared to the WHO-endorsed GeneXpert® MTB/RIF assay using a gold standard of four cultures

Full description

• Estimate the accuracy of the Epistem Genedrive® and MolbioTruenat™ in raw sputum and in sputum pellets.
• Assess the operational feasibility of Epistem Genedrive® and MolbioTruenat™
• Determine and compare costs between the Epistem Genedrive®, MolbioTruenat™, and Xpert MTB/RIF tests

Enrollment: 504 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Clinical suspicion of pulmonary TB (including cough ≥2 weeks and at least 1 other symptom typical of TB);

  • Age 18 years or above;
  • Willingness to have a study follow-up visit, if necessary, approximately two months after enrollment
  • Willingness to provide 3 sputum specimens at enrollment
  • Provision of informed consent.

Exclusion criteria

• • Receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment (defined as combination anti-TB therapy intended to treat active TB) within 60 days prior to completion of sputum collection;

  • Inability to provide informed consent (e.g. mentally impaired)
  • Enrolled individuals who do not provide a first sputum sample of ≥ 2ml and a second and third sputum sample of ≥ 1ml each will be classified as early exclusions.

Trial design

504 participants in 1 patient group

Investigational

Description:

• Participants will be asked to provide a total of three sputum samples over Days 1 and 2. The intent is for all samples to be collected before the subject starts any form of TB treatment. The first specimen (S1) should be 2 ml or greater in volume, and the second and third specimens (S2 and S3) should each be 1 ml or greater in volume. On Day 1, each participant will be asked to submit one spot sputum (S1) after enrollment and a second spot sputum after at least 2 hours (S2). Participants will be instructed to come back the following day (Day 2) and provide a third spot sputum (S3). In the event that a participant fails to return on Day 2, S3 may be collected a maximum of 7 days after enrollment, provided that no TB treatment has been initiated.

Treatment:

Other: Epistem Genedrive® and MolBio Truenat™