Evaluation of the QuantiFERON-TB Test.

QIAGEN Gaithersburg, Inc33 enrolled

Overview

To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

The objective of the study was to enroll patients who have clinical signs/symptoms strongly indicating TB and who are receiving of have to start the treatment for active TB, and test the variants of the CST001 assay to support the evaluation of clinical sensitivity.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Tuberculosis

Interventions

CST001DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical symptoms consistent with a high probability of having TB disease * Receiving, or are likely to receive, therapy for active TB * Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing. * Between 18 and 70 years of age. Exclusion Criteria: * Taken therapy for active TB or latent TB for more than 14 days * Culture confirmation of M. tuberculosis not obtained

Locations (1)

University of Southern California

Los Angeles, California, United States

Outcomes

Primary Outcomes

Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity

To evaluate the clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms strongly indicating TB disease and who are receiving or have to start treatment for active TB, and whom Mycobacterium tuberculosis (MTB) is confirmed by bacteriological culture. Patients included in the testing either had a positive acid-fast bacillus (AFB) smear of have MTB in a specimen detected by nucleic acid amplification (NAA) of MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment.

Time frame: At time of enrollment

Data from ClinicalTrials.gov

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