Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Report of an Expert Consultation on the Uses of Nucleic Acid Amplification Tests for the Diagnosis of Tuberculosis

Report
Report of an Expert Consultation on the Uses of Nucleic Acid Amplification Tests for the Diagnosis of Tuberculosis

This report on the uses of nucleic acid amplification (NAA) tests for diagnosis of TB is based on contributions of an expert panel of consultants convened by the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL). The report presents the background for the study; general considerations, such as optimum patient care and public health, the value of NAA testing for clinicians and TB control officials, limitations of the tests, costs and funding issues, and turnaround time; research needs; available information on molecular drug susceptibility tests; the general recommendations of the panel; the communication plan for the new recommendations; and recommendations to the Advisory Council for the Elimination of TB (ACET), CDC, and the Division of TB Elimination (DTBE). The recommendations included the following: that all U.S. clinicians and public health TB programs should have access to molecular tests to aid in the diagnosis of TB and that NAA testing for TB should become standard practice for TB suspects.

Topic:

TB

Country of Origin:

United States

View Webpage

Related Materials

Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis

This report presents the Centers for Disease Control and Prevention's (CDC) updated recommendations on the use of nucleic acid amplification tests (NAA) for TB diagnosis. These revised guidelines were developed on the basis of a report by a panel of clinicians, laboratorians, and TB control officials. The panel was convened by CDC and the Association of Public Health Laboratories (APHL) and in consultation with the Advisory Council for the Elimination of TB (ACET). The report recommends that NAA testing be performed on at least one respiratory specimen from each patient with signs and symptoms of pulmonary TB for whom a diagnosis of TB is being considered but has not yet been established and for whom the test result would alter case management or TB control activities. A revised testing and interpretation algorithm is proposed.

Report

MMWR: Nucleic Acid Amplification Tests for Tuberculosis

This report summarizes potential uses of nucleic acid amplification (NAA) tests such as the Amplified Mycobacterium Tuberculosis Direct Test (MTD) for TB diagnosis and provides interim guidelines for the use of such tests. The report lists the current NAA tests, their FDA approved uses, their non-approved indications also known as off-label uses, limitations, and cautions.

Report

MMWR: Update: Nucleic Acid Amplification Tests for Tuberculosis

This notice explains that on September 30, 1999, the Food and Drug Administration approved a reformulated amplified Mycobacterium Tuberculosis Direct (MTD) test for detection of Mycobacterium tuberculosis in acid-fast Bacille (AFB) smear-positive and smear-negative respiratory specimens from patients suspected of having TB.

Report

Global resources for the prevention,
management, and elimination of TB.