Items tagged with Diagnostics

Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection in United States (document)

This report is aimed at providing guidance to U.S. public health officials, health-care providers, and laboratory workers in the utilization of FDA-approved IGRAs in the diagnosis of M. tuberculosis infection in adults and children. In brief, TSTs and IGRAs (QFT-G, QFT-GIT, and T-Spot) may be used as aids in diagnosing M. tuberculosis infection. They may be used for surveillance purposes and to identify persons likely to benefit from treatment. Additionally, multiple recommendations addressing quality control, test selection, and medical management after testing are provided.

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

These updated guidelines, from a process initiated by the CDC and the Association of Public Health Laboratories (APHL), for the use of nucleic acid amplification (NAA) tests for the diagnosis of tuberculosis (TB) recommend that NAA testing be performed on at least one respiratory specimen from each patient with signs and symptoms of pulmonary TB for whom (a) a diagnosis of TB is being considered but has not yet been established and (b)the test result would alter case management or TB control activities, such as contact investigations.

Technical Guide: Sputum Examination for Tuberculosis by Direct Microscopy in Low-Income Countries (document)

A technical guide for sputum smear microscopy, initiated by the International Union against Tuberculosis, is designed to be an easy to use reference standard for the collection, storage and transport of sputum specimens and for the examination of sputum smears by direct microscopy. This edition includes updates addressing bio-safety and quality assurance aspects of sputum smear microscopy.

Guidance for national tuberculosis and HIV programmes on the management of tuberculosis in HIV-infected children: Recommendations for a public health approach (document)

This guidance document produced by The Union and in partnership with WHO was developed to assist health care workers of national TB and HIV control programs in resource-limited settings in preventing, diagnosing and treating TB in HIV-infected children. Topics covered in the document, as laid out by the Union, include: epidemiology, diagnosis, treatment, special circumstances, prevention, supportive services, infection control and management issues.

Priorities for Bacteriology Services in Low-Income Countries (document)

This guide, known as the “Red Book” dispenses guidance to national officials responsible for reference laboratories on the principal responsibilities such as technical and organisational aspects of smear examination and drug-resistance surveillance.

Use of interferon-gamma release assays in support of TB diagnosis (document)

This report outlines the evidence on IGRAs and their utilization in the diagnosis of latent and active tuberculosis. The document concludes that ‘IGRAs should not replace the standard diagnostic methods for diagnosing active TB.’ It also discusses some clinical circumstances that IGRAs could provide an additional value such as: patients with extrapulmonary TB, patients who test negative for acid-fast bacilli in sputum and/or negative for M. tuberculosis on culture, TB diagnosis in children, or in the differential diagnosis of infection with non-tuberculous mycobacteria.

A Tuberculosis Guide for Specialist Physicians (document)

This document discusses the need for cooperation between tuberculosis control programmes and specialist physicians and the important role of specialist physicians have in an NTP. Each chapter covers critical topics in TB including: epidemiology, pathogenesis, diagnosis, treatment, re-treatment, drug resistance, control, and special populations (HIV, elderly).

Time of great change in TB drug development (post with simple image)

We are living in a time of great change and excitement in TB drug development. The last year has witnessed a number of epochal changes, including the approval and rollout of the most rapid test for TB ever discovered, the GeneXpert; the combination TB drug studies in the relapse mouse model of Eric Nuermberger and Jacques Grosset at Johns Hopkins with support from the TB Alliance; the progression of TMC207 into late phase II and of OPC67683 into phase III; and the first new regimen EBA study, NC-001 also from the Alliance.

TB CAB, TAG open letter to Cepheid (post with simple image)

Re: GeneXpert machine and Xpert MTB/RIF cartridge pricing, extended warranties and business in Russia and the People’s Republic of China

Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults (post with simple image)

A second systematic review of a diagnostic test for TB endorsed by WHO, has confirmed the accuracy of the test. Xpert® MTB/RIF is more accurate than smear microscopy for diagnosing TB and also accurate for detecting rifampicin resistance.

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