4.1 Peripheral level
At the peripheral level (Level I), laboratories offer a range of basic diagnostic tests, with the focus being on providing initial testing to rapidly detect TB (and RIF resistance):
TB KaSPar
At the peripheral level (Level I), laboratories offer a range of basic diagnostic tests, with the focus being on providing initial testing to rapidly detect TB (and RIF resistance):
The desired outcomes from diagnostic tests that are implemented are that the test should:
Health needs are diverse, and programmes are expected to provide a range of diagnostics to assist health workers in managing patients as effectively and efficiently as possible. The diagnosis of TB often begins with assessing symptoms; this is not specific to TB, given that cough and fever overlap with COVID-19 and other respiratory infections. Additionally, people with TB may also have HIV, and services for both diseases are usually provided at the same levels of care.
3.5.1 What are the advantages and disadvantages of testing for TB infection?
The use of an mWRD as the initial test to diagnose TB greatly increases the sensitivity of the diagnostic process compared with the use of sputum smear microscopy (57). However, certain subpopulations will not fully benefit from the high sensitivity of the molecular tests. For example, people living with HIV, especially those who are seriously ill, are known to have difficulties producing sputum; similarly, children, especially those aged below 5 years, often cannot easily produce sputum.
As part of a wider quality management system (QMS) for testing services, quality assurance (QA) is defined as a set of planned and systematic activities to ensure that organizational quality requirements are met; this enables laboratories to maintain accuracy, reliability and reproducibility of results.
The predictive values of a test vary depending on the prevalence of TB in the population being tested. The prevalence of TB in a country is best estimated through a national TB prevalence survey. Countries should conduct prevalence surveys about every 10 years. If a survey has not been conducted recently, WHO provides estimates of prevalence in its annual global TB report (2). These estimates are based on the number of notified TB cases submitted each year by Member States.
In selecting a diagnostic test to implement, it is important to consider the characteristics (i.e. risk factors) of the population being served. These characteristics should be derived from population-based studies, if available, and should include the proportion of:
Based on reviews of available data, WHO has recommended against using tests that do not provide reliable information for diagnosing TB.