Case Study

Cepheid – Global Laboratory Initiative

Company Cepheid, United States
Sub category of Industry Diagnostics
Category of commitment Access
Which product(s) Diagnostics
Key focus Strategy
Key partners of the program Global stakeholders i.e. WHO, access initiatives, international NGOs, International organizations (e.g. WHO, international NGOs), NGOs
Geographic focus Global

Health needs

WHO’s global strategy for tuberculosis (TB) prevention, care and control for 2015–2035 (known as the End TB Strategy) calls for the early diagnosis of TB and universal drug-susceptibility testing (DST), highlighting the critical role of laboratories in the strategy.

Initiative’s objective

Create a framework of testing algorithms in line with the goals of the End TB strategy and incorporate the recent WHO recommendations for tests to detect MTB (TB-LAMP, LF-LAM) and detect drug resistance (first- and second-line LPAs).

Initiative’s description

Laboratories play a crucial role in identifying early active cases of Tuberculosis (TB), which is a key to eliminating the disease worldwide. In order to meet WHO’s goals for prevention of TB transmission and improvement of patient care, rapid testing of TB suspects with sensitive molecular diagnostic tests is recommended by the Global Laboratory Initiative (GLI) and experts from the European Tuberculosis Laboratory Initiative (WHO European Region). Both global expert groups recommend the use of Cepheid’s Xpert MTB/RIF as a frontline test, rather than smear microscopy or line probe assays in conjunction with culture-based methods for drug susceptibility testing.

Lessons for success

The following points should be considered when designing or reviewing algorithms for
testing at different levels of the laboratory network:

  • The specific diagnostic tests in use or being considered for use;
  • Whether, and for what purposes, the tests are recommended by WHO;
  • The current and planned capacity of the country’s laboratories, the laboratory
    infrastructure, and the availability of competent personnel to conduct the tests;
  • The adequacy of systems for specimen collection and transport, and the average
    turnaround time between sites;
  • The capacity of clinical services to offer diagnosis and treatment;
  • Which drugs are used for the treatment of TB; and
  • Characteristics (risk groups) of the population being served, which should be derived
    from population-based studies (if available), including the proportion with drug-
    resistant TB, the proportion that is HIV-positive, the proportion with extrapulmonary
    TB, and the proportion that is among children.