Diagnosis

Diagnosis

Annex 1: Budgetary considerations for implementing a new diagnostic test

Successful implementation of the plan will require financial and human resource commitments from the ministry of health (MoH) or national tuberculosis (TB) programme (NTP), with possible support from implementing partners. Consider integrating TB testing on existing multi-disease platforms in locations where integrated testing is feasible, to share costs across disease programmes. A budget should be developed to address activities in collaboration with key partners, using the considerations outlined below. Technical assistance may be needed.

4.5.1 Implementing a new diagnostic algorithm

Modifications to diagnostic algorithms must be put in place only after a formal evaluation, review and approval by officials within the MoH, NTP and NTRL. Often, nationally appointed thematic working groups are used to evaluate new technologies and develop implementation plans, which typically include revising current algorithms. These groups comprise local ministry officials, implementing partners, civil society and professionals (laboratory and medical), who will decide the optimal use and placement of the new technology within the current network structure.

4.5 Illustrative algorithm combinations

To aid understanding of how the different algorithms interlink to provide a final diagnosis for a patient, illustrative scenarios are presented in Fig. 4.7 to Fig. 4.9.Three scenarios are provided, with two simulated pathways in each. The scenarios are based on three epidemiological settings: high TB/HIV, high Hr-TB and high MDR/RR-TB. These examples are for illustrative purposes only - they do not represent a specific recommendation.

4.4.1 Decision pathway for Algorithm 4

There are two starting points for this algorithm:

• For a patient who has RIF-susceptible TB by DST, detected by either a molecular (e.g. Xpert MTB/RIF, Xpert Ultra or Truenat) or phenotypic test, but no results are available for INH and the patient is at a high risk for Hr-TB, start at Step 1.

• For a patient who has had an initial TB test that included RIF and INH results (e.g. a moderate complexity automated NAAT was used) in Algorithm 1, skip to Step 4.

4.4 Algorithm 4 – mWRD as the initial or follow-on test to detect Hr-TB

Algorithm 4 is for either detection of Hr-TB or follow-on testing for those with Hr-TB already identified. Detection of Hr-TB would be applicable in patients or settings with a high risk for Hr-TB and with RIF-susceptible TB (e.g. those with a molecular WRD result of "MTB detected, RIF resistance not detected") and isoniazid unknown. All patients with RIF-susceptible TB and INH susceptible/unknown should be started on an appropriate first-line regimen, in accordance with national guidelines, while awaiting the results of follow-up testing.

3.4 Multi-disease platform considerations

Health needs are diverse, and programmes are expected to provide a range of diagnostics to assist health workers in managing patients. The diagnosis of TB often begins with symptom screening, which is not specific to TB, given that cough and fever overlap with COVID-19 and other respiratory infections. Additionally, TB patients may be coinfected with HIV, particularly in sub-Saharan Africa, and services for both diseases are usually provided at the same levels of care.

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