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Rapid Diagnostic Testing at Time of Initial Diagnosis

References in the content below refer to the PBMEF Guide.

Definitions

Percent of people with notified new and relapse TB who were tested using a WHO-recommended diagnostic test (WRD): FluoroType® MTBDR (Hain), Loopamp™ MTBC detection kit (TB-LAMP), Xpert® MTB/RIF, Xpert® MTB/RIF Ultra, Truenat® MTB or MTB Plus, RealTime MTB (Abbott), BD MAX™ MDR-TB, cobas® MTB (Roche), or LF-LAM at the time of initial TB diagnosis (regardless of test result). 

Calculation: (Numerator/Denominator) x 100

Numerator

Number of people with new and relapse TB notified during the reporting period who were tested using a WRD: FluoroType® MTBDR (Hain), Loopamp™ MTBC detection kit (TB-LAMP), Xpert® MTB/RIF, Xpert® MTB/RIF Ultra, Truenat® MTB or MTB Plus, RealTime MTB (Abbott), BD MAX™ MDR-TB, cobas® MTB (Roche), or LF-LAM at the time of initial TB diagnosis (regardless of test result).

Denominator

Number of people with notified new and relapse TB during the reporting period.
Ref #
NEWREL_WRD
(Previously DT-15)
Tier Level
Core Plus Indicator
Category
Reach
Type
Outcome
Unit of Measure
Percent of people
Data Type
Percentage
Disaggregations
Age (0–4, 5–14, 15+)
Sex
Type of diagnostic test
Reporting Level
All Core Plus indicators should be reported at the national level; data may also be collected subnationally for more granular monitoring.
Reporting Frequency
This indicator should be reported on a semiannual basis at a minimum. More frequent monitoring on a quarterly or monthly basis is recommended.

The data sources are the basic management unit TB register and laboratory register at the health facility level and district levels. This is a standard WHO indicator and can be calculated using the WHO Global TB Programme database variable: newinc_rdx (numerator) and c_newinc (denominator)

As countries intensify efforts to improve TB diagnosis and treatment and close the gap between estimated and notified TB, the number and percentage of people with notified TB that are bacteriologically confirmed needs to be monitored to ensure that people are correctly diagnosed and started on the most effective treatment regimen as early as possible. This indicator measures a program’s capacity to detect TB accurately and rapidly using new diagnostics and to increase the percentage of people with TB who are confirmed bacteriologically by scaling up the use of recommended diagnostics that are more sensitive than smear microscopy. The number is also important to monitor for the purposes of estimating procurement needs, especially the disaggregation by type of test.

USAID’s Global TB Strategy sets a goal of 90% of people with incident TB be diagnosed and initiated on treatment with a minimum of 75% of people treated with TB tested with a WHO-recommended rapid molecular diagnostic (mWRD) test in each priority country by 2030. Greater efforts are needed to improve the availability and use of the most sensitive diagnostic tests for TB and to ensure that international standards for TB care are met to avoid missed diagnoses of people who have TB, overtreatment of people who do not have TB, and efficient use of resources.

A high number of people with new and relapse TB notified and tested using a mWRD at the time of TB diagnosis reflects multiple processes, including availability and access to adequate bacteriological diagnostic services (trained staff, equipment, etc.), quality of laboratory testing, and adherence to TB guidelines. This indicator can be compared to the core indicator that measures bacteriological confirmation among all people with notified TB.

As the use of mWRD is expanded to test all people with new diagnoses of pulmonary TB, one should see an increase in bacteriological confirmation over time. By measuring this indicator, countries can track the rollout and use mWRDs. Additionally, this indicator can be compared against national and global standards or targets as a proxy for measuring laboratory performance or capacity within a country.

Additionally, this indicator should be reviewed in conjunction with measurements on the scale of mWRD testing among people with presumptive TB.

Indicator Visualizations

Changelog

January, 2024: Updated the name, definition, and other information based on the Interim PBMEF Tuberculosis Indicator Compendium.