WHO’s End TB Strategy calls for the early diagnosis of TB and universal drug-susceptibility testing (DST). The WHO assessment process for TB diagnostics currently focuses on evaluating classes of TB diagnostic technologies rather than specific products.
Over the years WHO has developed guidance on multiple technologies, which now need to be consolidated in three classes of NAAT technologies:
- Low complexity automated NAATs (LC-aNAATs) for TB diagnosis and detection of resistance to R+/-H (e.g. Xpert Ultra, TrueNAT, Standard M10, IRON-qPCR, etc).
- Low complexity manual NAATs (LC-mNAATs) for TB diagnosis (e.g.TB-LAMP).
- Moderate complexity automated NAATs (MC-aNAATs) for detection of pre-XDR-TB and XDR-TB (e.g. Bruker-Hain Fluorotype)
WHO aims to evaluate parallel use of NAAT technologies with/without LF-LAM for the diagnosis of TB in pediatric patients and PLHIV as well.
To support this process, WHO is extending a public call for data, appealing to national TB programmes, implementers, industry, researchers, and other agencies to provide suitable evidence on the use of above classes of design-locked marketed diagnostic technologies for diagnosis of pulmonary and extra-pulmonary TB (not limited to the products listed above).
In addition, WHO calls for economic and qualitative data to inform an above-mentioned policy update.
The data will be essential to facilitate the process of WHO policy updates, scheduled for May 2024. Please send relevant data by 15th February 2024, to Alexei Korobitsyn at korobitsyna@who.int.
For more information on the technologies requirements see Annex 1, for parameters of the data for three above mentioned NAATs classes, see the Annex 2 and for parameters of the data for parallel use of NAAT technologies with/without LF-LAM for the diagnosis of pediatric patients and PLHIV, see the Annex 3, for parameters of the economic data see Annex 4, for parameters of the qualitative data see Annex 5.