1.5. Implementation considerations

Considerations for implementation were as follows:

  • regulatory approval from national regulatory authorities or other relevant bodies is required before implementation of in vivo diagnostic tests;
  • appropriate communication on the new class of tests is necessary, highlighting the difference between the TST and TBSTs;
  • implementation of TBSTs requires a cold chain;
  • well-trained skilled staff are needed to administer and interpret this class of tests;
  • multiuse vials will require effective operational planning and batching; hence, single-use vials or vials with fewer doses to match daily needs are preferred;
  • procurement and stock management aspects will have to be considered, as with implementing any new class of tests; 
  • because the reading of the TBST results requires a second patient visit, linkage to care requires reinforcement, to decrease loss to follow-up;
  • global market availability and necessary volumes of the new class of tests must be considered; and
  • measurement of the TBST reaction size and interpretation must be standardized. 

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