Table 1

Minimal and optimal target product profile characteristics focused on the general scope of the toolkit and toolkit component characteristics, as defined by expert consensus process

General Scope
CharacteristicsMinimal requirementsOptimal requirementsComments
Intended useThe toolkit, composed of an electronic clinical decision support algorithm(s) and POC diagnostic tests, is intended to increase evidence-based treatment decisions by capturing diagnostic test results, patient clinical data (eg, exposures, signs including vital signs) and context-specific data (eg, disease incidence, seasonality) to provide treatment and care recommendations
Target populationThe algorithm shall define the target population
Inclusion and exclusion criteria are used at the encounter to enrol the patient
The system can be modular, that is, composed of discrete algorithms, such that one can be used for a specific population based on predefined criteria
Setting (level of implementation in the healthcare system)Defined by the algorithmThe system can be modular, that is, composed of discrete algorithms, such that one can be used for a specific healthcare setting based on the infrastructure, workforce knowledge and skills, and POC tools available
Targeted end userDefined by the algorithmThe end user shall have the required training/skills to use the app appropriately
Scope of toolkit components
Algorithm accessThe electronic clinical decision support algorithm is accessible through an app downloaded on compatible target devicesThe app can be a web app, a native app or a hybrid app
Algorithm contentBuilt on:
  •  Well-established clinical evidence based on WHO/international/local clinical care guidelines, peer-reviewed articles (systematic reviews, original clinical research) and clinical experience/practice

  • And/or appropriate clinical validation research*

*See FDA’s SaMD clinical evaluation for guidance20
Algorithm treatment recommendationsTherapeutic recommendations shall be compliant with national treatment guidelines and national EML, and support antimicrobial stewardshipSame as minimal, and evidence-based medicine to support optimal treatment recommendationsRecommendations support the appropriate selection, dosage and duration of antimicrobial and any other kind of treatment and management, causing the least harm to the patient
Compatible POC toolsPOCs or other relevant medical devices prompted for use by the app shall be locally relevant, that is, recommended by EDL or relevant national equivalent or country programmeSame as minimal, plus emerging diagnostic tools and medical devices relevant to the algorithm and implementation setting
Regulated toolkit componentsPOC diagnostic tests and medical devices are regulatory approved and compliant with local regulationsSame as minimal, and if the software is a medical device the app shall also have regulatory approval
Compatible devicesThe app is compatible with any device, including:
  •  Smartphones

  •  Tablets

  •  Computers

Computers are included as it may be necessary for health facility supervisors to access data collected at the facility level to make informed decisions (ie, restocking medical supplies)
Compatible operating systemsOS agnosticSame as minimal
  • EDL, Essential Diagnostics List; EML, Essential Medicines List; FDA, Food and Drug Administration; OS, operating system; POC, point-of-care; SaMD, software as a medical device.