Table 1 Summary of frameworks used in the development of TPPs and an overview of criteria used to select TPP features and their target levels according to appropriate criteria for product types. Abbreviations WHO: World Health Organization, TPP: target product profile, ICH: International Council for Harmonization, FDA: Federal Food and Drug Administration, FIND: Foundation for Innovative New Diagnostics, MSF: Médecins sans Frontières, HIV: human immunodeficiency virus

ICH Q8 (R2).

14

[35, 50, 72, 73, 83, 102, 106, 113, 121, 127, 146,147,148, 152]

FIND TPPs.

7

[58, 62, 87, 100, 106, 119, 127]

WHO TPP.

4

[28, 87, 119, 142]

FDA guidance.

2

[50, 103]

TPP for dual HIV/syphilis tests commissioned in 2013 by UNITAID.

1

[25]

Previously published TPPs.

1

[28]

Published standards and guidelines, input from interviews.

1

[58]

Based on regulatory and practical considerations and limitations.

1

[75]

Own strategic framework, including two complementary TPPs: Target Market Profile (TMP) and Strategic Target Profile (STP).

1

[84]

MSF TPPs.

1

[142]

Own framework for discussion in regulatory and guideline development contexts.

1

[148]

Criteria to select features

Literature review.

10

[31, 61, 62, 70, 72, 86, 93, 100, 128, 151]

Consensus agreement by a certain agreed percentage.

4

[87, 100, 119, 142]

Existing knowledge.

4

[32, 74, 83, 128]

Diagnostic accuracy parameters based on reference tests.

2

[64, 66]

Systematic review, published predictive models, landscape analysis.

1

[25]

Expert opinion.

1

[58]

Based on the requirements of the interested parties (clinical expectations, patients’ and industrial needs, regulatory aspects).

1

[114]