Tools for COVID-19 Diagnostic Development and Application

Resources provided by Halteres Associates to our clients and constituents to assist them in developing or identifying the best products to fill specific market needs

Since the outbreak of COVID-19, we have been preparing a series of newsletters providing information about SARS-CoV-2 medical tests. We began with a description of Use Cases and their implications for test design. We followed with a set of Use Case tables with detailed information about the intended uses for each Use Case, the performance requirements that might be involved, along with issues and challenges we foresee. This material is one component of the process that we have typically used over many years in the design of diagnostic products that create both clinical and economic value.

On these pages, we present additional tools that may assist product developers in the COVID-19 space (see Use Scenarios (Storyboards)) as well as a discussion of the broader context for how all these tools can be leveraged in diagnostic product development (Value Creation Roadmap).

We hope you find these tools valuable, and we look forward to receiving your feedback as well as interacting with you in the implementation of these tools in your own product development efforts.

Which Use Cases go with which Storyboards?

The Use Cases and Storyboards are complementary to each other (intended use and settings). In some cases an individual Storyboard is very similar to another one, which has only been modified slightly to serve another Use Case. For instance, on-site triage testing is represented in Storyboard A, which was then modified slightly to create Storyboard C for on-site testing for diagnosis (where no confirmation testing is required).  Storyboard A was then modified slightly once again to create Storyboard E for differential diagnosis. The situation is similar for Storyboards B, D, and F, which show off-site testing for confirmation testing for a triage result, diagnosis, and differential diagnosis. The table below provides the relationship between the updated Use Cases and the Storyboards.

Use Case Intended Use Storyboard
(on-site testing)
(off-site testing)
1 Triage/Confirmation of Symptomatic Persons in Epidemic Setting A Not applicable
2 Triage/Confirmation of Symptomatic Persons in Endemic Setting A Not applicable
3 Triage/Confirmation of Non-Symptomatic Persons in Epidemic Setting H* Not applicable
4 Confirmation of Triage Testing A B
5 Diagnosis C D, I
6 Differential Diagnosis E F, I
7 Previous Exposure H G, I
8 Surveillance** Not applicable G, I
9 Environmental Testing Not shown Not shown
10 Health Checks and Health Surveys H, I Not applicable
11 Screening of Non-Symptomatic Persons** H I

*We did not include a separate Storyboard for Use Case 3, but it would be consistent with H.

**Surveillance (populations) and Helath Screens (individuals) could be conducted with tests associated with three Use Cases: 5, 6 and 7 

Value Creation Roadmap for Developers

Test User Roadmap

Use Case Definitions

Use Scenarios (Storyboards)

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