What are Target Product Profiles

As mentioned in a previous blog, Target Product Profiles (TPPs) have been producted to help advise and guide manufacturers who aim to deliver lateral flow tests into the UK.

While th Target product Profiles are a guide. Failing to reach the criteria does not mean that the test isnt suitable at all for the UK market.

While science is evolving all the time. The TPP are naturally subject to review.

The purpose of a Target Product Profile (TPP) provide the ‘profile’ of a target product that is aimed at a particular pathogen or disease.

The TPPs state intended use, who are the target populations and other desired attributes of products. Such as safety and performance-related characteristics.

There is enough detail to allow lateral flow test developers and key stakeholders to understand the characteristics a test must have to be successful for the particular intended use.

What does this include: a description of (1) the preferred (2) :the minimally acceptable profiles based on the intended use, :setting of use :intended user, with respect to the performance characteristics expected of the target products. As new scientific evidence is generated, this TPP may require further review and revision.

How closely a product matches the TPP profile may inform Government procurement and decision making around regulation.

Any deviation from existing standards must be fully justified.

While Production lead time of the lateral flow tests may also factor into decision making.

The Testing Strategy

The testing strategy will be enhanced by parallel testing capability offered through the availability of point of care tests that can detect the SARs-CoV-2 virus in a near patient setting quickly.

Giving care professionals to efficiently triage patients depending on their likelihood of being infected.

Such tests require taking a small sample of bodily fluid and looking for the presence of viral nucleic acids or antigens specific to SARS-CoV-2, the causative agent of COVID-19.

When available these lateral flow tests could be used across the broad spectrum of health and care settings and eventually in a range of contexts. Including: schools, airports and prisons.

The lateral flow tests need to be safe, simple, robust and have a rapid time to test result.

Not part of the profile but might include:

• to provide a confirmatory diagnosis of patient’s current Covid 19 infection status
• to give guidance on a patient’s likely outcome. Such as disease severity or survival
• to predict or monitor a patient’s likely response to treatment

to differentially diagnose Covid 19 from other common febrile or flu like disease pathogens. By the use of a multiplex assays rapid laboratory tests to augment clinical laboratory capacity and turn around time self-tests to be performed by a lay individual

Each of these organisations has extensive experience with establishing TPPs for simple, rapid diagnostic tests.

World Health Organisation Target Product Profiles.

Find uses the world health organisation TPP:

FIND contributed to the world health organisation target product profiles (TPPs) for priority COVID-19 diagnostics.

The WHO TPP define what is acceptable.

Point of care test for suspected COVID-19 cases and their close contacts to diagnose acute Covid 19 infection in areas where reference assay testing is unavailable, or turnaround times means clinical utility isnt available.

Test for diagnosis or confirmation of acute or sub acute Covid 19 infection, suitable for low or high-volume needs

Point of care test for prior infection with Coivd Test for prior infection with Covid-19 for moderate to high volume needs