Solution for quick and accurate processing of PCR tests

We created a solution that enables fast PCR testing outside of healthcare settings, delivering accurate and reliable results.

Client and challenge

Our client is a dynamic point-of-care diagnostics company based in Belgium. With an extensive portfolio of tests for the screening, diagnosis, and monitoring of a wide range of health conditions, the company is revolutionizing diagnostics by reinventing high-precision liquid control and ultra-fast PCR using innovative silicon chip technology.

When the COVID-19 pandemic hit, requiring rapid and accurate PCR testing at on-demand locations, the client launched the development of a molecular diagnostic pipeline using its own ultrafast PCR technology.

Specialists on the client’s side created a proprietary algorithm to detect the virus in a sample. The next step in the development was an algorithm-based diagnostic platform. The solution needed to combine software, hardware (including readers and PCs), and reader firmware, all communicating with each other.

The engineers at EffectiveSoft had already helped the client develop a hardware testing solution. In the next phase of the project, our specialists were asked to develop a Windows-based application to connect the hardware with the algorithm, along with a user interface (UI).

Client
Point-of-care diagnostics company
Country
Belgium
Domain
Healthcare
Solution
Windows-based application
Outsourcing model
Staff augmentation
Technology
Windows 10 Pro, .NET 5.0, WinUI

Solution

Cooperating closely with the client’s in-house specialists, we created:

A hardware simulator that enabled early software development alongside the ongoing hardware design process.
A Windows service (and subsequently a Windows application) for managing the PCR process.
Smooth user experience for the whole system.
A communication protocol for data transmission within the system.

The solution components were integrated into a single platform. The evaluation performed by the client’s in-house QA team showed that the functionality and performance met CE-IVD certification criteria and were launch-ready.

The PCR testing solution consists of three key components:

Hardware. A PCR reader uses PCR cards to perform ultrafast testing through thermocycling and optical detection.
POC. A point-of-care (POC) device connected to a PCR reader. The device is used by medical personnel at on-demand locations.
Software. A user-friendly Windows platform with a communication protocol between system components. The platform manages the PCR process, allowing users to supervise the whole system.

The PCR testing process supported by our solution is accurate and simple for end users:

In close collaboration with the client, we created a powerful solution for PCR testing

Usability testing

To enhance the user experience for the point-of-care solution, we continuously tested the sample testing flow with a focus group. Our goal was to minimize the number of screen touches and streamline the operator’s workflow for maximum efficiency.

Brainstorming sessions

We joined our forces to successfully overcome all the challenges in our way and create a valuable product. By sharing ideas, our teams explored new approaches to problem-solving and found effective solutions.

On-site collaboration

On-site work allowed our engineers to meet the client’s team and perform real tests on the hardware in a laboratory. This helped our team understand the business environment and goals, accelerated product development, and enhanced the solution.

Healthcare Software Development

EffectiveSoft leverages over 15 years of practical experience in providing healthcare software development for medical facilities. With our healthcare software outsourcing services, we help caregivers manage all kinds of complex data and contend with everyday issues on their way to improved patient outcomes.

Result

The EffectiveSoft team successfully completed the development of the complex product in cooperation with the client’s development and testing teams. The Windows-based solution, incorporating the client’s unique algorithm, complies with customer requirements, domain legal requirements, and IEC 62304. The solution architecture allows the addition of new protocols to test other diseases.

This is a significant leap for diagnostics, making it fast and reliable. And our team is proud to be a part of its creation.