Point Of Care Evaluations

Independent, Evidence-Based Diagnostic Validation

Epicentre is a trusted partner for diagnostic and point-of-care test evaluations in South Africa.

We support international manufacturers, research institutions, and public-health agencies by providing independent validation, real-world testing, and regulatory-ready reporting that meet WHO and SAHPRA standards.

Why Work With Epicentre

✔ Entire team GCP-certified

✔ 24 years of research implementation experience

✔ Documentation aligned with WHO / GCLP / SAHPRA standards

✔ Access to diverse stored and prospective samples

✔ Proven track record in rapid and point-of-care evaluations

About Our Point-of-Care Evaluation Services

Epicentre provides end-to-end diagnostic evaluation support from ethical approval and protocol design to testing, analysis, and reporting.

We ensure that every device or rapid test is evaluated under real-world conditions, generating data you can trust for submission, publication, or regulatory review.

Challenges in Diagnostic Evaluation

Developing or validating a diagnostic test can be a complex and costly process.

In South Africa, strict regulatory frameworks, demanding ethics approval processes, and limited sample availability often result in delayed evaluation timelines.

Manufacturers and research partners also face challenges in:

✔ Recruiting representative participants

✔ Collecting high-quality biological samples

✔ Comparing performance against established reference standards

Our Solutions

Epicentre removes these barriers through experience, infrastructure, and agility.

Our team offers:

Streamlined ethics and regulatory submissions

Access to retrospective and prospective samples through our national network and walk-in labs

In-house testing environments for accurate side-by-side comparisons

Qualified laboratory scientists and trained field teams

Transparent communication and milestone-based reporting

Our Services

Epicentre offers a complete range of point-of-care evaluation services. Partners can select a full-service package or specific stages.

Evaluation Services Include:

✔ Prepare and submit ethics applications

✔ Develop study protocols and standard operating procedures

✔ Recruit and train evaluation staff

✔ Recruit participants and collect live or stored samples

✔ Conduct test-performance analysis vs. reference methods

✔ Generate validated evaluation reports ready for sponsor or regulatory submission

Benefits of Partnering With Epicentre

Extensive Experience

Our team brings deep expertise in field and laboratory evaluations — from HIV and TB rapid diagnostics to COVID-19 antigen and antibody tests — providing scientifically sound, actionable data.

Cost-Effective Evaluations

We maintain competitive pricing without compromising rigour or accuracy, leveraging streamlined processes and local partnerships to optimise budgets.

Agile & Responsive

Epicentre’s flexible structure allows us to mobilise quickly, adapt to new protocols, and deliver results on schedule.

We operate with open communication, collaborative project management, and real-time updates to keep partners informed at every stage.

Trusted by Global and Local Health Leaders

Epicentre has partnered with:

These collaborations have validated multiple rapid and molecular diagnostic platforms, now used globally, for detecting HIV, TB, and respiratory diseases.

Contact Our Evaluation Team

📧 research@epicentre.org.za

| 📞 +27 31 880 2150 | 💬 WhatsApp 072 843 7564

📍 Durban | Cape Town | Johannesburg