Diagnostic Product Testing & Validation | Epicentre Health Research South Africa
For IVD manufacturers & research organisations

Independent Diagnostic Product Testing in South Africa

We help diagnostic manufacturers validate their products for regulatory submission. WHO-aligned methods, GCP-certified team, SAHPRA-ready reports.

This service is for diagnostic product manufacturers. We do not run patient trials or accept public sign-ups.

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24+
Years' experience
65+
Peer-reviewed publications
9
Provinces covered
100%
GCP-certified team
Research partners:
Why Epicentre

We Remove the Barriers That Delay Diagnostic Validation in South Africa

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Streamlined Ethics & Regulatory

Fast-track ethics submissions with established relationships at South African Research Ethics Committees. SAHPRA-aligned documentation from day one.

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Diverse Sample Access

Archived stored samples and field-based sourcing through our national laboratory network across all 9 provinces. Demographically representative of South Africa's population.

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GCP-Certified Team

Every team member holds current Good Clinical Practice certification. Our laboratory staff are trained in GCLP and ISO 15189 requirements.

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Regulatory-Ready Reports

Deliverables formatted for SAHPRA registration, WHO prequalification, and CE marking dossiers. Statistical analysis using WHO-standard methods.

Our Services

Full-Service or Modular Support at Every Stage

End-to-end diagnostic validation support – from ethics approval and method design to testing, analysis, and regulatory reporting. Select a full-service package or engage us for specific stages.

01

Ethics & Method Design

Prepare and submit ethics applications. Design testing methods aligned with WHO guidance and SAHPRA requirements. Develop SOPs and data collection tools.

02

Staff & Site Preparation

GCP/GCLP training for all testing personnel. Set up testing stations with quality controls. Verify equipment calibration and supply chain.

03

Sample Sourcing & Logistics

Access archived stored samples or source field-based specimens through our national laboratory network. Cold chain management and sample tracking included.

04

Testing & Reference Comparison

Run your device alongside reference methods under controlled conditions. Blinded testing, real-time quality monitoring, and anomaly resolution.

05

Analysis & Validation

Sensitivity, specificity, PPV, NPV, and agreement statistics. Sub-group analysis by demographics, disease stage, and sample type.

06

Regulatory Reporting

Performance evaluation reports formatted for SAHPRA, WHO prequalification, and CE marking. Publication-ready manuscripts for peer review.

Expertise

Disease Area Experience

Validated experience across priority infectious diseases in South Africa.

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HIV

RDTs, NATs, viral load

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Tuberculosis

Molecular, antigen

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COVID-19

Ag, Ab, PCR

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Respiratory

RSV, flu, multiplex

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STIs

Syphilis, HBV, HCV

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Other IDs

Malaria, cholera

Quality

Quality & Compliance Standards

Every project aligned with international requirements.

WHO Methods

Standardised testing methods per WHO prequalification requirements.

GCP / GCLP

Good Clinical Practice and Good Clinical Laboratory Practice certified.

SAHPRA

South African regulatory requirements for IVD registration.

ISO 15189

Medical laboratory quality and competence standard.

Infrastructure

Specimen Access Across South Africa

Through our national laboratory network and walk-in branches, we provide access to diverse stored and field-sourced specimens representing South Africa's population demographics and disease prevalence.

Serum Plasma Whole blood DBS Nasopharyngeal swabs Urine Stool Vaginal swabs
Discuss Specimen Requirements
Process

How Our Testing Process Works

A transparent, milestone-based approach from scoping to final deliverables.

1

Scoping & Proposal

We review your device, target claims, and regulatory pathway. You receive a detailed proposal with timeline, specimen requirements, and pricing.

1 – 2 weeks
2

Ethics Approval

We prepare and submit ethics applications to the appropriate Research Ethics Committee. Our established relationships help expedite approvals.

4 – 8 weeks
3

Specimen Sourcing

We source the required specimens – archived stored samples, field-based collection, or a combination – matched to your device's intended use.

2 – 12 weeks
4

Testing & Analysis

Blinded testing of your device against reference methods. Real-time quality monitoring, statistical analysis, and sub-group breakdowns.

2 – 8 weeks
5

Draft Report Review

You review the draft performance report. We incorporate your feedback and prepare the final regulatory-ready deliverable.

1 – 2 weeks
6

Final Deliverables

Performance report formatted for SAHPRA, WHO prequalification, and/or CE marking. Publication-ready manuscripts available on request.

1 week
FAQ

Frequently Asked Questions

We test a wide range of point-of-care and in vitro diagnostic products including rapid diagnostic tests (RDTs), molecular/nucleic acid tests (NATs), antigen tests, antibody tests, and lateral flow assays. We have particular expertise in HIV, TB, COVID-19, respiratory pathogens, STIs, and other infectious disease diagnostics.
All testing follows WHO standardised methods, Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), and SAHPRA requirements. Our reports support regulatory submissions including SAHPRA registration, WHO prequalification, and CE marking dossiers.
Timeline depends on scope, specimen requirements, and ethics approval. A standard project with field-based specimen sourcing typically takes 3 – 6 months. Projects using archived stored samples or expedited ethics may be faster. We provide detailed timelines during scoping.
Yes. We maintain access to diverse archived stored specimens and can source field-based specimens through our national laboratory network across all 9 provinces and our walk-in labs in Durban, Cape Town, and Johannesburg. Specimen types include serum, plasma, whole blood, DBS, nasopharyngeal swabs, urine, stool, and vaginal swabs.
Yes. Our testing reports are designed to meet WHO prequalification requirements. We follow WHO standardised methods and can coordinate with WHO-listed performance testing laboratories. Our team has extensive experience supporting prequalification submissions.
Our full-service package includes ethics application and approval, method design and SOP development, staff training, specimen sourcing, index test and reference testing, statistical analysis, performance report drafting, and regulatory-ready deliverables. We can also support manuscript preparation for peer-reviewed publication.
Epicentre operates testing facilities and walk-in laboratories in Durban (Head Office, Hillcrest), Cape Town (Observatory), and Johannesburg (Parktown North). Our national field network enables specimen sourcing across all 9 South African provinces.
Epicentre has 24+ years of research implementation experience and has partnered with CDC/PEPFAR, WHO, FIND, CAPRISA, NICD, and major diagnostic manufacturers. Our work has validated multiple rapid tests that have received WHO prequalification and SAHPRA registration. We have 65+ peer-reviewed publications.

Ready to Validate Your Diagnostic Product?

Contact our team for a no-obligation consultation. We will review your device, discuss regulatory pathways, and provide a detailed proposal.

Request a Proposal Download Capabilities PDF
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This service is for IVD manufacturers and research organisations. Epicentre does not run patient trials, accept public sign-ups, or offer experimental treatments.
Request a Proposal Capabilities PDF