IVD clinical performance studies
A diagnostic test is only as credible as the evidence behind it. We design and run clinical performance studies for in vitro diagnostic devices to ISO 20916:2019, the international standard for good study practice in IVD performance studies.
What a clinical performance study shows
A clinical performance study measures how well a test identifies or rules out a condition in the people it is intended for. It reports figures such as diagnostic sensitivity, diagnostic specificity and agreement with a reference method.
Regulators ask for this evidence before they register a device, and laboratories ask for it before they buy one.
Study designs we offer
- Diagnostic accuracy studies. Your device compared with a reference standard in the intended-use population.
- Method comparison. Your device compared with an established method, following CLSI EP09.
- Precision studies. Repeatability and reproducibility, following CLSI EP05.
- Qualitative test performance. Positive and negative agreement, following CLSI EP12.
- Studies on leftover or archived specimens. Faster and lower in cost where the intended use allows it.
Specimens and laboratories
We source specimens through qualified partner laboratories and hospital sites, under ethics committee approval and with the consent arrangements each study requires. Every laboratory is assessed before it is used and its work is audited by our quality assurance function.
One study, two regulatory files
A study designed to ISO 20916 can support registration with DRAP and also contribute to the performance evaluation in a CE technical file under EU Regulation 2017/746 (IVDR). Planning for both at the protocol stage avoids paying for the same evidence twice.
Sensitivity and specificity, in one picture
Each dot is one specimen. A clinical performance study compares the test result with the true condition, confirmed by a reference method, and sorts every specimen into one of four groups.
Illustrative example of 100 specimens. Not data from a real study.
- Sensitivity
- 90% 18 of the 20 people with the condition test positive
- Specificity
- 95% 76 of the 80 people without it test negative
- True positive (18)
- False negative (2)
- False positive (4)
- True negative (76)
Step by step
Duration depends on the design and the number of specimens. We give a study-specific timeline in the feasibility assessment.
Product review
We review the intended use, existing evidence and target markets.
Study design
We write the clinical performance study plan and statistical plan.
Approvals
We obtain ethics approval and any regulatory authorisation required.
Testing
Specimens are collected or retrieved, tested and recorded.
Analysis and report
We deliver a clinical performance study report ready for your submission.
Before you commit
Does my device need a clinical performance study for DRAP?
It depends on the device class and the evidence you already hold. We review your file and tell you what DRAP is likely to expect before you commit to a study.
Can data from Pakistan be used outside Pakistan?
Data from a study designed and run to ISO 20916 is intended to be acceptable internationally. Whether a specific regulator accepts it depends on your intended use and their requirements, which we consider when designing the study.
Can you use leftover specimens?
Often, yes. ISO 20916 allows studies on leftover and archived specimens where the design suits the intended use. This usually shortens the study.
Who analyses the data?
Our data team prepares the statistical analysis plan before testing begins and analyses the data after the database is locked.
How the work is governed
- ISO 20916:2019
- CLSI EP05, EP09 and EP12
- EU IVDR 2017/746
- DRAP Medical Devices Rules 2017