Clinical Performance Evidence for IVDs & Diagnostic Devices
Bioexcel supports IVD manufacturers with clinical performance studies, specimen sourcing, prospective and retrospective sample models, comparator/reference testing, layperson studies, EDC, biostatistics and clinical performance reporting.
Our approach is built around the intended purpose of the test and the exact evidence required to demonstrate diagnostic performance.
Does Bioexcel Conduct IVD Clinical Performance Studies?
Yes. Bioexcel supports IVD clinical performance studies including study design, site and specimen feasibility, archived or prospective samples, comparator/reference testing, layperson evaluations, data management, biostatistics and clinical performance reporting.
Bioexcel Lifesciences & Research LLP supports clinical performance evidence programs for IVDs and diagnostic devices, including clinical study design, specimen feasibility and sourcing, prospective sample collection, reference testing, layperson studies, data management, biostatistics and performance reporting.
For dedicated IVD sub-pages on clinical performance studies, specimen sourcing, reference testing and analytical performance, see our full IVD services hub.
Diagnostic Technologies We Can Support
Potential categories:
Infectious Disease
Molecular Diagnostics
Immunodiagnostics
Toxicology
Biomarkers
Self-Testing / Home Use
From Intended Purpose to Performance Conclusion
Intended Purpose
What disease, condition or analyte is being detected?
Target Population
Who will be tested?
Specimen
What sample type is required?
Reference Method
What establishes truth?
Index Test
How is the investigational test performed?
Performance
Sensitivity / specificity / PPA / NPA where appropriate
Clinical Interpretation
Are results clinically meaningful?
IVDR Evidence
CPSR / Performance Evaluation / PMPF
Start With the Exact Diagnostic Claim
- Can the test detect the target condition?
- Can it correctly identify negatives?
- Does performance remain acceptable near the cutoff?
- Does it work across relevant specimen types?
- Does it perform across relevant genotypes/serotypes?
- Can lay users perform the test correctly?
Potential Designs
Collect Samples From New Participants
Potential Advantages
Potential Challenges
Can Bioexcel Conduct Prospective IVD Clinical Performance Studies?
Yes. Bioexcel can support prospective IVD studies through suitable clinical sites with predefined participant criteria, specimen collection, index testing, reference testing, data management, statistics and reporting.
Use Existing Samples When They Are Fit for Purpose
Potential Specimen Types
Assess
Can Bioexcel Conduct IVD Studies Using Archived Samples?
Yes. Bioexcel can assess and support archived-specimen studies when samples have sufficient provenance, characterization, storage history, residual volume and clinical relevance for the intended performance objective.
Check Availability Before Finalizing the Study
A Diagnostic Study Needs the Right Case Mix
- Minimum positive cohort
- Minimum negative cohort
- Disease prevalence considerations
- Prospective vs enriched design
- Relevant clinical controls
The cohort structure should be justified based on the diagnostic claim and statistical precision.
Performance Near the Cutoff Can Be Important
Potential Categories
Can Help Assess
Can Bioexcel Support Weak-Positive Sample Requirements?
Yes. Bioexcel can include weak-positive or near-cutoff specimen requirements in the feasibility strategy where clinically and scientifically relevant to the intended diagnostic performance assessment.
Clinical Performance for High-Complexity Diagnostic Programs
- PCR confirmation
- Antibody/antigen confirmation
- Serotype
- Genotype
- Viral load where relevant
- Cross-reactivity
- Coinfection
- Weak positives
- Disease controls
Potential Study Models
Evidence for Dengue Rapid Tests and Assays
- Dengue-positive specimens
- Dengue-negative specimens
- RT-PCR/NAT confirmation
- NS1
- IgM
- IgG
- Serotype information where available
For Serotype-Specific Studies
Important
NS1 positivity alone should not be treated as equivalent to serotype confirmation unless scientifically justified.
Evidence for Blood-Borne and STI Diagnostics
- Confirmed positive specimens
- Confirmed negatives
- Genotype/subtype where relevant
- Seroconversion panels where applicable
- Cross-reactivity
- Coinfection
- Analytical sensitivity
Potential Reference Methods
Clinical Evidence for PCR / NAAT-Based Assays
Potential Variables
The Reference Method Defines the Performance Framework
The Reference Strategy Should Be Based On
Can Bioexcel Arrange Reference Testing for IVD Studies?
Bioexcel can coordinate suitable reference or comparator testing through appropriate qualified laboratories based on the analyte, study design and scientific requirements.
Clinical Performance for Drug-Screening Devices
Potential Analytes
Potential Reference Methods
Can Bioexcel Support Toxicology IVD Studies With LC-MS/MS or GC-MS?
Yes. Bioexcel can support toxicology clinical performance studies and coordinate appropriate confirmatory reference testing such as LC-MS/MS or GC-MS through qualified laboratories where scientifically required.
Performance in the Intended Clinical Setting
Potential Users
Potential Evidence
Clinical Performance + Layperson Usability
Can the Layperson
- Collect the specimen?
- Run the test?
- Follow the IFU?
- Interpret the result?
- Recognize an invalid test?
And: Is the result clinically correct?
Finger-Prick Self-Tests
- Successful lancet use
- Adequate blood volume
- Sample transfer
- Device operation
- Result interpretation
- Clinical performance
This can combine: Usability, Clinical Performance.
Swab-Based Self-Tests
- Correct sampling
- Extraction
- Timing
- Test operation
- Result interpretation
User error may directly affect clinical performance.
Intended-User Evidence in the Target Market
Can Bioexcel Support Layperson IVD Studies in Europe?
Yes. Bioexcel can support European layperson and self-testing studies through suitable local resources combined with centralized study design, data management, biostatistics and reporting.
Evaluate Performance in Trained Hands
Potential Users
Potential Endpoints
Device + Assay + Reader
Potential Considerations
Clinical Evidence Should Fit With Analytical Evidence
Bioexcel's exact analytical scope should be clearly distinguished from external laboratory testing where applicable.
Challenge the Assay With Clinically Relevant Conditions
The panel should be justified according to the intended test.
Interference
Where required, analytical laboratories may perform controlled interference testing.
Every Test Result Should Trace Back to the Sample
Reduce Interpretation Bias
This is particularly important in diagnostic-performance studies.
Index and Reference Results Will Not Always Agree
Index Positive → Reference Negative → Discordant Result
Potential Next Steps
Important
Do not invent post-hoc rules after seeing the results.
Common Diagnostic Measures
Choice Depends On
Ability to Detect the Target Condition
Sensitivity = True Positives / All Reference PositivesReport with: Estimate, Confidence interval.
Ability to Correctly Identify Negatives
Specificity = True Negatives / All Reference NegativesReport with: Estimate, Confidence interval.
Agreement-Based Measures Where Appropriate
Potential use where the comparator is not treated as a definitive gold standard.
PPA
Positive Percent Agreement
NPA
Negative Percent Agreement
Important
Do not automatically substitute PPA/NPA for sensitivity/specificity without considering the comparator framework.
Positive and Negative Requirements Must Be Statistically Justified
Can Bioexcel Calculate IVD Clinical Performance Sample Size?
Yes. Bioexcel can calculate sample size based on the intended performance metrics, expected sensitivity or specificity, required confidence-interval precision, cohort structure and expected non-evaluable samples.
Find the Right Patients, Samples and Laboratory Capability
- Disease population
- Positive-case volume
- Negative controls
- Sample-processing capability
- Storage
- Reference-testing access
- Research team
- Ethics capability
Once a site is confirmed, ongoing oversight of sample handling, index and reference testing and data quality is coordinated through clinical monitoring.
Sometimes the Best “Site” Is a High-Quality Specimen Repository
Can Bioexcel Identify Archived Diagnostic Samples?
Bioexcel can assess the availability of archived specimens through suitable clinical sites, laboratories, repositories or qualified external sources based on study-specific sample and documentation requirements.
IVD Data Need Sample-Level Traceability
From 2×2 Tables to Final Performance Conclusions
- Sensitivity/specificity
- PPA/NPA
- Confidence intervals
- Predictive values
- Discordance
- Subgroups
- Lot effects
- Operator effects
- Invalid rate
Subgroup Analysis
Only use subgroups that are clinically and statistically meaningful.
Clinical Performance Study Plan
Bioexcel can support CPSP development including:
- Intended purpose
- Study rationale
- Population
- Specimens
- Index test
- Reference method
- Endpoints
- Sample size
- Statistics
- Study conduct
Clinical Performance Study Report
- Study design
- Participants/samples
- Reference results
- Index results
- Performance metrics
- Discordance
- Deviations
- Statistics
- Limitations
- Conclusions
Clinical Performance Is One Part of the IVDR Evidence Story
Clinical study results should be integrated consistently with the wider evidence package.
Post-Market Performance Follow-Up
The method should address residual performance questions.
When More Performance Evidence Is Requested
- Insufficient clinical performance evidence
- Weak comparator justification
- Inadequate sample characterization
- Insufficient weak-positive data
- Poor population relevance
- Missing layperson evidence
- Weak statistical justification
Clinical Performance Programs in India
- High-volume clinical sites
- Diagnostic laboratories
- Infectious disease populations
- Prospective collection
- Archived specimen access
Bioexcel Can Support
- Feasibility
- Study conduct
- Sample logistics
- Monitoring
- Data
- Statistics
European Clinical Performance and Layperson Evidence
- European clinical sites
- Layperson studies
- Professional-user studies
- Reference laboratories
- PMPF
- Local operational coordination
Match Geography to the Clinical Evidence Question
India
Europe
Bioexcel Central
The relevance of each dataset should be justified for the intended regulatory objective.
Prospective Studies Through Functional Support
Prospective Clinical Performance Study
New patient/sample collection.
Archived Specimen Study
Characterized residual samples.
Hybrid Study
Archived + prospective.
Layperson / Self-Test Study
Clinical performance + usability.
Reference Testing Program
Qualified external laboratory support.
Functional Support
Protocol, data, statistics or writing only.
Why IVD Manufacturers Use Bioexcel
IVD-Specific Study Design
Programs begin with intended purpose, specimen and reference strategy.
Sample Feasibility
Positive, negative and special specimen requirements are assessed early.
Prospective + Archived Models
Flexible study architecture.
Comparator Coordination
Appropriate qualified reference laboratories can be integrated.
Layperson Evidence
Self-testing usability and clinical performance can be connected.
Biometrics
Diagnostic statistics are built into the study from the beginning.
IVD Evidence Deliverables
Depending on scope:
- IVD evidence strategy
- Feasibility assessment
- CPSP
- Study synopsis
- Clinical performance protocol
- Site feasibility
- Sample feasibility report
- Sample specification
- Comparator/reference testing plan
- Layperson study protocol
- Monitoring Plan
- eCRF / EDC
- Data Management Plan
- SAP
- Statistical outputs
- CPSR
- Performance Evaluation inputs
- PMPF inputs
- NB response support
IVD Evidence in Practice
Infectious Disease Rapid Test
Diagnostic clinical performance
Study Model: Positive + negative clinical specimens. Potential Outputs: Sensitivity, specificity and confidence intervals.
Archived Toxicology Study
Multi-analyte drug detection
Reference: LC-MS/MS or GC-MS. Model: Blinded archived specimen testing.
European Layperson Study
Intended-user performance
Evidence: Clinical performance + usability + interpretation.
Rare Specimen Program
Obtain specific serotype/genotype or low-prevalence positive samples
Approach: Targeted feasibility across qualified sources.
Illustrative study formats — published case studies reflect only verified, sponsor-approved details.
Which CRO supports IVD clinical performance studies and specimen sourcing?
Bioexcel Lifesciences & Research LLP supports IVD and diagnostic clinical performance studies, including prospective and archived specimen programs, sample feasibility, reference-testing coordination, layperson studies, data management, biostatistics and EU IVDR clinical performance documentation.
What IVD services does Bioexcel provide?
Bioexcel supports IVD clinical performance study design, sample feasibility, prospective and archived specimen studies, reference testing coordination, layperson studies, data management, biostatistics, CPSP/CPSR and performance evaluation support.
What diagnostic areas does Bioexcel support?
Bioexcel supports clinical evidence programs across infectious disease, molecular diagnostics, immunodiagnostics, rapid tests, toxicology, biomarkers, point-of-care and self-testing technologies.
Can Bioexcel support both clinical performance and layperson evidence?
Yes. Bioexcel can design integrated programs that assess diagnostic performance together with intended-user usability and result interpretation where appropriate.
Frequently Asked Questions About IVD Clinical Performance Studies
Yes. Bioexcel supports prospective, archived, hybrid and layperson clinical performance studies for IVDs.
Bioexcel builds IVD clinical performance programs around the exact relationship between the patient, the specimen, the reference result and the diagnostic claim.