1. Ilesh V. Jani Instituto Nacional de Saúde Mozambique
Field Evaluations of Point-Of-Care Virologic Technologies for Early Infant Diagnosis
Ilesh V. Jani
Instituto Nacional de Saúde
Mozambique

2. What are we trying to find out with a field evaluation?
Is the performance of the new test (or testing algorithm) worse/as good as/better than the current diagnostic option?
Is the new test (or testing algorithm) worse/as good as/better for patients?
Is the new test (or testing algorithm) worse/as good as/better for health systems?

3. Some factors that influence the quality and the impact of diagnostic test evaluations
Study design
Measured outcomes
Risk of bias
Study settings
Precision of evidence
Data analysis and publication
Adapted from: Schünemann et al (2008); BMJ

4. 1 & 2. Study design and measured outcomes
Randomised controlled trials are the best way to evaluate new tests
“Accuracy/Precision” studies are more prone to bias but have been the only “viable” option for EID tests
Test evaluations should measure patient-important outcomes
Evaluations should measure (or infer) system-important outcomes
From: Schünemann et al (2008); BMJ

5. 3. Risk of bias Consecutive patients under routine conditions
No “enrichment” by disease or biomarker status
Well defined inclusion/exclusion criteria
Blinding of test results

6. 4. Study settings
Study sites – differences between type of health facilities where study takes place and those where test will be deployed
Study population – differences between infants studied and those for whom test is intended
Test operators – differences between type of operators in the study and those who will use it in the health system

7. 4. Study settings – how to select study sites?
Annual EID Volume per Site – Mozambique 2012
60 sites account for 50% of annual volume
Weekly EID Volume per Site – Mozambique 2012
More than 10 samples per week (n=16)
Less than 2 samples per week (n=460)

8. 5. Precision of evidence
Wide confidence intervals impact the quality of evidence
Low number of HIV+ children in studies
Implications for length, size and budget of studies
Sensitivity and specificity of a POC NAT EID Assay
From: Jani et al (2014); JAIDS

9. 6. Data analysis and publication
Data analysis should consider:
Analytical performance
Analytical performance of the test at a single time point vs. within a testing algorithm
Operational performance
Potential increase in access to tests and treatment
Potential decrease in diagnostic delays and associated risks, including reduced anxiety and loss to follow up
Cost-efficiency issues
Budget impact
Publication bias

10. 6. Data analysis – balance test performance with access issues
A point-of-care assay with a lower sensitivity may still effectively reach more infants due to lower rates of loss to follow up
EID program indicators in Mozambique are reaching a plateau due to health system limitations

11. Final remarks
Deployment of novel EID assays should be informed by high quality evaluations under field conditions
Evaluations should measure patient-important and system-important outcomes
Decisions about the incorporation of new EID assays in health systems should take into consideration other factors then just test performance

12. Acknowledgements Ministério da Saúde, Moçambique
Instituto Nacional de Saúde, Moçambique
Clinton Health Access Initiative