Discussion: Scaling up Diagnostic Testing Lawrence Barat, MD, MPH Senior Malaria Advisor USAID/PMI

Points of Agreement Goal: Malaria treatment should be based on the results of diagnostic testing for which quality is assured. In Africa, we are far from this goal. Diagnostic testing should not be a barrier to treatment for those who have malaria It is better to treat a few people who don’t have malaria, than it is to miss someone who does have malaria (i.e. sensitivity more important than specificity).

Observations Clinical diagnosis of malaria, when done correctly, will:  Result in the treatment of almost all persons with malaria  Likely contribute to excess morbidity and mortality resulting from other undetected illnesses Diagnostic testing, when done correctly, will:  Miss a small percentage of cases of malaria  Probably not result in a large cost savings  Reap benefits, in the short to medium term largely from improved management of non-malarial illness

Only 1 in 4 patients with fever underwent diagnostic testingOnly 1 in 4 patients with fever underwent diagnostic testing Approx. 1/3 of patients with negative blood slides were treated for malariaApprox. 1/3 of patients with negative blood slides were treated for malaria

Quality Diagnosis Requires A good test Reliable stocks of supplies and equipment Appropriate facilities and bio-safety measures Test is done correctly Right people are tested Treatment is based on results Patient accepts and follows prescribed treatment

Challenges A good test  Real-life durability of RDTs unclear  Quality of microscopy substandard Reliable stocks of supplies and equipment  Supply chains are weak or non-existent  Maintenance is challenging Appropriate facilities and bio-safety measures  “Cool chains” don’t exist  Biohazardous waste disposal needed

Challenges Test is done correctly  Supervision & QA/QC systems weak or nonexistent  Much of the testing will not be done in labs Right people are tested  OPD attendance can be very high Treatment is based on results  Providers may not follow results  Alternative drugs (antibiotics) often not available Patient accepts prescribed treatment  Patients may seek out other sources of treatment

Gaps in Knowledge Durability/stability of tests in peripheral settings Use by clinicians  Who gets tested?  Does test result affect treatment decisions? Expectations of patients/caregivers and their acceptance of test results Best practices for training and supervision Feasibility of QA/QC at facility/community level Integration  Mgmt of other childhood illnesses at community level  Laboratory strengthening for TB, HIV, etc.

PMI Support for Diagnostic Testing Support for policy development, training, supervision, QA/QC, refurbishment of reference labs for microscopy and RDTs IMaD Project- currently supporting lab strengthening activities in 10 countries Procure RDTs, microscopes, and lab supplies and strengthen supply chain management Operations research