1 Erwan Piriou, PhD Laboratory advisor, Médecins Sans FrontièresAre we ready for the next outbreak? Applying lessons learned from Ebola and other outbreaks for diagnostic preparedness Erwan Piriou, PhD Laboratory advisor, Médecins Sans Frontières

2 Ebola – diagnostic developments!

3 (near)POC Ebola and supportive tests in GuineaReduction of Ebola PCR TAT from 334 min in routine laboratory to 163 min with Xpert Ebola1 “Chaillet” container set-up at interface of highlow-risk zones with POC biochemistry2 1Van den Bergh et al. Emerg Infect Dis https://dx.doi.org/ /eid 2 De la Vega et al. Expert Review of Anti-infective Therapy

4 Some challenges remaining…Implementation strategy / place in system (acceptance?), particular challenges due to biosafety of user and patient Supply strategy, in and outside outbreak situation, (pre)positioning? Intended use… what do we really mean? E.g. Ebola LFA with imperfect sensitivity and/or specificity

5 So can a new Ebola RDT even be used…?Clear understanding of the intended use of the tests including whether there is a need to undertake confirmatory testing Antigen detection assays in general are less sensitive or specific compared to NAT, although both can be used to establish the laboratory diagnosis of EVD With decreasing prevalence, PPV of RDT becomes too low At end of outbreak, integration with differential diagnosis becomes more important Need for “full” (P4) PPE also for differential (incl malaria) testing ?

6 And…if it’s not only EbolaA lot of laboratory capacity for Ebola testing during outbreak, and maintained after However: capacity for more regular outbreaks, including measles, cholera, …? E.g. Sierra Leone Public Health laboratory, despite support by many organizations Contrast between capacity “on paper” (lab set-up, staff trained) and reality (no power, no supplies) Lack of information regarding reference laboratories (what is their real / operational capacity): role WHO, ASLM? Complicated sample referral (authorizations, transport)

8 Measles – DRC • <<50 % of suspected measles cases confirmed by laboratory • Laboratory results points to an outbreak (or several outbreaks) of rubella. • High % of cases is neither measles nor rubella, remains unknown • Clinical diagnosis of measles difficult and prone to error. Symptoms for Rubella are little specific and fit in the measles case definition  large over-diagnosis of measles in clinical settings. • Laboratory testing is NOT supporting clinical case management, only epidemiological surveillance (1 laboratory in country, no decentralization)

9 Yellow Fever, Angola (MSF-OCBa) – challenges with YF and differential diagnosisLaboratory confirmation of YF taking up to 6 weeks (need for neutralization due to cross-reactivity in IgM ELISA / negative PCR at admission) High rate of co-infection w malaria Co-infections w acute Dengue (RDT, cross-reactivity?), leptospirosis (new RDT) Most admissions w/o clear ethiology for icteric fever sindrome

10 Can we use existing tools better? E.g. Hepatitis EPoor capacity for laboratory confirmation Some POC tools exist that may be useful, but data is limited, incomplete regulatory status E.g. S Sudan 2014: RDT (Assure HEV IgM1) at POC, IgM ELISA (Wantai2) ELISA POS ELISA NEG RDT POS 35 1 RDT NEG 4 56 Sensitivity 89.74% ( ) Specificity 98.25% ( )

11 To conclude…nothing new and lots to do?Need for better mapping of capacity and access to that information - ASLM, WHO  countries? Capacity building and sustainability beyond implementation (supply chain, eq’t maintenance, …) Real decentralization (at international level as well as national) of diagnostic capacity, incl place of POC – needs not only for epidemiology but also patient care Opportunities to use existing tools if better understanding their performance and deployability Need new tools, ASSURED Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free, Deliverable to end-users

12 Thanks!