Laboratory  Capacity  Evalua1ons  in  LMICs  John  Barber,  MS2  

University  of  Massachuse?s  Medical  School,  Founda1on  for  Innova1ve  New  Diagnos1cs    

             

           Evalua'ng  Laboratories  as  Poten'al  Project  Partners:    Overview  •  FIND  is  seeking  strong  laboratory  partners  around  the  world  to  collaborate  with  on  several  specific  

studies  and  projects  in  the  near-­‐term:  •  FIND   has   established   a   new   program   focused   on   febrile   illnesses,   aiming   to   address  

deficiencies  in  diagnos1cs  to  improve  the  health  of  both  individuals  and  communi1es.  •  FIND  aims  to  build  a  consor1um  of  select  partners  to  prepare  for  the  next  outbreak.  

1.  Improving  Febrile  Pa5ent  Management  1.1  Mul1plex  PCR  Evalua1on  for  Pathogen  Iden1fica1on  •  Background:  Mul1plex   assays,   commonly   used   to   provide   rapid   iden1fica1on   of   infec1ous   agents   in  

high  income  coun1es,  are  rarely  available  below  Regional  Hospitals  in  LMICs.  •  Goal:   Iden1fy   valuable   diagnos1c   tools   ready   to   be   implemented   and/or   gather   feedback   for  

manufacturers  on  limita1ons  and  necessary  improvements  for  implementa1on  in  LMICs.  Ø  Impact:  Effec1ve  mul1plex   assays  may   provide   valuable   informa1on   for   pa1ent  management,   public  

health  interven1ons,  pathogen  outbreak  detec1on,  and  epidemiological  data.  

1.2  Bacterial  Biomarker  Rapid  Diagnos1c  Test  Evalua1on  •  Background:  With  no  way   to  determine   the  class  of  pathogen   in  many  health  centers,  an1bio1cs  are  

very  oVen  prescribed  for  pa1ents  without  bacterial  infec1ons.  •  Goal:  Iden1fy  accurate,  rapid  lateral  flow  immunoassays  &  low-­‐cost  ELISAs  to  iden1fy  sepsis.  Ø  Impact:  Improve  accuracy  of  treatment  and  reduce  incorrect  use  of  an1bio1cs  at  every  level  of  care.    1.3  Biobanking  Febrile  Pa1ent  Samples  •  Background:  Researchers   and  diagnos1c  manufacturers   currently   lack   access   to   samples   from   febrile  

pa1ents  necessary  to  aid  their  R&D  efforts.    •  Goal:  Establish  a  biobank  of  well-­‐characterized  samples  from  febrile  pa1ents  from  around  the  world.  Ø  Impact:  Advance  the  development  of  new,  innova1ve  diagnos1cs  focused  on  management  of  pa1ents  

with  febrile  illnesses.  

2.  Outbreak  Preparedness  2.1  Establish  Diagnos1c  Preparedness  Consor1um    •  Background:  To  prevent  epidemics,  capacity  must  be  improved  to  iden1fy  outbreaks  early  and  respond  

with  rapid  and  coordinated  deployment  of  diagnos1cs,  treatments,  and  containment  strategies.    •  Goal:   Support   surveillance   ac1vi1es   and   build   response   capacity   by   using   exis1ng   technologies   and  

facilita1ng  new  R&D  to  ensure  rapid  scale  up  in  the  event  of  an  outbreak.  Ø  Impact:  Increase  na1onal  and  interna1onal  capaci1es  to  respond  to  outbreaks  around  the  world.  

Project  Objec'ves  •  General:  Establish   rela1onships  with  capable   laboratories   to  build  FIND’s  network  of  partners  around  

the  world  that  may  be  engaged  for  future  collabora1ons.  •  Specific:  Evaluate  laboratories  in  Gabon,  Tanzania  and  Laos  to  assess:  

•  Capacity  for  specific  upcoming  studies  &  projects  focused  on  febrile  illnesses  •  Current  capacity  and  deficiencies  to  effec1vely  respond  to  the  next  outbreak  

         (see  middle  panel)    

Founda'on  for  Innova've  New  Diagnos'cs  (FIND)  •  FIND   is   an   interna1onal   non-­‐profit   organiza1on,   headquartered   in   Geneva   with   several   ongoing  

collabora1ons  with  the  WHO  and  other  ins1tu1ons  around  the  world.  •  FIND  works  to   improve  pa1ent  care  and  public  health   in   low  and  middle-­‐income  countries  (LMICs)  by  

advancing   access   to   exis1ng   technologies   and   by   promo1ng   the   research,   development   and  implementa1on  of  new,  innova1ve  diagnos1cs.  

Project  Background:    1.  Febrile  Illnesses  

•  Febrile   illnesses  are  a  major  cause  of  hospital  admissions  and  deaths   in  LMICs,  especially   for  children  under  five  years.  

•  Current  prac1ce  frequently  results  in  the  mistreatment  of  pa1ents  with  febrile  illnesses:  •  A  study  in  northern  Tanzania  found  malaria  was  the  diagnosis  for  60.7%  of  febrile  pa1ents,  but  

the  true  cause  of  fever  in  only  1.6%  of  pa1ents.1  •  A  2013  WHO   review  on   Fever  Management   in   Peripheral  Health   Care   Sefngs   reported   “in  

places  where  clinicians  have  been  convinced  not   to  prescribe  an1-­‐malarials   in  RDT  nega1ve  pa1ents,  limited  guidance  has  resulted  in  over-­‐prescrip1on  of  an1bio1cs.”2  

•  The  effects  of  pa1ent  mistreatment  include:  •  Poor  pa1ent  outcomes  and  increased  mortality  due  to  incorrect  treatment.  •  Individuals  may  experience  side  effects  from  ineffec1ve  medica1ons.  •  Community  may  develop  an1-­‐malarial  &  an1bio1c  resistant  pathogens.  

Ø  Goal:  Improve  access  to  and  availability  of  accurate  diagnos1cs  to  advance  care  of  pa1ents  with  febrile  illnesses  and  slow  the  development  of  an1-­‐malarial  &  an1bio1c  resistance.  

2.  Outbreak  Preparedness  •  The   2014   Ebola   Outbreak   highlighted   major   deficiencies   in   the   local   capacity   of   some   healthcare  

systems   to   address   outbreaks,   as   well   as   the   inability   of   the   interna1onal   community   to   effec1vely  respond  in  a  1mely  manner.  

•  Prepara1ons  must  be  made  to  ensure  such  an  epidemic  never  occurs  again.  Ø  Goal:  Improve  local  and  interna1onal  capacity  to  iden1fy  and  respond  to  the  next  outbreak.    

Laboratory  Evalua'on  Conclusions    Summary  •  Iden1fied  well-­‐qualified  laboratories  in  Gabon,  Tanzania  and  Laos,  each  with  specific  areas  of  strength.  •  All  laboratories  have  extensive  experience  conduc1ng  epidemiological  research.  •  FIND’s  projects  and  goals  are  in-­‐line  with  the  current  focus  and  interests  of  these  laboratories.  •  All  are  eager  to  partner  with  FIND,  cri1cally  important  for  any  collabora1on.    

Center  for  Research  in  Lambarene  (CERMEL)  Lambarene,  Gabon  

•  Extensive  capacity  throughout,  very  li?le  oversight  would  be  necessary  for  collabora1ons.  •  Strong  rela1onships  with  government,  public  healthcare  system,  and  local  popula1on.  •  Currently   shipping   samples   abroad   and   able   to   fully   characterize   specimens:   strong   partner   for  

biobanking  work.  •  Four  partnering  health  centers  expand  catchment  popula1on  to  ~70,000.  •  Catchment  popula1on  from  one  locality  limits  pa1ent  diversity  and  malaria  is  common  cause  of  fever.  •  Excellent  partners  for  any  study  in  which  their  catchment  popula1on  is  appropriate.    

Mbeya  Medical  Research  Center  (MMRC)  Mbeya,  Tanzania  

•  Good  capacity  in  several  research  areas.  Some  oversight  should  be  provided  at  project  launch.  •  Very  strong  rela1onship  with  government  and  public  healthcare  system.  •  Currently   shipping  samples  abroad,  however  capacity   to   fully   characterize   specimens  on  site  must  be  

improved:  with  addi1onal  investment  a  strong  partner  for  biobanking  work.  •  Able   to  partner  with  any  clinic  or  hospital   in   the   region  permifng  extensive  popula1on  selec1on   for  

studies.  MMRC  ensures  quality  at  external  facili1es  by  placing  MMRC  team  on  site  for  study  work.  •  Recently  led  na1onal  symposium  on  outbreak  preparedness.  

 Lao-­‐Oxford-­‐Mahosot  Hospital  -­‐  Welcome  Trust  Research  Unit  (LOMWRU)  

Vien'ane,  Laos  •  Good  capacity  in  several  research  areas  with  BSL  3  laboratory  on-­‐site.  •  Posi1ve  rela1onship  with  government,  however  communist  bureaucracy  presents  impediments.  •  Previous   request   to  ship  samples  abroad  was  denied,  however  new  Health  Minister   is   former  Deputy  

Director  of  Mahosot  Hospital,  with  whom  LOMWRU  has  strong  rela1onship.  •  Able  to  partner  with  any  provincial  hospital  around  the  country  enabling  extensive  popula1on  selec1on  

for  studies.  •  Government  would  not  likely  reach  out  to  LOMWRU  for  support  in  outbreak  response.  •  Collabora1ons  will  require  hiring  new  LOMWRU  technicians  or  reques1ng  staff  from  provincial  hospital,  

extensive  training  will  be  necessary.                                  Acknowledgements  &  Thanks:  •  Many   thanks   to   Sabine  Di?rich   and   FIND   for   leading   this   project  with   tremendous   energy   and   great  

vision.  •  CERMEL,   MMRC   and   LOMWRU   for   the   1me   they   provided   and   their   commitment   to   improving  

diagnos1cs  and  pa1ent  care.  •  Dr.  Chin,  Dr.  Gibson  and  UMMS  for  facilita1ng  this  experience.  University  of  Massachuse?s  Medical  School  2016  Global  Health  Poster  Session  

CERMEL:  Lambarene    (central  lab  /  HQ)  &  Fougamou  (rural  health  post),  Gabon  

MMRC:  Mbeya  (central  lab  /  HQ)  &  Matema  Hospital,  Tanzania  

LOMWRU:  Vien5ane  (central  lab  /  HQ)  &  Provincial  Hospital,  Laos  

1   Crump,   John   A.,   et   al.   (2013)   "E1ology   of   Severe   Non-­‐malaria   Febrile   Illness   in   Northern   Tanzania:   A   Prospec1ve   Cohort  Study."  PLoS  Negl  Trop  Dis  PLoS  Neglected  Tropical  Diseases  7.7    2  WHO  (2013).  WHO  Informal  Consulta1on  on  fever  management  in  peripheral  health  care  sefngs:  a  global  review  of  evidence  and  prac1ce.  h?p://www.who.int/malaria/mpac/who_consulta1on_fever_management_briefing.pdf