unit 5 surveillance from control to elimination tools and procedures to get information about...
TRANSCRIPT
Unit 5Surveillance
from Control to Elimination tools and procedures to get information
about malaria
Training course on EliminationChiangmai, Thailand10-21 August 2015
Unit 5 - Objectives1. Surveillance activities in different phases 2. Role of diagnosis in elimination, esp microscopy3. Interpreting laboratory reports4. Quality Assurance for Microscopy (and RDTs)5. Use of geographical information system 6. Case detection7. Investigation of case and foci8. Classification of cases and foci 9. Data recording and reporting10. Epidemiological Indicators used in surveillance11. Establish a surveillance system
“Surveillance” in different phases of malaria control to elimination involves transitions/changes.
• “Malaria surveillance” has different meanings in different situations (pages 1-5, WHO Surveillance Manual, Box 1.1/1.2/1.3)– High transmission (e.g. >10% prevalence)– Low transmission (<10% prevalence)– Very low transmission – No transmission
• In GMS countries, some areas are in Control Phase and other areas in Pre-elimination/Elimination Phase.
Table 1 Differences btw Control and Elimination (p.2)Phase: Control Phase Elimination phase
Transmission: High/Moderate Low Very low
Incidence: Cases/deaths commonLittle variation (time/geography)
Cases/deaths less common, according to mosquito exposureVariable(time/geography)Marginal populations
Cases irregularImported cases may be high %Focal distribution
Fevers:Health Facility attendance:
High % due to malaria
High % due to malaria
Small % due to malaria
Low % due to malaria
Very small % due to malaria
Aim of program Reduce deaths & cases Case reduction Stop transmission
Resources: Data recording:
Low quality/poor access to servicesAggregate numbers(prevalence/surveys)
Wide availability of diagnosis/treatmentList of inpatients & deaths->list all cases
Resources to investigate every case
Case details
Investigation: Inpatient cases?? Inpatient case->outbreaks Every individual case
Moving from phase to phase to zero
• In simple terms, the difference between: 10,000 vs 1000 vs 100 vs 10 vs 0
• 10,000 cases per year– impossible to look at every case
• 100 cases per year– Very possible to look at every case
• The transition from control to elimination depends on resourcing and staffing vs number of cases.
1-Surveillance for Elimination•Surveillance becomes a core intervention•Staff have to go out of the office•Field investigations of cases and clusters (foci) •Case by case and focus by focus•Simple framework of systematic activities•Full documentation for eventual certification
1-Surveillance for Elimination•Not complicated, but a new method•Set of strategies is available, but to be adapted to:– Receptivity– vulnerability of country– strata– focus
1-Surveillance for EliminationWHEN and WHERE DO WE START?•OPERATIONAL STRATIFICATION•STEP BY STEP ELIMINATION (at sub-national)
1-Surveillance for EliminationStratification: ADMINSTRATIVE UNITS FOCUSAPI (10/1000) ONE CASE
1-Surveillance for Elimination•Find every case and finally the last parasite•When we find parasite, we prevent all transmission by mosquito.•Clean the foci and keep them all malaria-free for 3 years•Not only sick people, but also reservoir•Prevent re-infection from outside
Exercise 5.1
• Using Box 1.1 to 1.3 (WHO Elimination Surveillance manual), make a table of the differences in each phase.
• Each box starts with how case registration is handled, so start there.
ExampleFeature Control (high) Control (low) Elimination
Register of individual cases
Cases, sometimes without parasitological confirmation, at health facility only (maybe a log book)
Cases, all parasitologically confirmed at health facility level, with aggregate data at district level
Cases, with all case details for every case.
Etc…..
2.Laboratory diagnosis for malaria elimination
Malaria diagnosis
Microscopy RDTs Molecular
PCR
Immuno-diagnosis
??
??
Role of microscopy
Advantages
• Good sensitivity (if microscopist well trained)
• Can quantify & differentiate parasite species and stages, including gametocytes
• Provides results quickly (if staff in place!) to guide treatment decisions
• Preserved slides serve as good documentation material for later certification
Disadvantages• Good training and regular
refresher training (every 2-3 years) is required
• Labor intensive• Requires strong QA and
supervision to maintain quality• Impractical or costly at peripheral
health facilities? • Microscopy skills are gradually
disappearing in many countries, partly due to declining slides to be examined
Quality assurance for malaria microscopy
Microscopy QA systems:• Critical for countries to maintain reliable diagnosis!• Needs well-organized institutional set-up with dedicated
staff and reference laboratories at national and subnational level (laboratory network)
• Involves a system for cross-checking of slides and on-site supervision by senior microscopist/Validator
• Training and regular re-fresher training of microscopists (every 2-3 years minimum) is essential
• External Competency Assessment (ECA) with rating of microscopists (Level 1-4), known also as Accreditation
• Establishing of malaria slide bank• Proficiency testing – distribution of prepared stained blood
slides in a blinded manner to laboratories in the Network
Support for microscopy QA implemented through WHO and ACTMalaria
External competency assessment in Viet Nam, June 2012, Photo from Ken Lilley
Regional malaria slide bank at the Research Institute for Tropical Medicine, Manila, Philippines
Role of RDTs
Advantages• Easy to use for everyone,
minimal training required• Provides quick results• Practical for large-scale field
deployment• Reasonably good sensitivity
for symptomatic cases, but low sensitivity for asymptomatic cases (or in non-immune patient)
Disadvantages• Cannot detect low density
infections• Cannot detect gametocytes• Cannot quantify parasitaemias• Pf/PAN tests cannot distinguish
Pf from mixed infection (but other RDTs are available)
• In elimination programs, probably need confirmation by microscopy (at least for a minimum sample of tests)
• Heat stability is problem?
Instruction and supervision in RDT use has changed malaria diagnosis at
peripheral health facilities
RDTs were introduced Vanuatu during 2009-2010, which increased diagnostic services for malaria at health facility level throughout the country from 10% to 90% .
Many RDTs in the market - independent guidance on selection and procurement of malaria RDTs
QA Batch testing of malaria RDTs
Role of PCR
Advantages• Very high sensitivity and
specificity!• Easy to collect finger-prick
blood samples, dried on filter paper and sent to lab – large scale epidemiological surveys
• Provides the possibility for other parasite gene studies, e.g. genotyping in drug efficacy studies
Disadvantages• Very demanding technique to
implement and sustain• Requires lots of training• Requires high-standard
technical service and maintenance
• Impractical outside major hospitals and laboratories
• Takes longer time to get results back – thus no role in routine case management
• Expensive
PCR lab setup requirements
An exception to previous statements (Cambodia)
Role of LAMP
Advantages• Very high sensitivity and
specificity!• Easy to collect finger-prick
blood, dried on filter paper and sent to lab – large scale epidemiological surveys
• Provides (relatively) quick results
• Inexpensive?
Disadvantages• Demanding to implement
and sustain• Requires good training• Requires some technical
service and maintenance• Impractical outside
laboratories??
Role of immuno-diagnosis/serology
Advantages• Very sensitive malaria
screening tool, e.g. screening of blood donations
• Can rule out infection in a returning traveler with persistent intermittent symptoms, but negative microscopy
• Can be used as part of epidemiological surveillance to identify areas of continued transmission in the pre-elimination phase
Disadvantages• Requires good laboratory
support and lots of training• Expensive• Plays a limited (if any) role
in the elimination phase
So, which method to use for elimination??1) Quality-assured microscopy continues to be number 1
method for routine case detection and verification2) If microscopy not possible to sustain, RDTs offer a
reasonable alternative; however, blood slides should be kept and sent for confirmation and QA in a minimum sample of cases and non-cases.
3) Microscopy and RDTs can also be used for active case detection, although cases will likely be missed
4) RDTs can be used for quick screening (eg, at airport)5) Molecular methods will find additional cases – likely to
increase effectiveness of active case finding – but is not feasible in many (most) settings
WHO recommendations on malaria diagnosis in low-transmission settings (Sept 2014)
• WHO recommendations (Sept 2014) clearly say that whatever is recommended today, there are likely to be changes as time goes on.
• They state that microscope or RDT is best compromise for elimination, but then they go on to describe situations where Nucleic Acid Amplification (eg PCR) can or should be used.
• In other words, despite the attempt to give clear guidelines, there is some slipping and sliding…
2-Laboratory diagnosis - ExercisesExercise 5.2a
Evaluate the strengths and weaknesses of RDT diagnosis for elimination – is the RDT suitable for use in elimination phase?
E.g., consider the RDT your program uses now, the different types of RDTs now available, sensitivity/specificity, and how this may change in future.
Exercise 5.2bEvaluate the strengths and weaknesses of microscopic
diagnosis for elimination – is the microscope suitable for use in elimination phase?
E.g., consider the deterioration of microscope skills vs the rising use of RDTs.
Interpretation of lab results
• These are all important:– Species– Stages of P.falciparum (esp gametocytes)– Parasite densities (parasites per ul or 1+/2+/3+)
• What If report only says “Positive”….• What If report has full details, but clinical staff
does not understand the meaning….
• P.falciparum gametocytes and asexual stages are present in first blood exam,
• Meaning the case has been detected late– Pf gametocytes appear about 10-12 days after asexual
stages• Meaning an investigation should ask:– Why was a blood exam not ordered earlier?– Was the diagnosis missed at earlier time?– Did the patient not understand the seriousness of his
disease?– Etc.
Interpretation of lab results (example)
• P.falciparum asexual stages are reported in number of 100,000 per ul, or 5+
• Meaning:– High risk of deterioration and death, emergency
care needed immediately
Interpretation of lab results (example)
Exercise 5.3
• What kind of information should be reported in a lab report (elimination phase)? What is the value or purpose of each kind of information?