Rapid Diagnostics CHAI Experience. 6 th Moving Forward in Diagnostics Forum Les Pensieres November 7, 2012

Transcription

1 Rapid Diagnostics CHAI Experience 6 th Moving Forward in Diagnostics Forum Les Pensieres November 7, 2012

2 CHAI is working in 12 countries on HIV POC test implementation Kenya Tanzania Ethiopia Malawi Mozambique Zimbabwe Uganda Zambia South Africa Lesotho Swaziland India 2

3 POC capabilities are advancing over time 3 rd Generation 1 st Generation Samples: Urine, oral fluid, capillary blood Detection targets: Antibodies, antigens, simple biochemical reactions Examples: Rapid test strips, dipsticks, simple instruments 2 nd Generation Samples: Same Detection targets: Whole cells, DNA or RNA Improved methods: Sample processing, result readout in instruments Examples: CD4- cell count, HIV viral load, tuberculosis diagnosis and potential drug resistance Samples: Same + breath, and other samples Detection targets: Nucleic acid sequencing (proteomics) Improved methods: Multiple test formats, fully automated testing and analysis/display of results, wireless transmission of result data Examples: Antiviral and antibiotic drugresistance screening, home-based testing 3

4 Evaluation: Time From Diagnosis To CD4 Staging And ART Initiation There is a clear impact of point-of-care diagnostic technologies shows similar results in Uganda Accurate Malaria Testing TB Case Detection & Treatment Initiation Malaria rapid tests increased testing rates of suspected cases from 5% in 2000 to 45% in Rapid NAT-based testing for TB increased the rate of case detection by up to 50% and reduced the time to treatment initiation by a factor of 10 2,3 HIV Treatment Staging 4 POC testing for CD4 at primary health clinics: 2x the rate of initiation of ART 1/2 the time to treatment initiation. Source: 1 WHO 2012; 2 Boehme et al (2011), 3 Vassall (2011); 4 Jani et al (2011) 4

5 Multiple loss points between diagnosis and ART Average Pre-ART Loss Rates Between Various Stages From Testing To Initiation ( ) Testing to staging Staging to enrollment Retention in pre-art care 45% 54% 54% Largest comprehensive study found that only 33% of people who test HIV+ are ultimately enrolled in treatment Eligible to initiation 34% Source: Rosen and Fox (2011); Toward Universal Access, WHO (2010) 5

6 Estimates of wastage with conventional diagnostics are significant Based on weighted average of data from 3 countries 1, 46% of CD4 test results were NOT received by the patient 2 (n=12 million tests in 2010) Based on an average of 3 countries from a 2009 UNICEF review of EID service delivery, 50% of positive EID test results are NOT received by the patient 3 54% 46% Results not received Results received 50% 50% Results not received Results received Wastage associated with CD4 and EID tops $60+ million per year and almost 6 million tests where patients do not receive the result 3 Sources: 1 Mozambique: LTFU estimated based on Jani et al (2011); Malawi; MOH Malawi; South Africa: Larson et al (2011); 2 Global volumes based on CHAI data; 2 CHAI data; Assuming ~1,400 tests demanded per year at average health center across 9 African countries; CD4: 5.5 million results not received/$58 million wasted; EID: half estimated 300k tests results not received/$7.5m wasted; 3 A Multi-Country Review of HIV Early Infant Diagnosis Service Delivery 2009

7 POC CD4 testing as an intervention to reduce LTFU Reduction in the median time to complete CD4 staging: from 33 days to 3 days Ilesh V Jani, Nádia E Sitoe et al: Effect of point-of-care CD4 cell count tests on retention of patients and rates of antiretroviral therapy initiation in primary health clinics: an observational cohort study. Lancet 2011; 378:

8 POC saves significant costs through more efficient service delivery Results Received in Mozambique Using Conventional vs. POC CD4 40% 60% 100% Results not received Results received Conventional CD4 POC CD4 $10.56 $11.81 All-in-price per test* $17.66 $11.81 Price per result received Mozambique could purchase an additional 232,000 POC tests with the amount of wastage resulting from conventional tests All-in-price per test* based on estimates across 9 countries at average CD4 volumes per clinic of 1,400 8

9 However, impact of POC CD4 is not uniform Clinic 1 4% 3% 93% Limiting Factors: - Human resources - Patient overflow - Clinic workflow Same day CD4 result 24% Clinic 2 No same-day CD4 result 76% Transferred with outdated CD4 result - Change of culture - Patient education

10 The impact of POC CD4 may depend on different deployment models, e.g. hours of operation or number of clinic days Some sites may have low impact of POC CD4 due to patients coming only at certain hours in the morning or devices only being used on certain clinic days 10

11 Evaluation: Time From Diagnosis To CD4 Staging And ART Initiation Targeted activities are necessary to address barriers to adoption shows similar results in Uganda Barriers Activities Price at market entry Price higher than conventional CD4 All-in costs poorly understood Unclear regulatory pathways No standard local regulatory pathway Evaluations required in each country Lack of normative guidance Lack of evidence on impact and appropriate use Increase normative guidance National policies/planning Product and site selection Monopoly mitigation/competition Better understand pricing Understand value of POC testing Understand full cost of lab based testing Speed regulatory approvals Speed initial evaluations Harmonize Conduct pilots and operational research Define optimal deployment models Support policies/planning Select ideal products for each setting Develop guidance on how to integrate POC Implementation challenges Training, quality assurance, connectivity Radical clinic workflow changes required Establish ongoing operations for POC Product agnostic implementation 11

12 Updated testing policies and plans Malawi Task force formed by MOH in February 2012 to draft strategy Strategy was for CD4, EID, VL, chemistry, hematology, opportunistic infections such as TB, etc. Strategy defines POC, provides guidelines and criteria for selecting products and sites for deployment, and encourages competition in the marketplace Includes a roadmap for product-agnostic systems for training, quality assurance, supply chain and distribution, service and maintenance, data management, and M&E GOVERNMENT OF MALAWI MINISTRY OF HEALTH Point-of-Care Implementation Guidelines Directing Scale-up of Point-of-Care Testing for HIV-related Diagnostics in Malawi June 2012 Strategy approved in June

13 Product selection criteria Inclusion criteria include: No constant power source needed (i.e. battery-powered) Minimal sample and reagent preparation requirements Easy to use (number and complexity of steps) Internal QC No refrigeration required After sale support available Performance criteria include: Type of technology (e.g. disposable, handheld, etc.) Result display and storage Connectivity Batching Shelf life Type of sample required Throughput Cost 13

14 Understanding testing distribution will help design of products. Distribution of potential testing volumes and testing sites by market segment (sites without conventional CD4 on-site) % of Potential Testing Volume % of ART Testing Sites 60% 50% 40% 50% 50% of potential testing volumes are at 8% of sites 35% 34% 30% 20% 10% 8% 21% 10% 14% 13% 14% 0% >20 Tests per Day Tests per Day 5-10 Tests per Day 1-5 Tests per Day 2% <1 Test per Day 14

15 and help countries select products appropriate for their settings A B C D E F TOTAL Distribution of Testing Need >20 Tests per Day 30% 54% 0% 73% 53% 11% 50% Tests per Day 30% 20% 8% 17% 20% 26% 21% 5-10 Tests per Day 21% 13% 15% 7% 15% 20% 14% 1-5 Tests per Day 17% 12% 54% 3% 12% 36% 14% <1 Test per Day 1% 1% 24% 0% 1% 7% 2% Distribution of Testing Sites >20 Tests per Day 7% 9% 0% 35% 9% 1% 8% Tests per Day 13% 11% 2% 24% 12% 5% 10% 5-10 Tests per Day 19% 14% 4% 21% 18% 7% 13% 1-5 Tests per Day 44% 36% 32% 18% 39% 37% 35% <1 Test per Day 16% 30% 62% 2% 22% 50% 34% Distribution of testing volumes varies significantly by country 15

16 Integration of lab-based, POC, and near-poc testing Some facilities in the middle can be served by any method of testing The ideal balance needs to be determined Lab-Based Testing Point of Care Near-POC 16

17 Implementation: Develop product agnostic systems Product Selection Procurement/ Tendering Training QA/QC Objective selection criteria Exclusion criteria to determine eligibility Volume discounts and leasing Service and maintenance Standardized sample collection Systems training on clinic workflow Participation in global EQA schemes Daily internal controls Patient Flow Data management Data Analysis Mentoring/s upervision Timing of ART and OI treatment Patient movement through services Data systems to manage devices Data transmitted remotely by modem Tracking volumes for forecasting Program mgmt with real time data For effective POC testing, new product agnostic systems are needed Regular site level follow up Problem solving w/ real-time data 17

18 Laboratory systems strengthening Train healthcare workers on new technologies to ensure appropriate use of POC systems Establish quality assurance system to identify quality problems and ensure the accuracy of testing Develop a service & maintenance plan to minimize device down time Implement a data management system, including through connectivity to improve inventory management, service & maintenance, and QA Build reliable supply chains 18

19 POC CD4 Levey-Jennings plot - connectivity

20 POC CD4 Connectivity reduces error rates

21 Questions