Balancing investment in point of care diagnostics versus laboratory testing in low resource settings. June 28, 2011

Transcription

1 Balancing investment in point of care diagnostics versus laboratory testing in low resource settings Workshop on TB and HIV Diagnostics Workshop on TB and HIV Diagnostics June 28, 2011

2 Complexity Delivery of diagnostics of Diagnostics services Procurement is complex.. & Supply Chain Simple, Point of Care Simple, Lab-based Complex, Lab-based Example HIV, Pregnancy, Malaria Rapid Test Microscopy for parasites, STDs, malaria Automated Analyzers for Hematology, Chemistry & HIV Specific Tests Where All health services Smaller Hospitals, Urban Health Clinics Hospitals Volumes High Moderate Moderate, some Low Supplies Shelf Life St Test Kit; basic phlebotomy consumables Few reagents, controls, basic lab & specimen related consumables Reagents, basic & specialized lab consumables, quality controls, specimen collection consumables 1-2 years Months Weeks to months Storage Cool chain Generally no refrigeration Refrigerated Cost/Test <$2 - $10 $.50-$3 $5-$45 06/07/2011 2

3 Diagnostics..with multiple Supply points Chain: of service Multiple Points of Service Referral Hospital Regional Hospitals District Hospitals Health Clinics Village Health Posts Community Health Workers

4 ...and often with limited infrastructure and resources

5 Significant investment in lab-based technology Annual lcd4 Test Volumes Global ART 10 In Care (LMIC only) ART CD4 % sites sites Labs with CD4 Tanzania ~ Mozambique Zimbabwe Malawi Uganda Kenya ~ Nigeria Ethiopia Zambia Total

6 HIV DNA PCR Laboratories HIV DNA PCR scale-up across 30 countries (excluding South Africa)

7 But still unmet need CD4 testing gap Annual CD4 volume (millions) Unmet need Infant HIV diagnosis gap

8 Why the gap? Firstly: Testing gaps are not only dependent on diagnostic capacity Significant programmatic and other resource limitations that define health care delivery help determine However: Laboratories are difficult to deploy with limited infrastructure Equipment breakdowns can result in up to 40% downtime Skilled staff are difficult to find and retain Centralized testing need robust sample transport and results delivery systems not always available Supply chain and quality systems can be challenges Loss-to-follow-up is high after centralized testing

9 Supply Each chain test requires challenges multiple products from different suppliers Test Category Number of products required to run test* HIV rapid test 8 Gram stain 20 AFB smear 30 Automated clinical chemistry 15 CD4 count (BD FACSCount) 15 HIV DNA PCR 53 Multiple products in different pack sizes Different shelf lives for different products Different cold chain requirements Minimum national inventory of products * Source: Consultation on Technical and Operational Recommendations for Clinical Laboratory Harmonization and Standardization, January 22-24, Maputo, Mozambique.

10 Only 25% of infants born HIV+ are in treatment 1 year later. Results are not communicated to more than half of all infants tested Only 25% of infants born HIV+ are in treatment 1 year later. Results are not communicated to more than half of all infants tested t Retention of Infants Throughout the Care and Treatment Continuum 48 74% Infants lost Infants in system % Positive Births Positive PCR Mothers Receive Results Infants Initiate Treatment Infants still alive after 1 year 74% of positive infants from 16 studied sites could not be accounted for and confirmed to be on treatment after 1 year Greatest loss occurs between a positive test and the return of results where 51% of infants are lost Chance of survival if HIV positive infant is not in treatment after 2 years is ~50% *December 2008 Stocktaking Report, UNICEF. **Data from 16 sites across different African countries. Data from 6 sites are from program inception through 15 June 2009, while the other 11 sites data are from program inception through 15 January 2009

11 Point of Care (POC) technology pipeline HIV detection Examples: In HIV rapid tests From 2012 also aso POC CD4, early infant diagnosis, viral load CD4 test examples:

12 But new test adoption takes time Estimated implementation timeline of new diagnostic platforms 6 18 months 6 12 Months 6 12 Months 3 10 Years Registration & Evaluation Procurement planning To 1 st Supply First phase implementation On going scale up Initial implementation : 2 3 years Scale-up : >7 years?

13 POC tests face similar challenges to lab-based tests but at more sites: o Supply chain o Maintenance o Quality assurance o Human resources

14 Potential POC test demand is highly distributed me CD4 volu Annual CD4 Volume per Site Frequency

15 True costs of POC testing are not always understood $18.00 Illustrative $16.00 $14.00 $12.00 $10.00 $2.00 $0.50 $1.22 $1.00 $0.10 $1.13 $2.04 $0.72 $1.25 $1.77 Maintenance Wastage HR $8.00 Equipment $6.00 $4.00 $7.80 $8.90 $2.00 Other Consumables Reagents $0.00 POC Test A POC Test B

16 Conclusions Cost-benefit and operational feasibility of point-of-care testing needs to be assessed This will inform how to balance future investment in POC vs laboratory-based testing