Prioritizing Life-Saving Point-of-Care (POC) Diagnostics in the Aftermath of an Outbreak. Global Health Mini University March 4, 2016

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Phillip Shepherd
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1 Prioritizing Life-Saving Point-of-Care (POC) Diagnostics in the Aftermath of an Outbreak Global Health Mini University March 4, 2016

2 The following materials are based upon personal experiences working as part of an Ebola emergency response team Nov 2014 Feb The information presented herein does not imply the expression of any opinion whatsoever on the part of any governmental, non-governmental or multilateral entity.

3 Ebola Outbreak Response SIERRA LEONE NOV 26, 2014

4 Source: WHO Ebola Response Roadmap Situation Report 26 November 2014 retrieved 2 February 2016 from:

5 Source: WHO Ebola Response Roadmap Situation Report 26 November 2014 retrieved 2 February 2016 from:

6 Source: WHO Ebola Response Roadmap Situation Report 26 November 2014 retrieved 2 February 2016 from:

7 Community Care Center (CCC) Established at source by local chief Early patient isolation Isolation within local community Sickest patients transferred for higher level care Considerations Staffing Training PPE Diagnostics

8 Diagnostics Reliable and rapid diagnostics are critical during an outbreak Point of care (POC) tests Molecular laboratory-based tests Special considerations Regulatory requirements Biosafety Quality of users and sites Finance and investment

of working in an outbreak situation? How does the challenges impact patient care?

9 Your Mission You will have been given a character as you entered the room: Student nurse Patient Phlebotomist / Laboratory Technologist In your role consider the following: What are the challenges of working in an outbreak situation? How does the challenges impact patient care? How can the quality of diagnostic testing can be improved? What are the advantages and disadvantages of POC vs molecular testing?

10 CCC INTERACTIVE STATIONS

11 CCC, Scenario: Molecular testing of suspected Ebola sample Draw blood via venipuncture from a suspected Ebola patient Package sample for shipment to a reference laboratory for molecular testing

12 CCC, Scenario: Point of Care Testing Rapid Diagnostic Testing of suspected Ebola sample Draw blood via fingerpick from a suspected Ebola patient Perform Point-of-Care (POC) Diagnostics

13 Activities DONNING, PHLEBOTOMY, TESTING & SAMPLE REFERRAL

14 Donning PPE Note that this session focuses on diagnostic challenges during an emergency outbreak situation We do not have time to demonstrate proper donning and doffing! We have 3 sets of PPE, 1 for each of the following staff: Triage nurse Nurse Phlebotomist GSSHealth team members will assist you to put on your PPE Note that the supplies we are using are identical to supplies used in the field.

15 Phlebotomy Note: Highly trained phlebotomists were in short supply and in particular need as cases climbed. Appropriate blood collection supplies were not always available. Group 1 will collect samples using a finger-stick (finger-prick) technique Group 2 will collect samples via venipuncture GSSHealth team members will assist you to perform sample collection *Note that we not collecting human samples and are using colored dye as fake blood!*

16 Testing and Sample Referral Note: a true point of care test was not available at the time of CCC scale-up. POC tests for Ebola are still under development. Group 1 will use a rapid diagnostic test (RDT) in the CCC Group 2 will package the blood sample for shipment to another laboratory for molecular testing GSSHealth team members will assist you to perform these tasks

17 DISCUSSION

Public domain copyright: CDC. (2011). Retrieved from: http://phil.cdc.

18 Discussion Points: Sample Collection What challenges did staff face when collecting the sample? What safety issues exist when collection samples in this setting? Public domain copyright: CDC. (2011). Retrieved from: Public domain copyright: CDC. Retrieved from:

19 Discussion Points: Sample Testing Did you find it easy to perform the test? What external factors could have influenced your test results? What safety issues exist when performing tests in this setting? From ReEBOVTM Antigen Rapid Test (Ebolavirus VP40 Antigen Detection) Instructions for Use ftp://ftp.corgenix.com/intra/reebov/14005.pdf

Discussion Points: Result Interpretation Was it easy to understand the instructions on how to interpret results? Where the test results clear?

20 Discussion Points: Result Interpretation Was it easy to understand the instructions on how to interpret results? Where the test results clear? Were you able to easily interpret your test results? From ReEBOVTM Antigen Rapid Test (Ebolavirus VP40 Antigen Detection) Instructions for Use ftp://ftp.corgenix.com/intra/reebov/14005.pdf

21 CONCLUSIONS

22 Conclusion POC diagnostic testing during infectious disease outbreaks can greatly improve the time to diagnosis Quality of POC tests and entire process is critical to ensure that patients are diagnosed quickly and accurately, for proper care and treatment Proper PPE must be procured and used Regulatory processes for new POC tests much be established to ensure they are safe, effective, affordable and appropriate for the outbreak R&D plays an important role in development of new POC diagnostics

Selection and use of Ebola in vitro diagnostic (IVD) assays

EMERGENCY GUIDANCE Selection and use of Ebola in vitro diagnostic (IVD) assays June 2015 World Health Organization 2015. All rights reserved. The designations employed and the presentation of the material