Www.militaryblood.dod.milUNCLASSIFIEDwww.militaryblood.dod.milUNCLASSIFIED Evaluation of Rapid Screening Methods for Emergency Blood Collections CPT Robert.

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Evaluation of Rapid Screening Methods for Emergency Blood Collections CPT Robert Gates, USA Armed Services Blood Program Update 12 February 2008

Goal and Objectives Goal and Objectives Background Background Biokit evaluation Biokit evaluation Conclusion Conclusion Other Tests-preliminary results (RV 236) Other Tests-preliminary results (RV 236) Agenda

Goal Minimize TTD risk related to transfusion of freshly collected blood products in theatre

Objectives Rigorously evaluate the HCV and HBsAg rapid tests currently in use in theatre Assess all other candidate tests for future use

Background >250 freshly collected blood products are transfused into patients at US medical installations in OIF/OEF monthly Questionnaires and screening are either not performed or conducted in substandard fashion HIV, HCV, and HBV are rare but present in donors Rapid testing offers opportunity to mitigate risk

Biorapid Evaluation

Biorapid Evaluation Kit Insert Data Biorapid HCVBiorapid HBsAg Sensitivity.994 ( ) (N=176) “able to detect HBsAg concentrations of 5IU/ml or higher” Specificity.987 ( ) (N=472) “>98% in studies with blood donors’ samples” Storage Temp  C2-8  C Testing Temp.“Room Temp.” Sample TypesS, P, WBS, P Volume Needed25µl125µl

Biorapid Evaluation Gold Standard EIA +- Biorapid HCV Aggregate data from: WWHV301 PHV106 PHW804 Sensitivity =.281 ( ) Negative Likelihood Ratio (LR-) =.719 Specificity = 13/13 = 1.00 ( )

Biorapid Evaluation Gold Standard EIA +- Biorapid HBsAg Aggregate data from: PHA106 PHA206 PHA808 Sensitivity =.157 ( ) Negative Likelihood Ratio (LR - ) =.843 Specificity = 8/8 = 1.00 ( )

HCV HBV

Biorapid Evaluation Gold Standard EIA +- Biorapid HCV Aggregate data from: American Red Cross samples Roberson Donor Center samples Sensitivity =.84 ( ) Negative Likelihood Ratio (LR-) =.16 Specificity = 13/13 = 1.00 ( )

Biorapid Evaluation Gold Standard EIA +- Biorapid HBsAg Aggregate data from: American Red Cross samples Roberson Donor Center samples Sensitivity =.875 ( ) Negative Likelihood Ratio (LR - ) =.125 Specificity = 8/8 = 1.00 ( ) * 18 Invalid tests

Conclusions Biorapid Evaluation Biorapid preformed poorly against panel specimens, but had no invalid results Also poor against clinical samples (84% sensitivity for HCV, 87.5% sensitivity for HBsAg) and had an 18% invalid rate with the HBsAg test Conclusion: Biorapid hepatitis rapid tests should be replaced by tests that perform better

RV 236 Seeks to identify best rapid assays for HCV and HBsAg Tests selected based on published material, paring down from 30 HBsAg, and 29 HCV to 6 HCV and 4 HBsAg Positive plasma down selection (N=50 per test) complete Selected tests will be challenged in three stages: -commercial panels (N = 54) -clinical samples (N = 672) -whole blood spiked with reactive plasma (N = 168) Ease of Use Survey

* Sensitivity statistically superior Compared to Biorapid * * * *

HCV Test Invalid Rate

EOU Breakdown (HCV)

EOU Breakdown (HCV)

EOU Breakdown (HCV)

EOU Breakdown (HCV)

DOWN SELECTION TEST DATA (HCV) Rapid AssayObserved Sensitivity (%), 95% CI * Thermo stability (  C) Overall Ease of Use Run Time (Minutes) OraSure(OraQuick)100, Up to AT FIRST (FIRST VUE)100, ALFA (Instant View)100, Axiom (axiom HCV)98, Core (Core HCV)98, MedMira (MiraWell)100**, Biokit (Biorapid)84,  C/RT N/A15 *Sensitivity based on small sample group (n=50),** 7/50 invalids (14%)

HBsAg Test Invalid Rate

EOU Breakdown (HBsAg)

EOU Breakdown (HBsAg)

EOU Breakdown (HBsAg)

EOU Breakdown (HBsAg)

PRELIMINARY DOWN SELECTION TEST DATA (HBsAg) Rapid AssayObserved Sensitivity (%), 95% CI * Thermo stability (  C) Overall Ease of Use Run Time (Minutes) AT FIRST (FIRST VUE)92, Axiom (Axiom HBsAg)84**, Core (Core HBsAg)90, MINERVA98***, Biokit (Biorapid)*87.5****, /RTN/A15 *Sensitivity based on small sample group (n=50),** 1/50 invalid (2%),***3/50 invalid (6%),****18/100 invalid (18% based on n=100)

Questions