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![Page 1: Www.militaryblood.dod.milUNCLASSIFIED Evaluation of Rapid Screening Methods for Emergency Blood Collections CPT Robert](https://reader030.vdocuments.us/reader030/viewer/2022032703/56649d1f5503460f949f3ef2/html5/thumbnails/1.jpg)
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Evaluation of Rapid Screening Methods for Emergency
Blood Collections
CPT Robert Gates, USACPT Robert Gates, USAArmed Services Blood Program Update Armed Services Blood Program Update
12 February 200812 February 2008
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• Goal and ObjectivesGoal and Objectives• BackgroundBackground• Biokit evaluationBiokit evaluation• ConclusionConclusion• Other Tests-preliminary results (RV 236)Other Tests-preliminary results (RV 236)
Agenda
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Goal
Minimize TTD risk related to transfusion of Minimize TTD risk related to transfusion of freshly collected blood products in theatrefreshly collected blood products in theatre
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Objectives
• Rigorously evaluate the HCV and HBsAg rapid tests currently in use in theatre
• Assess all other candidate tests for future use
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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
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Biorapid Evaluation
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Biorapid EvaluationKit Insert Data
Biorapid HCV Biorapid HBsAg
Sensitivity .994 (.969-.999)
(N=176)
“able to detect HBsAg concentrations of 5IU/ml or higher”
Specificity .987 (.973-.995)
(N=472)
“>98% in studies with blood donors’ samples”
Storage Temp. 2-25C 2-8CTesting Temp. “Room Temp.” “Room Temp.”
Sample Types S, P, WB S, P
Volume Needed 25µl 125µl
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Biorapid Evaluation
Gold Standard EIA
+ -
Biorapid HCV
+ 9 0
- 23 13
32 13
Aggregate data from:WWHV301PHV106PHW804
Sensitivity = .281 (.138-.468)
Negative Likelihood Ratio (LR-) = .719
Specificity = 13/13 = 1.00 (.794-1.00)
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Biorapid Evaluation
Gold Standard EIA
+ -
Biorapid HBsAg
+ 8 0
- 43 8
51 8
Aggregate data from:PHA106PHA206PHA808
Sensitivity = .157 (.070-.286)
Negative Likelihood Ratio (LR-) = .843
Specificity = 8/8 = 1.00 (.688-1.00)
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HCV HBV
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Biorapid Evaluation
Gold Standard EIA
+ -
Biorapid HCV + 42 0
- 8 50
50 50
Aggregate data from:American Red Cross samplesRoberson Donor Centersamples
Sensitivity = .84 (.709-.928)
Negative Likelihood Ratio (LR-) = .16
Specificity = 13/13 = 1.00 (.929-1.00)
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Biorapid Evaluation Gold Standard EIA
+ -
Biorapid HBsAg
+ 35 0
- 5 42
40 42
Aggregate data from:
American Red Cross samples
Roberson Donor Center
samples
Sensitivity = .875 (.730-.889)
Negative Likelihood Ratio (LR-) = .125
Specificity = 8/8 = 1.00 (.916-1.00)
* 18 Invalid tests
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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
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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
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0102030405060708090
100
% Sensitivity
OraSure Alfa AT First Axiom CORE MedMira
Rapid test
Observed Sensitivity HCV Test
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* Sensitivity statistically superior Compared to Biorapid
0102030405060708090
100
% Sensitivity
OraSure Alfa AT First Axiom CORE MedMira BIORAPID
Rapid Test
Observed Sensitivity
* * *
*
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HCV Test Invalid Rate
0102030405060708090
100
% In
valid
Ora
Qu
ick
Alf
a
Axio
m
At
Fir
st
Co
re
Med
mir
a
Rapid Test
Observer 1
Observer 2
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EOU Breakdown (HCV)
1
2
3
4
5
Score
OraSure Alfa AT First Axiom CORE MedMira
Rapid kits
EOU HCV Reading
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EOU Breakdown (HCV)
1
2
3
4
5
Score
OraSure Alfa AT First Axiom CORE MedMira
Rapid kits
EOU HCV Interpreting
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EOU Breakdown (HCV)
1
2
3
4
5
Score
OraSure Alfa AT First Axiom CORE MedMira
Rapid Kits
EOU HCV Learning
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EOU Breakdown (HCV)
1
2
3
4
5
Score
OraSure Alfa AT First Axiom CORE MedMira
Rapid Kits
EOU HCV Overall
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DOWN SELECTION TEST DATA (HCV)
Rapid Assay Observed Sensitivity (%), 95% CI *
Thermo stability (C)
Overall Ease of Use
Run Time (Minutes)
OraSure(OraQuick) 100, 94.2-100. Up to 30 5 20
AT FIRST (FIRST VUE) 100, 94.2-100 4-30 4 10
ALFA (Instant View) 100, 94.2-100 15-30 4 10
Axiom (axiom HCV) 98, 89.4-99.9 2-30 4 10
Core (Core HCV) 98, 89.4-99.9 4- 30 3 15
MedMira (MiraWell) 100**, 93.3-100 2-30 2 3
Biokit (Biorapid) 84, 70.9-92.8 2-25C/RT N/A 15
*Sensitivity based on small sample group (n=50),** 7/50 invalids (14%)
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0
10
20
30
40
50
60
70
80
90
100
% Sensitivity
At First Axiom CORE Minerva
Rapid Test
Observed Sensitivity HBsAG Test
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Observed Sensitivity
0102030405060708090
100
At First Axiom CORE Minerva BIORAPID
Rapid Test
% Sensitivity
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HBsAg Test Invalid Rate
0102030405060708090
100
% In
valid
Min
erva
Co
re
Axi
om
At
Fir
st
Rapid Test
Observer 1
Observer 2
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EOU Breakdown (HBsAg)
1
2
3
4
5
Score
At First Axiom CORE Minerva
Rapid Kits
EOU HBsAg Reading
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EOU Breakdown (HBsAg)
0
1
2
3
4
5
Score
At First Axiom CORE Minerva
Rapid Kits
EOU HBsAg Interpreting
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EOU Breakdown (HBsAg)
1
2
3
4
5
Score
At First Axiom CORE Minerva
Rapid Kits
EOU HBsAg Learning
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EOU Breakdown (HBsAg)
1
2
3
4
5
Score
At First Axiom CORE Minerva
Rapid Kits
EOU HBsAg Overall
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PRELIMINARY DOWN SELECTION TEST DATA (HBsAg)
Rapid Assay Observed Sensitivity (%), 95% CI *
Thermo stability (C)
Overall Ease of Use
Run Time (Minutes)
AT FIRST (FIRST VUE) 92,80.8-97.8 4-30 5 15
Axiom (Axiom HBsAg) 84**,70.3-92.7 2-30 4 15
Core (Core HBsAg) 90,78.2-96.7 4-30 4 15
MINERVA 98*** ,88.7-99.9 15-34 4 15
Biokit (Biorapid)* 87.5****, 73-88.9 2-8/RT N/A 15
*Sensitivity based on small sample group (n=50),** 1/50 invalid (2%),***3/50 invalid (6%),****18/100 invalid (18% based on n=100)
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Questions
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0
1
2
3
4
5
OraSure(OraQuick)
Alfa( Instantview)
AT First(FIRST VIEW)
Axiom CORE MedMira (MiraWell)
Test Kits
Ease of use survey (HCV)
QUESTION 4
QUESTION 5
QUESTION 6
QUESTION 9
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0
1
2
3
4
5
AT First (FIRST VIEW) Axiom CORE Minerva (Vscan)
Test kits
Ease of use survey (HBsAg)
QUESTION 4QUESTION 5QUESTION 6QUESTION 9