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ABBOTT ARCHITECT ANTI-HCV –
VALIDATION OF CADAVERIC CLAIM
Leeman C; Galvin E; Cornwall J; Marland E; Repousis S; Vrhovsek E;
Harkness J
Serology Department – SydPath St Vincent’s Hospital Darlinghurst NSW 2010
Background and Aim
 cGMP Lab:
- Cadaveric blood
- Donor supply
 Abbott Diagnostics:
- Mandatory screening
assay, Cadaveric
testing claim
 Verified:
- FDA Guidance
Document
- “Guidance for Industry”
Materials
Patient Samples:
 Serology collected pre- and
post-mortem paired samples
 Stored at <-20’C
 Thawed, Vortexed,
Centrifuged 10,000g/10min
 Donors 10 - 85 years
 DOB’s, collection dates
 Bio-Rad Viraclear #00107,
spiking
Statistical Analysis:
 Mean & Standard
Deviation of signal
response
 2-Tailed Student t-test,
<0.05 is considered
significant.
Methods
Clinical Specificity:

Determine if a statistically significant
difference exists between pre- and
post-mortem specimens based on
frequency of false positive results.
Analytical Specificity:


Determine if a statistically significant
difference exists between pre- and
post-mortem specimens based on
signal strength.
Assessed using 58 pairs of preand
post-mortem samples.
Sensitivity:






Recommended to test at least 50 pairs
of non reactive cadaver specimens.
Specimens spiked with hepatitis C
near to the assay’s cut off.
Minimum of 5 individual sources.
Spiked specimens run on Abbott
Architect.
Mean and SD of both populations
calculated.
2-Tailed Student t-test
Results:
Clinical Specificity:
 All 58 pairs non reactive using the
Hepatitis C assay.
 No false reactive specimens.
Analytical Specficity:
 Pre- and post-mortem results
calculated giving a result of p= 0.083.
 Statistically insignificant.
 No statistical difference between the 2
populations.
Sensitivity:
2-Tailed Student t-test used to determine
if a statistically significant difference exists
based on signal strength.
Mean and SD calculated.
Results suggest no statistically significant
difference between the spiked pre- and
post-mortem specimens.