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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.