Berry Bennett MPH, Retrovirology Section Chief, Florida Bureau of Laboratories
Sally Fordan BS, Retrovirology Supr., Florida Bureau of Laboratories
Background: In January 2004, the Florida Bureau of Laboratories, Retrovirology Unit, conducted a verfication process of the new BioRad HIV-1/HIV-2 Plus O EIA as a possible replacement for the BioRad HIV-1/2 Synthetic Peptide EIA as the primary screening assay for blood specimens. Manufacturer’s anticipation of an eventual assay replacement was the primary reason for the evaluation.
1) To conduct a comparative performance verfication between the two assays to satisfy our “in-house” requirements as well as CLIA’s new performance specifications, outlined in 42 CFR 493.1253.
2) In anticipation that the new screening assay is more sensitive than supplemental assays, use of molecular testing, if possible, and client follow up on non-confirmed repeatedly reactive screens may be required. Seroconversion panels may assist in sensitivity determinations.
Lessons Learned/Recommendations:
Communication between the laboratory and the manufacturer is essential to rule in or out automation, reagent or operator technique issues that may be associated with sensitivity or specificity issues.

Timely client follow up, in some public health settings, proves to be difficult to determine seroconversion in the time allowed for assay verifications. The use of molecular testing, provided an appropriate specimen was submitted, proves to be an asset

Last Update: April 8, 2005