A study of results generated using the Abbott LCx-GC assay fails to reveal a performance-based rationale for the 2002 level 1 recall.

Abstract

To establish the effect of a quality control failure on the performance of the LCx-GC nucleic-acid amplification assay for Neisseria gonorrhoeae (Abbott Laboratories, Abbott Park, IL) in the field, we conducted a retrospective analysis comparing the clinical and analytic performance of the recalled lots with those not implicated in the recall. Our analysis revealed no statistically significant differences between recalled lots (n = 8,686 tests) and nonrecalled lots (n = 8,699 tests) with respect to multiple parameters of assay performance, including frequency distribution of patient results (P = .575), prevalence of indeterminate results (P = .245), mean positive control signals (P = .26), and within-run calibrator precision (P = .68). The LCx-GC system's lack of an electronic data storage and retrieval capability prevented assessment of the impact of the quality control failure on the clinical performance of recalled lots, such as the one described herein, from being conducted in real time.