title: 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.
authors.affiliation: Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis, USA.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Skeate
authors.forename: Monika M
authors.initials: MM
authors.lastname: Wahi
authors.forename: Kevan L
authors.initials: KL
authors.lastname: Hanson
authors.forename: Charles P
authors.initials: CP
authors.lastname: Cartwright
mesh_terms: D000818:Animals; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis*; D006801:Humans; D009344:Neisseria gonorrhoeae / Q000302:isolation & purification*; D021141:Nucleic Acid Amplification Techniques; D011785:Quality Assurance, Health Care; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity
chemical_list: D011933:Reagent Kits, Diagnostic