Objective.
—To examine analytic performance by previously untrained and inexperienced subjects using enzyme-linked immunosorbent assay (ELISA) tests developed for decentralized laboratories. Performance variability between tests assigned to the "simple" and "moderately complex" Health Care Financing Administration laboratory levels was evaluated.
Design.
—A nonrandomized trial of the Surecell Strep-A chorionic gonadotropin ELISA tests. Each subject processed nine unknown specimens (three negative, three weakly positive, and three strongly positive) for each ELISA test. Subjects were blinded to expected test results.
Setting.
—An elementary school.
Subjects.
—A convenience sample of 52 students enrolled in the sixth and seventh grades. This age group was chosen because of their ability to generally comprehend instructions and remain attentive to the testing task.
Interventions.
—Subjects were either self-trained by reading package insert directions or trained by a manufacturer's sales representative.
Main Outcome Measures.
—Performance was measured as the percentage of correct test results for the unknown specimens. The sensitivity and specificity for each test by operator group were calculated.
Results.
—Subjects demonstrated an overall sensitivity of 97.1% and specificity of 94.7% for human chorionic gonadotropin unknown specimens and a 95.9% sensitivity and 96.8% specificity for group A steptococcus unknown specimens. No significant differences between the self-trained group and the representative-trained group were observed for either group A streptococcus or human chorionic gonadotropin tests. Performance was so high with the first specimen that improvement over time (ie, a "learning curve") could not be demonstrated.
Conclusion.
—These ELISA test systems are able to achieve high levels of performance by subjects with no formal laboratory background, no previous method specific experience, and limited self-training.
(JAMA. 1992;268:766-770)
