Elementary School Students’ Performance With Two ELISA Test Systems

Daron Gale Ferris, Paul M. Fischer

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)766-770
Number of pages5
JournalJAMA: The Journal of the American Medical Association
Volume268
Issue number6
DOIs
StatePublished - Aug 12 1992

Fingerprint

Chorionic Gonadotropin
Enzyme-Linked Immunosorbent Assay
Students
Sensitivity and Specificity
Product Labeling
Centers for Medicare and Medicaid Services (U.S.)
Aptitude
Learning Curve
Streptococcus
Reading
Age Groups
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Elementary School Students’ Performance With Two ELISA Test Systems. / Ferris, Daron Gale; Fischer, Paul M.

In: JAMA: The Journal of the American Medical Association, Vol. 268, No. 6, 12.08.1992, p. 766-770.

Research output: Contribution to journalArticle

@article{561e6295a409452bae81e6996a7f92cc,
title = "Elementary School Students’ Performance With Two ELISA Test Systems",
abstract = "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.",
author = "Ferris, {Daron Gale} and Fischer, {Paul M.}",
year = "1992",
month = "8",
day = "12",
doi = "10.1001/jama.1992.03490060098031",
language = "English (US)",
volume = "268",
pages = "766--770",
journal = "JAMA - Journal of the American Medical Association",
issn = "0002-9955",
publisher = "American Medical Association",
number = "6",

}

TY - JOUR

T1 - Elementary School Students’ Performance With Two ELISA Test Systems

AU - Ferris, Daron Gale

AU - Fischer, Paul M.

PY - 1992/8/12

Y1 - 1992/8/12

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0026659950&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0026659950&partnerID=8YFLogxK

U2 - 10.1001/jama.1992.03490060098031

DO - 10.1001/jama.1992.03490060098031

M3 - Article

VL - 268

SP - 766

EP - 770

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0002-9955

IS - 6

ER -