Let the User Beware: Specificity and Sensitivity Limits for In Vitro Diagnostic Devices

Current regulations governing the approval process for medical devices appears to allow products to be marketed without being adequately tested. Doctors using a test kit called Monolert designed to detect patients with mononucleosis found a significant number of patients with false positive results....

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Bibliographic Details
Published in:Pediatrics (Evanston) 1997-08, Vol.100 (2), p.267-269
Main Authors: Levine, Dorothy, Klenk, Rosemary, Morelli, Alan, Hofreuter, Nancy, Hoffmeister, Hilary
Format: Article
Language:English
Subjects:
Biological and medical sciences
Device Approval
Diagnosis
False Positive Reactions
Humans
In Vitro Techniques
Infectious mononucleosis
Infectious Mononucleosis - diagnosis
Investigative techniques, diagnostic techniques (general aspects)
Laws, regulations and rules
Marketing
Medical equipment and supplies industry
Medical equipment industry
Medical sciences
Medical screening
Medical test kit industry
Medical tests
Miscellaneous. Technology
Mononucleosis
Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques
Pediatrics
Product defects and recalls
Reagent Kits, Diagnostic - standards
Regulation
Sensitivity and Specificity
Tests
United States
United States Food and Drug Administration
Citations: Items that this one cites
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Summary:Current regulations governing the approval process for medical devices appears to allow products to be marketed without being adequately tested. Doctors using a test kit called Monolert designed to detect patients with mononucleosis found a significant number of patients with false positive results. Further investigation with the Food and Drug Administration was not productive. This particular product had never been scientifically tested but brought onto the market as a device similar to another tested product. Independent investigation should be warranted on questionable products or medications.
ISSN:0031-4005
1098-4275
DOI:10.1542/peds.100.2.267