title: Let the user beware: specificity and sensitivity limits for in vitro diagnostic devices.
authors.affiliation: New England Pediatrics LLP, 166 West Bond St., Suite 103, Stamford, CT 06902, USA.
authors.forename: D
authors.initials: D
authors.lastname: Levine
authors.forename: R
authors.initials: R
authors.lastname: Klenk
authors.forename: A
authors.initials: A
authors.lastname: Morelli
authors.forename: N
authors.initials: N
authors.lastname: Hofreuter
authors.forename: H
authors.initials: H
authors.lastname: Hoffmeister
mesh_terms: D018795:Device Approval; D005189:False Positive Reactions; D006801:Humans; D066298:In Vitro Techniques; D007244:Infectious Mononucleosis / Q000175:diagnosis*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011933:Reagent Kits, Diagnostic