Let the user beware: specificity and sensitivity limits for in vitro diagnostic devices.
Levine
D
D
New England Pediatrics LLP, 166 West Bond St., Suite 103, Stamford, CT 06902, USA.
Klenk
R
R
Morelli
A
A
Hofreuter
N
N
Hoffmeister
H
H
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
D011933:Reagent Kits, Diagnostic