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==Diagnosis== The current [[clinical case definition]] of diphtheria used by the [[United States]]' [[Centers for Disease Control and Prevention]] <!-- (CDC) --> is based on both laboratory and clinical criteria. ===Laboratory criteria=== * Isolation of ''C. diphtheriae'' from a Gram stain or throat culture from a clinical specimen.<ref name="MedlinePlusEncyclopedia Diphtheria"/> * Histopathologic diagnosis of diphtheria by Albert's stain. ===Toxin demonstration=== * In vivo tests (guinea pig inoculation): Subcutaneous and intracutaneous tests.{{citation needed|date=March 2023}} * In vitro test: Elek's gel precipitation test, detection of tox gene by PCR, ELISA, ICA. ===Clinical criteria=== * Upper respiratory tract illness with sore throat. * Low-grade fever (above {{convert|39|C|F}} is rare). * An adherent, dense, grey pseudomembrane covering the posterior aspect of the pharynx; in severe cases, it can extend to cover the entire tracheobronchial tree. ===Case classification=== * Probable: a clinically compatible case that is not laboratory-confirmed, and is not epidemiologically linked to a laboratory-confirmed case. * Confirmed: a clinically compatible case that is either laboratory-confirmed or epidemiologically linked to a laboratory-confirmed case. Empirical treatment should generally be started in a patient in whom suspicion of diphtheria is high.
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