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Test code: 180.
Method: Polymerase chain reaction (PCR)-Qualitative.
Specimen requirements: SurePath: 1.0 mL (0.50 mL) minimum.
Collection and transport: SurePath: Store and ship at ambient temperature up to 28 days.
Causes for rejection: SurePath: Less than 0.50 mL and/or more than 28 days.
Specimen stability: SurePath: Stable for up to 28 days at room temperature.
Reference range: Not detected.
Clinical significance: The speed and enhanced sensitivity of the Roche amplified DNA probe methodology enables early, accurate detection of Neisseria gonorrhoeae, resulting in timely administration of therapy. Several publications involving multiple centers have demonstrated a sensitivity of greater than 97% sensitivity in the detection of gonorrhea. The specificity is greater than 99%.