Sanitary swab collection system, microfluidic assay device, and methods for diagnostic assays

A method for collecting a test sample, the method comprising:

• a) providing a sample collection device comprising:
• i) a body having an external surface, the external surface defining at least one swab receiving orifice with internal hollow volume for receiving a swab, the swab receiving orifice compatible with a sealable closure that may be sealably closed over the swab receiving orifice;
• and
• ii) a removable disposable external skin layer or shell covering at least a portion of the external surface of the body;
• and
• b) providing instructions comprising
• i) inserting the swab into the swab receiving orifice and sealably closing the sealable closure over the swab receiving orifice;
• ii) handling the sample collection device by contacting the external disposable skin layer or shell prior to or during insertion of the swab into the swab receiving orifice and closure of the sealable closure over the swab receiving orifice;
• iii) removing the removable disposable external skin layer or shell from the body with a clean hand after insertion of the swab into the swab receiving orifice and closure of the sealable closure over the swab receiving orifice, thereby exposing the at least a portion of the external surface of the body;
• and
• iv) handling the exposed external surface with clean hands, wherein the method reduces or eliminates contamination with a biohazard during sample collection or analysis.