Time to Critique the Paradigm: “If no Specimen is Collected, it is not a Laboratory Test”

Author(s): Professor. Gurmukh Singh

The current paradigm for laboratory tests holds that if a specimen is not collected, the diagnostic test is not a laboratory test. College of American Pathologists does not include such diagnostic testing in its accreditation program. However, there are increasing number of diagnostic tests that are being conducted on exhaled breath, and by transcutaneous measurements. Miniaturization of mass-spectrometry equipment has the potential to broaden the range of breath analysis to monitor the course of disease, without collecting specimens. Multiphoton imaging of skin and accessible mucus membranes can provide histologic grade resolution of lesions without collecting a specimen. Improvements in magnetic resonance imaging has the potential to increase the resolution to light microscopy level detail. It would be prudent for the pathology national organizations to address this issue and plan for the upcoming advancements in diagnostic testing without collecting specimens.

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