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UNLESS: According to subpart K of good 'ol CLIA, any assay which has been
tested in house and proven to be equivalent to an FDA cleared assay may be
reported out as if it were itself FDA cleared. There are no specific
guidelines for performing this comparison. In the flow lab, other than
CD4's, HLA-B27's, and reticulocyte counts, I don't think much else
(cytometry related) has been FDA cleared, and thus must all carry a
disclaimer. i.e. If there is no FDA cleared equivalent assay, you will
always add a disclaimer.
In the past, I have used something like: "This assay is not by itself
diagnostic and must be used in conjunction with other clinical and
laboratory data when evaluating patient status". It states what it must
state while not signalling insurance guru's to refuse payment.
Then again, that's only my interpretation. I could be wrong.
good luck.
Keith Bahjat
Kbahjat@nwu.edu
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CD-ROM Vol 3 was produced by Monica M. Shively and other staff at the
Purdue University Cytometry Laboratories and distributed free of charge
as an educational service to the cytometry community.
If you have any comments please direct them to
Dr. J. Paul Robinson, Professor & Director,
PUCL, Purdue University, West Lafayette, IN 47907.
Phone: (765)-494-0757;
FAX(765) 494-0517;
Web