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U.S. gFOBT Market Size Estimate Overall US gFOBT use numbers per year are hard to find, even though it is known that hundreds of millions of kits per year are made in the US.
One reason for this is that for decades gFOBT kits were not billed, and only recently in the last 5-10 years have hospitals finally improved their QC & established POCT oversight in following Joint Commission standards to control POC test kits. Hospitals want to be able to bill for all POCT kits, so there has been customer demand on POCT manufacturers to produce high quality kits which can be used & billed easily.
Hospitals are not particularly interested in advertising that they are not or were not in JC compliance. There are a good number of articles in the POCT literature talking about “illegal”, “underground”, “rogue” “unauthorized” & “hidden” POC testing, so the problem was and apparently still is widespread and acknowledged. Hospitals in the last decade have now set up POCT Coordinators who establish systems, training, and monitoring of POC tests to maintain quality standards.
The most complete set of data from a large hospital/clinic system comes from the Univ. of Texas Medical Branch in a presentation from 2004 which can be found by searching for “end2.pdf” on the site www.archive.org (or Google for HTML text only). UTMB has done a superb job of getting its POCT QC systems up to a high level of quality with the efforts of their large POC Testing group starting in 1999.
UTMB data summarized for POCT kits:
1. Inpatient, Outpatient, ER visits reported = 800,000 per year (in 6 hospitals and 2 dozen outpatient facilities); page 6 2. Total Volume of POCT = 1.2 million kits per year; page 8 3. Test Volume by Practice Type (waived tests): Occult Blood = 550,000 tests/yr; page 10 Conclusion: UTMB used 3 POC FOBT tests for every 2 admissions/visits Extrapolating for hospitals with 100 beds & up yields 350-550 million
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