In an extension of the concept
of bringing the test near to the
patient
Sphere Medical
have
introduced the Proxima system - a
patient dedicated arterial blood
analyser for use in the ICU and
OR. A disposable multi-parameter
microanalyser is integrated into
an existing arterial or venous line on the patient.When a reading is
required, blood is withdrawn from the patient into the device and
a panel of analytes is measured to laboratory analyser accuracy. All
blood is returned into the patient after the measurement.
When enacting CLIA Congress recognized there were certain tests
which could be performed with little danger of harm to the patient
even if performed incorrectly, were simple and easy to use, or ap-
proved by the U.S. Food and Drug Administration for home use.
Perhaps the most widely used home
diagnostic test is the pregnancy test
which identifies human chorionic gona-
dotropin in the urine.
In the 1980’s
Medisense,
also acquired by
Abbott,
introduced a home based blood
glucose monitor, which has revolutionised
diabetic care. An estimated 285 million peo-
ple had diabetes around the world in 2010,
about 90% being type 2 diabetes; annual
sales of glucose biosensors is in the $billions.
There are many other home diagnostic tests on the market for, e.g.
chlamydia, cholesterol, allergies and genetic profiling. Many of these
tests are of unproven reliability or clinical value.
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