Page 4 - Sensor100 Jan '13

Point of Care Diagnostics
In 1988, the US enacted the Clinical Laboratory Improvement
Amendments (CLIA) legislation, which required laboratories under-
taking diagnostic testing on human patients to meet certain quality
standards. It had a huge effect on US laboratory medicine, and many
smaller labs associated with doctors’ offices or privately run were
closed when it was found uneconomic to meet the quality standards
required. As a result, hospital and large private laboratories now
provide these diagnostic services using highly automated systems;
current market leaders include Siemens Healthcare and Roche
Diagnostics.
At the same time as hospital laboratories were becoming centralised
and automated, it was recognised that there was a need for some
tests to be performed on a “stat” i.e. urgent basis. It was prefer-
able to bring the testing nearer to the patient instead of waiting for
sample transport to a distant central laboratory, whose sense of
urgency may not have been the same as the clinician at the patient’s
bedside. This resulted in the introduction of “satellite” labs in hos-
pitals, often adjacent to the ICU or OR, where urgent tests such as
blood gas analysis could be conducted rapidly. Radiometer was an
early player in this market with their automated blood gas analysers.
Gradually more tests were added to these systems, such as blood
electrolytes.
In 1987 i-Stat, since acquired by Ab-
bott Point of Care, was introduced,
providing a range of blood gas, electro-
lyte, hematology, chemical and other
tests in a hand held instrument which
now dominates the PoC market.