Abbott announced that the US Food and Drug Administration (FDA) has granted waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for five additional test cartridges used by its i-STAT handheld blood analyzer.
Cartridges for E3+, EC4+ and 6+ aid the clinician in assessing a patient's metabolic state within a few minutes. The glucose cartridge quickly delivers a patient's diagnostic blood glucose level. Creatinine is a measure and indicator of a patient's renal function right at the patient's side. The five are components of the CHEM8+ cartridge, which the FDA waived in 2007. The CHEM8+ cartridge allows a clinician to run a basic chemistry panel on a patient together with haemoglobin and hematocrit tests. Waived status makes these tests more widely available for use beyond the hospital setting, for example in a physician's office or outpatient clinic.
"These additional CLIA waivers underscore the high quality and reliability of i-STAT cartridge technology and expand its potential beyond the hospital setting," said Greg Arnsdorff, vice president, point of care diagnostics, Abbott. "As these tests now become increasingly available in physicians' offices, more physicians will be able to provide their patients with treatment options in one visit, thereby improving the quality of care and eliminating the cost and hassle of a second appointment."
The CLIA waivers indicate that these test cartridges are simple and accurate and can be made more broadly available to healthcare providers where fast results are needed such as physicians' offices, outpatient clinics, imaging centers, catheterization labs, as well as emergency departments, intensive care units, operating rooms, and military bases. By providing these critical test results rapidly, health care providers can quickly monitor and effectively manage their patients' care.
The i-STAT System accelerates the availability of critical test information that clinicians require to make rapid triage and treatment decisions when diagnosing a patient's condition or monitoring a patient's treatment response.