Diagnostic Analyzer May Be Used in Physician's Offices

A small hand-held analyzer is used for the simultaneous measurement of sodium, potassium, chloride, total carbon dioxide, glucose, urea, creatinine, ionized calcium, and hematocrit in arterial, venous, and capillary whole blood samples for the purpose of monitoring and diagnosing a patient's metabolic condition.

Weighing only 510 g, the i-STAT system is an easy-to-use, hand-held analyzer capable of providing time-sensitive test results at the patient's side in just minutes. To perform a test, the user places two or three drops of whole blood on the test cartridge, which is then inserted into the analyzer. A new test cartridge is used for each patient.

Abbott Point of Care (East Windsor, NJ, USA) announced that the U.S. Food and Drug Administration (FDA; Bethesda, MD, USA) has granted waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its handheld i-STAT CHEM8+ test cartridge, making it more widely available for use beyond the hospital setting. The waiver indicates the device is sufficiently simple and accurate and can be made more broadly available to healthcare providers where fast results are needed such as physicians' offices, emergency departments, intensive care units, operating rooms, catheterization labs, outpatient clinics, and military bases. By providing these critical test results rapidly, health care providers can quickly monitor and effectively manage their patient's care.

"Obtaining CLIA-waived status for the CHEM8+ test underscores the high quality and reliability of i-STAT cartridge technology and expands its potential beyond the hospital setting, improving the quality of care,” said Greg Arnsdorff, vice president, Abbott Point of Care. "Taking advantage of i-STAT's near immediate test results, more physicians will be able to provide their patients with treatment options in one visit, eliminating the cost and hassle of a second appointment.”


Related Links:
Abbott Point of Care
U.S. Food and Drug Administration