CHEM8+ Test Cartridge Receives CLIA Waiver
Abbott announced that their i-STAT CHEM8+ test cartridge received a CLIA waiver from the FDA, according to a report from the Healthcare Sales and Marketing Network. As the test name insinuates, reliable results are delivered quickly. This enables use of the diagnostic test outside of facilities with laboratory departments as well as on site in such places as the emergency room, ICU, and operating theater.
The CHEM8+ test cartridge for in vitro diagnostic testing includes a profile of standard chemistry tests, including sodium, potassium, chloride, total carbon dioxide, glucose, urea, creatinine, and ionized calcium, plus hematocrit levels. Samples from venous, arterial, or capillary whole blood can be used with the cartridge.
The i-STAT System is a simple, handheld blood analyzer that provides rapid test results and is designed for use at the bedside. Testing requires two to three drops of the blood specimen, placed directly onto the requisite cartridge. The cartridge is then loaded into the i-STAT for analysis.
Access to this data rapidly enables clinicians to accelerate the diagnostic process. In the outpatient setting, it can mitigate the need for a follow-up visit after the laboratory has completed blood analysis. In critical care environments such as the cardiac catheterization lab and intensive care unit, rapid access to information can immediately guide critical decision making in a more timely manner than running samples to the hospital’s laboratory.
A new cartridge is used with each patient. The cartridges are test specific and entirely self-contained. The CHEM8+ is the first in the Abbott i-STAT line to receive a CLIA waiver.
October 3, 2007 Related topics: Laboratory, Laboratory Equipment, Emergency