GEM Premier 5000

"In conclusion, the EG-i30 system demonstrates clinical performance equivalent to the ABL90 FLEX, showing excellent correlation and diagnostic accuracy across all key parameters. With bias levels well within acceptable medical limits, the EG-i30 serves as a reliable, maintenance-free, and cost-effective solution for rapid point-of-care testing in emergency and critical care settings."

"Artifactual hyperlipidemia caused by contamination with exogenous lipids can have a clinically significant impact on blood gas analysis. Manufacturers of blood gas analyzers must be persuaded to develop new instruments equipped with serum indices."

"A one-hour transport at room temperature is compatible with the performance of all the analyses studied except lactate. If the delay exceeds 30 min, the sample should be placed at +4 °C for lactate measurement. If the samples are stored in ice, it is important to note that the pO2 cannot be interpreted."

"The algorithm in the GEM®PremierTM series of analyzers that flags specimens at risk for glucose under-recovery due to low pO2 does not reliably detect specimens at risk for glucose under-recovery."

"Total pre-analytic and transient errors detected by IntraSpect were 1.91% worldwide. iQM2 with IntraSpect technology provides a unique control function detecting transient errors that would otherwise go undetected with traditional QC. Together with the statistical QC technology in iQM2, pre-analytic, analytic, and transient analytic errors are detected much faster - seconds versus hours - than by traditional statistical QC."

"This study effectively translates previous laboratory findings into clinical practice, highlighting the practical utility of PIs to guide the accurate interpretation of bedside ctHb measurements [GEM 4000 and GEM 5000 (Werfen GmbH), ABL90 Flex plus (Radiometer GmbH), HemoCue Hb 201+ (HemoCue), and XN 9000/9100 (Sysmex Deutschland GmbH)]" under acute care conditions."

"Clinically important systematic differences in sO2 measurement exist between GEM and ABL blood analyzers that perform co-oximetry, with potential implications for patient care and pulse oximeter verification studies. Larger studies with more co-oximeter brands, coupled with blood tonometry, are needed to better characterize these findings. In the meantime, regulatory standards and reports of pulse oximeter clinical trials should account for these findings and specify which manufacturer's co-oximeters were used."

The i-SmartCare 10 showed acceptable performance compared to major POC analyzers (ABL90 FLEX PLUS, i-Stat, RapidLab 1265, pHOx Ultra, and Gem Premier 5000). Despite some interferences and minor deviations in error limits, it is reliable for clinical use, provided a single platform is used consistently for monitoring to avoid inter-device bias.

"The Nova StatStrip glucometer was accurate in patients undergoing major upper abdominal surgery, independent of the administration of high-dose insulin therapy [in comparison with the GEM® PremierTM 5000 blood gas analyzer]"

"Considering the overall analytical performance observed, the ease of use of the system, the rapid time-to-results and the innovative Intelligent Quality Management technology (iQM2®), GP5000 seems suitable to be used in clinical care for safe patient management. Additionally, effective sample mixing upon draw and before analysis is strongly advisable in order to ensure the most clinically reliable BGA results."

"The precision and accuracy of the BGA improved significantly compared to those before management, indicating significant advantages of intelligent quality management in quality management applications."

"We advocate the use of BGA for sodium, potassium, and Hb measurement in emergency settings for quick decision-making. However, glucose measurements from BGA require careful interpretation and should be supplemented with laboratory testing."

"The findings in this study demonstrate excellent performance of the GEM Premier 5000 with iQM2 including >6 sigma precision for all analytes and faster error detection times. These benefits address risk in different phases of testing that are not easily detected by intermittent performance of liquid QC (manual or automated)."

"Identification of sample errors from pre-analytical sources, such as interferences and automatic corrective actions, along with the analytical performance, ease of use and low maintenance time of the instrument, makes the evaluated instrument a suitable blood gas analyzer for both POCT and laboratory use."