Evaluation Of Harmonization Across Siemens Healthineers Blood Gas .

Evaluation of Harmonization Across SiemensHealthineers Blood Gas Systems and theAtellica CH 930 Clinical Chemistry System forCommon MeasurandsSamantha Shum, BAa, Tina Umscheid, BS, MLT(ASCP)Cb, Sheryl Fennell, BS MT (ASCP)c, Jill A Sellers, BSPharm, PharmDdIntroductionAssessment and laboratory examinations are the primary methodused by clinicians to evaluate a patient’s condition and providea diagnosis. The ability to perform laboratory tests quickly andreceive accurate results allows for a more effective diagnosis,prognosis, and treatment plan. The development of point-ofcare testing (POCT) has revolutionized the way in which patientbiodata are sampled, analyzed, and reported. Convenient andeasy-to-use POCT devices have combined portability with theaccuracy of traditional laboratory analysis and instrumentation.1The turnaround time (TAT) from sample collection to test resulthas improved with POCT versus central laboratory testing, whichallows for a quicker diagnosis and initiation of therapy.2 TAT hasbeen the primary driving force behind the implementation ofPOCT devices.3 However, it is imperative that the POCT devicesprovide accurate results with minimal variability betweenportable and stationary devices, including those in the centrallaboratory. There are many types of POCT devices currently inexistence and use, including blood gas analyzers, to name onecategory.In the arena of blood gas analyzers, Siemens Healthineers offersthe following platforms: the epoc Blood Analysis System (forpatient-side testing), RAPIDPoint 500e Blood Gas System(designed for POC), RAPIDLab 1265 Blood Gas System (clinicallaboratory system), and RAPIDLab 348EX Blood Gas System(designed for lower-volume testing sites). Siemens Healthineersrecently introduced the Atellica Chemistry (CH) 930 Analyzer,a high-throughput clinical chemistry system based in the centrallaboratory. The need for correlation and harmonization amongthese devices (e.g., POCT and central laboratory testing) atclinically relevant decision points is of utmost importance,specifically as a patient transitions between levels of care.Healthcare providers expect consistent results for the samepatient sample when analyzed across various platforms andwith different measurement procedures. A previously performedScientist II, Assay Development, Siemens Healthcare Diagnostics Inc.,Norwood, Massachusetts. bScientist I, Assay Development, SiemensHealthcare Diagnostics Inc., Norwood, MA. cSenior Manager, AssayDevelopment, Siemens Healthcare Diagnostics Inc., Norwood, MA.dExecutive Director, Medavera, Inc., Springfield, Missouri. Productavailability varies by country. RAPIDLab 348EX Blood Gas System isnot available in the US. Atellica, epoc, RAPIDLab, RAPIDPoint, and allassociated marks are trademarks of Siemens Healthcare Diagnostics Inc.,or its affiliates. All other trademarks and brands are the property of theirrespective owners.a56study to determine correlation between Siemens Healthineersplatforms and a clinical chemistry system found comparableresults for the same patient sample.4 Harmonization at medicaldecision levels (MDLs) was demonstrated between the platformsstudied. Consistent and comparable results across platformsleave no room for misinterpretation and translate into confidentdiagnoses and appropriate treatments.To further investigate harmonization across its most currentclinical platforms, Siemens Healthineers conducted an internalstudy designed to assess the variability in results between theepoc, RAPIDPoint 500e, RAPIDLab 1265, RAPIDLab 348EX, andthe Atellica CH 930 systems.Instrument OverviewA brief description of the blood gas systems and clinicalchemistry system that were included in this study is providedbelow. It is important to understand the differences betweenthese systems and what they offer to the diagnostic assessment,particularly when these instruments are being directly comparedwith one another.RAPIDPoint 500e Blood Gas SystemSiemens Healthineers RAPIDPoint 500e system (Figure 1)is a point-of-care analyzer that measures pH, blood gases,electrolytes, glucose, lactate, and full CO-oximetry, providingpatient results in just 60 seconds on a single sample ofheparinized whole blood. The easy-to-use, cartridge-basedtechnology offers heightened operational simplicity whileleveraging Siemens Healthineers proprietary Integri-sense Technology to enable robust accuracy from sample to sampleand confidence in every result.The measurement cartridge resides on the system for upto 28 days, and the variety of cartridge test sizes availableaccommodates low- to high-volume test sites, making theRAPIDPoint 500e system ideal for both point-of-care andlaboratory settings. The sensors used in the RAPIDPoint 500esystem are miniaturized and planar chip in design and representan integral component of the RAPIDPoint measurementcartridge. The principal methodologies of the system includeamperometry, potentiometry, and spectrophotometry.Respiratory Therapy Vol. 16 No. 1 Winter 2021n

Figure 1. RAPIDPoint 500e Blood Gas System in an ICU.Figure 3. RAPIDLab 348EX Blood Gas System in a laboratory.RAPIDLab 1265 Blood Gas Systemepoc Blood Analysis SystemThe RAPIDLab 1265 analyzer (Figure 2) offers a similarcomprehensive menu and quick turnaround time for busyclinicians. By combining the longevity of Ready Sensor electrode technology with the efficiency and ease of cartridgebased reagents, the RAPIDLab 1265 system optimizesoperational performance in medium- to high-volume testing sites.The epoc Blood Analysis System (Figure 4) is a handheld,wireless solution that provides blood gases, a basic metabolicpanel, hematocrit and lactate test results at the patient bedside inless than 1 minute after sample introduction. By incorporating afull critical care menu, including creatinine and BUN, on a singleroom-temperature-stable test card, the epoc system delivers anefficient and easy-to-manage patient-side testing program for thehospital.The measurement module in the RAPIDLab 1265 systemcomprises individual sensors developed for selectivity to theanalyte of choice. Ready Sensor electrodes are aligned inthe measurement module of the RAPIDLab 1265 system andconstantly maintained at 37 C for optimum performance.Minimal sample volume requirements, advanced automaticquality control, fast calibration times, and hands-free, bio-safesampling help improve workflow wherever critical care testing isperformed.Figure 4. epoc Blood Analysis System at the patient-side.Atellica CH 930 Clinical Chemistry AnalyzerThe Atellica CH 930 Analyzer (Figure 5) is the ideal solutionfor mid- to high-volume sample analysis within the laboratory,with the ability to perform up to 1800 tests per hour. The fullyautomated system offers an extensive menu and high throughputto meet the turnaround time demands of the busiest laboratories.Figure 2. RAPIDLab 1265 Blood Gas System in the NICU.RAPIDLab 348EX Blood Gas SystemDesigned to deliver efficient critical care analysis in lowervolume testing sites, the RAPIDLab 348EX System (Figure3) is a robust, cost-effective solution for smaller laboratoriestasked with the challenge of performing fast-turnaround criticalcare tests. Fully automated operation supports low to mediumthroughput on an easy-to-use analyzer that is ready to generateaccurate, on-demand results when clinicians need them, with aminimum of operator involvement.Respiratory Therapy Vol. 16 No. 1 Winter 2021nFigure 5. Atellica CH 930 Analyzer in the central laboratory.57

Materials and MethodsThis study investigated the accuracy of whole blood analytemeasurement across the full Siemens Healthineers blood gasanalyzer portfolio compared to that of the RAPIDLab 1265system and to plasma analyte measurement for commonmeasurands on the Atellica CH 930 chemistry system.Two of each blood gas system were set up on individualbenches designated Bench #1 and Bench #2 and located inclose proximity at the Siemens Healthineers Edgewater facility(Table 1).Table 1. Blood gas analyzer bench setup.Bench #1RAPIDLab 1265 system #1RAPIDPoint 500e system #1RAPIDLab 348EX system(with chloride) #1RAPIDLab 348EX system(with ionized calcium) #1epoc system #1Bench #2RAPIDLab 1265 system #2RAPIDPoint 500e system #2RAPIDLab 348EX system(with chloride) #2RAPIDLab 348EX system(with ionized calcium) #2epoc system #2second replicate was evaluated and reported. The performanceof each system was verified daily with quality control materials,and the same lot numbers of reagents and sensors were used foreach platform type throughout the testing process.All measurement procedure comparisons were performedin accordance with the CLSI EP09c guideline.5 Correlationstatistics, including slope (m), intercept (b), and coefficient ofdetermination (r2) as determined by Ordinary Deming, WeightedDeming, or Passing-Bablok regression analysis were calculated.Bias at a minimum of two MDLs was also calculated.ResultsMeasurement procedure comparison statistics for the epoc,RAPIDPoint 500e, and RAPIDLab 348EX blood gas systems (y)versus the RAPIDLab 1265 blood gas system (x) are summarizedin Table 3. Scatter plots for each measurand with the identity line(y x) are depicted in Figures 6 through 14.Further whole blood testing on two additional epoc BloodAnalysis Systems was performed at the Siemens Healthineersfacility in Ottawa, Canada, for the BUN and creatininemeasurands. One Atellica CH 930 Analyzer, located at theSiemens Healthineers Glasgow, Delaware, facility, was used forthe plasma testing. The measurands tested on each SiemensHealthineers platform are identified in Table 2.Table 2. Measurand by platform for comparisons.MeasurandpHpCO2pO2Na K Ca2 ClGluLacCreaBUNRL348EX RP500e epoc RL1265 RL348EX RP500e epocvs RL1265vs Atellica CH e design of the study indicated a minimum of 40 samples,excluding outliers, and preferably 100 samples to be analyzedin duplicate for each measurand. Fresh whole blood wascollected in lithium heparin tubes on each day of the study.Over the course of 16 days, samples were assayed across twoof each blood gas analyzer — the RAPIDPoint 500e, RAPIDLab1265, RAPIDLab 348EX, and epoc systems — in normal syringemode. The first replicate of each sample was tested on Bench#1 on each blood gas system in random order; the secondreplicate of each sample was tested on Bench #2 on each bloodgas system, also in random order. The samples were thencentrifuged, and the resulting plasma removed and stored in atemperature control device at -20 C. The frozen plasma sampleswere subsequently thawed and tested on one Atellica CH 930chemistry system. With three exceptions, only the first replicatewas used for the analysis of the data. In the event that the resultsusing the first replicate tested did not meet the study goal, the58Respiratory Therapy Vol. 16 No. 1 Winter 2021n

Table 3. Summary statistics for the epoc, RAPIDPoint 500e, and RAPIDLab 348EX Blood Gas Systems vs the RAPIDLab 1265 Blood Gas System.ComparisonMeasurandepoc Blood Analysis System vs RAPIDLab1265 Blood Gas SystemRAPIDPoint 500e Blood Gas System vsRAPIDLab 1265 Blood Gas SystemRAPIDLab 348EX Blood Gas System vsRAPIDLab 1265 Blood Gas �3.40.999PassingBablokNa (mmol/L)1311.05–6.20.947PassingBablokK (mmol/L)1141.02–0.150.991WeightedDemingCa2 241.00–2.50.998PassingBablokNa (mmol/L)1310.955.90.986WeightedDemingK (mmol/L)1170.960.200.994WeightedDemingCa2 141.02–2.41.000WeightedDemingNa (mmol/L)1230.968.10.994WeightedDemingK (mmol/L)1050.990.140.992WeightedDemingCa2 .02.30.110.080.020.05–1–2Measurement procedure comparison statistics for theaforementioned blood gas systems (y) versus the commonmeasurands on the Atellica CH 930 chemistry analyzer (x) areRespiratory Therapy Vol. 16 No. 1 Winter 2021nnsummarized in Table 4. Scatter plots for each measurand withthe identity line (y x) are depicted in Figures 15 through 21.59