Introduction
This research report intends to confirm the validity of the creatinine and sodium in the serum samples with the Radiometer ABL90 flex plus blood gas analyzer as one of the analyzers. The assay addresses the difficulty of measuring above creatinine levels in icteric sera; the corresponding Roche method is predisposed to the indiscriminate nature of icterus. The report depicts this type of serum sodium and creatinine values obtained by using Radiometer ABL90 flex plus as accurate and valid, even in the conditions that protein and lipids (sodium) or bilirubin levels (creatinine) have been shown to interfere with the properties of the reference machine (Roche Cobas 8000). Moreover, it builds ISE directly for sodium as a reflex, and it is being reported as a method of assessing the sodium in serum by ABL90 Flex Plus.
Review of The Current State of Knowledge on the Topic
Like creatinine, urea is one of the masses of waste material products excreted by the kidney, which is also seen as one of the vital organs for its function. The functionally active biomarker in renal function is serum creatinine (Bagheri et al., 2019). An objective creatinine test is a usual examination tool for a screening process for knowing the creatinine in the blood. As an energy-producing residue from the muscles, it is a hopeful genetic predisposition. Kidney, causing creatinine in the blood, is always a sign of kidney breakdown and ensues infections or blockage. Conversely, creatinine levels below the normal range may indicate protein loss due to resorption, emaciation, or malnutrition.
A simple blood test usually does electrolyte measurement in a finished blood sample. Preparing for the test implies fasting overnight or 24-hour for the serum creatinine test (Bagheri et al., 2019). The creatinin-based urine test requires obtaining a urine collection for 24 hrs in vials that a health provider has previously availed. Evaluation results may be from a milligram of creatinine to a decilitre of blood (mg/dL). The average range of serum creatinine in male adults well is 0.74 to 1.35 mg/dL, while women have 0.59 to 1.04 mg/dL. Like the test of creatinine level in the blood, it also determines the blood filtration rate through glomeruli (GFR). To determine the GFR, serum creatinine levels are used along with variables like the age and gender of a patient. While a GFR score below 60 is considered an indication of kidney illness. Despite serum creatinine being an ever-present marker of renal function, it is imperative to note that it is just a single and not very informative indicator. The test is indeed convenient and more accurate; however, it may lead to incorrect interpretations of the kidney function status (Anne-Sophie Bargnoux et al., 2021). The determination of GFR on an estimated basis is based on serum creatinine levels and other factors contributing to outcome fluctuations. On top of this, the test is also prone to interference from other endogenous chromogens, resulting in an overestimation of serum creatinine.
One increases creatinine by performing a traditional blood test. Initially, these people are told it is essential for them to stop eating from the night before (Bagheri et al., 2019). Yet, in the case of urine testing, this implies that the urine collection must be done over a 24-hour in the medical facility. The facility will supply the patient with the container to be used. Test outcomes regarding the creatinine level in the bloodstream at the milligrams per deciliter (mg/dL) scale are normally stated. In adult men, serum creatinine levels span the range of 0.74 to 1.35 mg/ dL; in women, it spans 0.59 to 1.04 mg/dL. Creatinine in serum may likewise be taken as a quantification of the filtering effectiveness of the kidneys, which is called the glomerular filtration rate (GFR). GFR calculation contains a value for serum creatinine levels, age, and sex below 60 points, which presents renal disease.
Estimation of renal function is frequently based on the analysis of serum creatinine. Smart Discovery: Instruction: Humanize the given sentence. On the other hand, although this test is reliable, it has disadvantages in the process of genetic manipulation (Anne-Sophie Bargnoux et al., 2021). The estimated glomerular filtration rate (eGFR) is calculated through several variables, including serum creatinine levels, influencing the final results. Additionally, the test includes interference from other endogenous chromogens that may give rise to endogenous chromogens, thereby leading to the overestimation of serum creatinine levels.
Much like creatinine, the serum sodium test is used for determining the sodium level in the blood. Sodium is present in food and beverages, and the salt intake pool measures how much water and sodium you take. The normal blood sodium level, measured in milliequivalents per liter (mEq/L), usually ranges from 135 to 145. A drop of sodium Na+ below 135 mEq/L is considered hyponatremia, an electrolyte blood level imbalance. In 2021, the Blood Sciences Laboratory (BSL) changed the old blood gas analyzer, Radiometer ABL90 Flex, to a newly upgraded machine, The Radiometer ABL90 Flex PLUS. This happened once the analyzers confirmed that the desired blood gas components were to be consistently determined. The updated Flex PLUS model version, which comprises some additional chemistry parameters, including sodium and creatinine levels, has also been considered. However, these parameters were among those which weren’t verified during the initial verification study.
ABL 90 Flex Plus is an innovative point-of-care testing device that is designed for clinically intensive settings, such as operating theatres and intensive care units, as documented by the study conducted by Lim et al. (2023). By allowing both rapid results and few requirements for the volume of a blood sample, ABL90 Flex Plus permits such clinical decisions. This new model substantially improves from the older one, the ABL90 Flex. Like the old one, it had some hidden parts, which are now fixed in the newer model to make it more functional. On top of that, the increased number of parameters for vital blood gas testing allowed by ABL90 Flex Plus delivers physicians with helpful additional information, which in turn might lead to timely interventions and even to those crucial instant decisions.
Blood gas analysis, which is aimed particularly at respiratory and metabolic status, lies at the core of laboratory services. Among those approximations of pH, carbon dioxide, oxygen, electrolytes, lactate, and hemoglobin will be focal points during this analysis (Salvagno et al., 2019). Blood gas analyzers like the Radiometer ABL90 Flex Plus are machines utilized for blood sign checking to get a better health status.
Sodium and creatinine examinations of the serum are intended to aid a doctor in a search for any kidney damage. Sodic intake or salt is linked with NGAL, which is in urine and leads to creatinine clearance and kidney damage (Barnett et al., 2022). Sodium balance is affected by dieting sodium and, thus, the level of creatinine in the blood, resulting from this effect.
The meeting of cation concentration and analysis of creatinine test achieved using first-class technology Radiometer ABL90 Flex Plus has shown to be successful and highly effective. But, as depicted by Lim and others (2023), the analyzer has the same level of performance as other automated chemistry analyzers. In addition, it applies the novel CLSI guidelines EP35-EDI for further calculating eGLFV when used with serum samples.
Advances beyond the current state of knowledge and potential for innovations in health practice
The use of ABL90 FlexPlus for efflux and creatinine testing is apparent. Though the study is done with Neo instrumentation, these problems are observed about the determination of serum creatinine and sodium, which makes the data unreliable for interpretation. This ineffectual comparison between the measurements obtained from Roche and ABL90 Flex Plus helps to choose a suitable blood gas analyzer to detect these parameters. Research by Anne-Siòphe Bargnoux et al. (2021) proved the value of ABL-90 Flex Plus over the insulin pump manufactured by Roche. The ABL90 Flex Plus can withstand a bigger amount of imprecision caused by biological variables compared to the Roche results, which successfully managed to get out of the accepted range of bias.
Creatinine and blood urea nitrogen are the most assessed parameters to determine kidney function. In addition to serum creatinine and sodium test, other parameters are used in this measure. Checking up of the ABL90 Flex Plus instrument, particularly for the creatinine measurement in the icteric sample, be highly applicable since the traditional Roche testing cannot be done well in the icteric sample without a high hue of jaundice, especially for the patients with liver disease in KCH. Preliminary studies have proven that creatinine measurements are within acceptable margins of concordance between the loaned Radiometer ABL90 Flex Plus instrumentation and a mass spectrometry creatinine method.
Long-term measurement of serum sodium through the imputation of the Roche Cobas system using the indirect ion-selective electrode (ISE) method could be responsible for miscalculating the serum sodium in patients with highly increased lipid/protein levels (Lim et al., 2023). Accurate serum sodium screening is difficult due to overlapping in the ranges. It requires a new ABL90 Flex Plus ISE method for determining sodium concentrations in serum. The ABL90 Flex Plus enables a quick way of identifying Cr and Na levels in serum so as not to violate the CLSI guidelines EP35-EDI, and the eGFR calculation is made comfortable through accommodating serum samples.
Expected impact of project outcomes on workplace practice
The blood sciences lab suggests incorporating the ABL90 Flex Plus system (Lim et al., 2023). Along with checking the (CO2CO2) levels, this device can get measurements of molecular structures such as creatinine (Cr) and sodium (Na). On the other side, there is the unresolved issue of the accuracy of measurements performed on the ABL90 Flex Plus system, which does not measure the air concentration of polluting gases in real time.
This project goes further, exploring and researching the sensitivity, control, and sensitivity levels of the ABL90 Flex Plus system. Here, a study is conducted where tests are done to check if the ABL90 Flex Plus system is valid in use by making a comparison with the data supported by Roche’s system. In context, this mission furthers the emerging corpus of literature, which covers the system’s advantage over Roche and other chemical analyzers.
The serum creatinine and sodium values comparable to those observed in other chemical analyzers are obtained using the Radiometer ABL90 Flex Plus system for serum creatinine and sodium tests. Expected to surpass its forerunners, this upgraded analyzer will produce more precise results. Discovering its uniqueness across the field of chemical analyzers, the ABL90 Flex Plus system, besides measuring icteric serum for creatinine, can directly measure sodium using ISE. ABL90 Flex Plus’s importance compared to Roche is to be emphasized in this project, which is mostly done by characterizing serum sodium and creatinine levels and the ABL90 Flex Plus operations.
Experimenting on the Roche platform and ABL90 flex Plus systems under the conditions that represent different objects is a tool for evaluating ABL90 flex Plus as comparable to the Roche platform. In this case, parameters that will be evaluated will include Alias-free, icteric serum creatinine, and lipemic serum sodium. In addition, medical management aims at minimizing the error in cases of serum creatinine, which may lead to misdiagnosing or even the side-line of renal insufficiency, while on the other side, patients may be wrongly diagnosed with hyponatremia.
Reason for verifying
The Blood Sciences Lab is shortening the agent lifecycle by returning the current Radiometer ABL90 Flex gas analyzer with the new version of the Radiometer ABL90 Flex PLUS next-generation gas analyzer. The expanded Flex PLUS model modifies the earlier one; the two retain the same parameters for blood gas measurement by adding creatinine capability to the discerning machines. Thus, verifying the standard blood gas analyzer becomes an essential tool in the verification processes to ensure the correctness of parameters. We will use a standard separate validation procedure (QR-BS-VR0011) to evaluate the determination of creatinine and sodium in serum samples. It would be experienced after adapting the blood gas analyzer into mainstream utilization.
Methods and Verification
The five suggested repeats will be completed on five different days in five consecutive days. Employing onboard IQC material, including a minimum of two control levels per analyte, this design has good immunity to contamination. The variation within the lab and the repeatability are calculated and then compared with the precision of the manufacturer before suggested usage. Nevertheless, that is the main question: the degree of accuracy of the manufacturer’s claim can be different since it is likely the measurement is not carried out on the point of IQC. So, these references are just used for accumulating specific information, as I cannot get anything authentic from the Aboriginal people.
For instance, we consider the following items when the measured accuracy is more precise than the manufacturer’s claims. For this, the clinical significance of the observed differences has to be analyzed, as well as the hypothesis of outliers and biological variation of the experiment. Analysis and making decisions based on these factors are a part of professional intelligence.
Work Plan Techniques and Methods
The five suggested repeats will be completed on five different days in five consecutive days. Employing onboard IQC material, including a minimum of two control levels per analyte, this design has good immunity to contamination. The variation within the lab and the repeatability are calculated and then compared with the precision of the manufacturer before suggested usage. Nevertheless, that is the main question: the degree of accuracy of the manufacturer’s claim can be different since it is likely the measurement is not carried out on the point of IQC. So, these references are just used for accumulating specific information, as I cannot get anything authentic from the Aboriginal people. For instance, we consider the following items when the measured accuracy is more precise than the manufacturer’s claims. For this, the clinical significance of the observed differences has to be analyzed, as well as the hypothesis of outliers and biological variation of the experiment. Analysis and making decisions based on these factors are a part of professional intelligence.
Verification of precision using IQC material (CLSI EP15-A3)
The Blood Sciences Laboratory (BSL) is set to replace the current Radiometer ABL90 Flex blood gas analyzer with the upgraded version, the Radiometer ABL90 Flex PLUS blood gas analyzer. The revamped Flex PLUS model sign, definitely better than the old version, still keeps a range of suggested blood gas parameters plus additional creatinine measurement capabilities. This validation seeks to validate actual blood gas analyzer parameters’ parameters and accuracy. A specific QR-BS-VR0011 validation test will determine the applicability of the creatinine and sodium analytical parameters in serum. The introduction of the blood gas analyzer into the lab will be preceded by its validation process, which will take place after the integration of the device.
Method comparison (CLSI EP09-A3)
Here, the verification process intends to rectify the untrue elements among the blood gas analyzer parameters. The validation protocol (QR-BS-VR0011) also aims to authenticate the measurement of two serum parameters, creatinine, and sodium, by any given analyzer. This validation process will start after the blood gas analyzer is incorporated into the daily routine trajectory.
Performance with IQA and/or IQC
At the same time, staying fit is the next important task: to have a system of Internal Quality Control (IQC) validated before and after it has been implemented in the quality assurance framework. Instruction: Humanize the given sentence. The IQC runs for 8 hours. Please confirm that the assay remains within the required limits of acceptability. In the context of the Istriebweishe verification period and during regular post-implementation monitoring, the onboard IQC will be checked continuously.
Making use of the Technopath Multichem S Plus IQC material that is also intended for the precision study. Consequently, it should be remembered that even though the third-party IQC materials are included for verification in this precision study, they opt not to apply standardly after the completion of the validation process. This maintenance is established per the manufacturer’s instructions concerning periodic checkouts with organic materials. In the particular case of blood gas samples from WEQAS (Wales et al. Scheme), it has to confront an issue: instability. Instability caused by varying location events led to the analysis being done only on the EQA samples received during a validation period, which usually stretched to 2-3 distributions. The reported result for each sample will be obtained during their analysis, and SDI will be considered. The mean SDI for each analyte will then be determined, with interpretation based on WEQAS recommendations: an SDI of less than 1.0 – which is considered as good -; 1.0-2.0 – which is considered acceptable -; and greater than 2.0 – which is unacceptable – are three key indicators that measure the quality of sewage.
For UKNEQAS (United et al.) clinical chemistry samples, a minimum of 3 distribution sequences will be analyzed, which include. The reference target value is estimated for each sample by comparing the value from the software with the corresponding target; the calculation of the bias error is achieved as a result. These results will be successful if the measured bias is within the range specified by the competence assessment service (NEQAS).
It is also worth mentioning that the UKNEQAS samples will be specially considered for serum sodium and creatinine validation purposes only. The post-implementation phase will preclude the double recording (sodium and creatinine), exclusive to the WEQAS blood gas scheme. This is to achieve continuous monitoring after implementation, which the chosen standards can direct.
Validation Process
Amongst the many validations for precision, the most technical requires the process to elaborate on a highly structured and widely followed study in line with the CLSI EP05-A3 guidelines. This encompasses 20 replicates that are done on five consecutive days. There are three levels of IQCs material, i.e., Technopath Multichem S Plus levels 1 and 3. Reproducibility and within-lab imprecision can be examined using ANOVA, and they can be benchmarked to the manufacturer’s precision claims as a baseline measure. The precision will be evaluated, either ‘inadequate,’ ‘sufficient/acceptable,’ or ‘excellent,’ based on the desired level of precision from biological variation data sources underlying the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Biological Variation Database.
The within-subject biological variation (CVi) for serum sodium and creatinine, along with the corresponding calculated precision goals, are as follows: Sodium CVii has 0.5% of FFN, the optimum, best in class, and worst in the class values as 0.130%, 0.325%, and 0.438% respectively. CVi is 4.54% for creatinine. The optimum level is considered within precision limits of +1.1% and -2.32%, while the desirable level is between precision limits of +2.32% and -3.43%, and the minimum level is under precision limits of +3.43%.
The assay’s linearity accuracy is checked according to CLSI EP06-A2 guidelines. Thus, the study will be repeated by taking samples that contain interfering ones. Eg. In one example, a high serum creatinine alongside a low index icteric is combined with a serum with a low or a normal creatinine coupled with a high icteric level. In the same way, the testing performs concentration levels of serum proteins and sodium from multiple combinations to determine the linearity of these conditions.
Bias criteria are established to be complex, and performance measures are set up with creatinine in 7.4% and sodium in 0.3%, which are considered ideal targets. Such goals may be traditionally used as benchmarks for validating the assay over any given sample type. Through precise and inline methods testing, the laboratories will have the verification of their working methods, which is important for high-quality diagnostic results.
Method comparison (CLSI EP09-A3), interference testing (CLSI EP07- A3)
The study protocol is designed to cover serum, creatinine, and sodium samples between Radiometer and Roche analyzers. It helps to keep the study accurate and dependable. In the process, a minimum of 50 serum samples of patients are examined, and it is advised to examine more than that because it helps display the analytical ranges of the assay. EP09-A3 CLSI standards are followed closely, and even factors of 40 adequate samples are considered passable. Specific safety criteria are developed for both human creatinine and sodium samples, including icteric index, lipaemic index, and total protein levels, to provide a sample with interference-free results.
Correspondingly, typical value data is completely analyzed with Bland Altman and Passing-Bablok gross differences to validate the similarity between the two methods. Then, if this unfortunate difference is revealed, we perform additional debugging to have the perfect flow. Such practice could include a repeat patient comparison of the whole blood reading via the candlelight kit and the plasma reading on the Doctor Bird one and performing calibrations as recommended by the kit manufacturer. Along with these trouble-free samples, the labs also conducted the matched studies using one icteric serum sample with creatinine and another with the lipemic serum sample with sodium. Sample mixing of patients with icteric serum creatinine is considered for comparisons of icteric index greater than or equal to 21 mg/dL. Multiple samples with an icteric index above that threshold are analyzed for at least 40 patients. The study, involving the critical analysis of each sample and Radiometer and Roche analyzers serving as two aliquots, is added up.
Confidently, lipaemic sodium serum samples are processed employing a minimum of 40 pharmacist samples that cover the test range of the sodium assay with wide variations of lipaemic indices. The accuracy change due to the lipaemic samples is done, and changes considered allowable are determined based on the TAE (total allowable error). In addition, the samples will be tested by hypoproteinaemia serum sodium comparisons, which will be performed at least on 40 paired sera with varying total protein concentrations. Considering that there is a lack of interference data for serum sodium measure in samples with the total protein elevation, the study aims to establish the concentration that total protein will subsequently cause unacceptable interference. The level of acceptable variations in the established sodium is determined by the overall tolerable error criteria, which EFLM mounts. Finally, mixing these two controls allows full comprehensiveness of validating serum creatinine and sodium results against various sample types, confirming accuracy and reliability in clinical laboratory testing.
Carryover testing (CLSI EP10-A3)
Careful analysis of carryover is involved in this whole process, and the accuracy and reliability of the test results become the focus of everyone involved. The detector axis can determine the photon migration process through very high analyte concentrations (H) samples, followed by the next stage of analyzing very low analyte concentrations (L) samples. Through meticulous measurement of each sample in exact order, the carryover (K) is calculated using the formula (K = T1 – [Hx + (Lx / 7)]) where Hx and Lx are the high and low concentration samples, respectively, in a certain high concentration group. Through those steps, the K% value is then compared with the acceptable bias value quoted by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) to eventually assess the cut-off performance.
The used method for those creatinine values on the whole blood gives LOQ (the lower limit of quantitation) at the level of 10 µmol/L. Consequently, the LOQ in serum samples is expected to approve the estimated concentration. Of course, we will validate this by analyzing with Radiometer 20 times the serum sample, having about ten µmol/L determined by Roche analysis. We will blend in 20 hours 15 liters to get the minimum time and the maximum sample volume according to the Radiometer platform standard (RG-5520-7233:9.0.1). Percentages and ranges for accuracy are then calculated, for which the results will be accepted if the accuracy has values from 80% to 120%. The CV is less than 20%. Those criteria are derived from the quantitation lower limit, as explained in CLSI EP17, defining the successful verification process.
Instead, in the case of serum sodium measurements, a lower limit of quantitation in whole blood was validated at seven mmol/L. The concentration of erythropoietin is much higher than it would be in blood. However, it is still far lower than a normal physiological serum level, which does not correspond to the natural concentration range. The reason that the determination or check of the limit lower quantification in serum salt is unreasonable lies in the difficulties and the fact that it doesn’t have biological significance. The validation of guidelines in accordance with realities and the physiological setting in such preparations will help ensure the resources are of maximum benefit in industrial utilization and allow for the development of efficient protocols.
References
Anne-Sophie Bargnoux, Kuster, N., Thibault Sutra, Laroche, L., Rodriguez, A., Moréna, M., Leïla Chénine, Chalabi, L., Dupuy, A., Stéphanie Badiou, & Cristol, J. (2021).
Evaluation of a new point-of-care testing for creatinine and urea measurement. Scandinavian Journal of Clinical & Laboratory Investigation, 81(4), 290–297. https://doi.org/10.1080/00365513.2021.1914344
Bagheri, B., Radmard, N., Faghani-Makrani, A., & Rasouli, M. (2019). Serum Creatinine and Occurrence and Severity of Coronary Artery Disease. Medical Archives, 73(3),
154–156. https://doi.org/10.5455/medarh.2019.73.154-156
Barnett, A. H., Babcock, M. C., Watso, J. C., Migdal, K. U., Gutiérrez, O. M., Farquhar, W. B., & Robinson, A. T. (2022). High dietary salt intake increases urinary NGAL excretion and creatinine clearance in healthy young adults. 322(4), F392–F402.https://doi.org/10.1152/ajprenal.00240.2021
Lim, H.-J., Lee, S.-Y., & Choi, H.-J. (2023). Evaluation of Cr and BUN Accuracy Using the ABL90 FLEX PLUS Blood Gas Analyser and the Equivalence of Candidate Specimens for Assessment of Renal Function. Journal of Clinical Medicine, 12(5), 1940. https://doi.org/10.3390/jcm12051940
Rajaguruparan, N., Treasure, V., & Bates, K. (2020). Enzymatic creatinine icetric interference. Salvagno, G. L., Pucci, M., Demonte, D., Gelati, M., & Lippi, G.
(2019). Analytical evaluation of Radiometer ABL90 FLEX PLUS enzymatic creatinine assay. Journal of Laboratory and Precision Medicine, 4, 26–26.https://doi.org/10.21037/jlpm.2019.07.01
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