Precision, accuracy, cross reactivity and comparability of serum indices measurement on Abbott Architect c8000, Beckman Coulter AU5800 and Roche Cobas 6000 c501 clinical chemistry analyzers

Gabaj, Nora Nikolac; Miler, Marijana; Vrtarić, Alen; Hemar, Marina; Filipi, Petra; Kocijančić, Marija; Smolčić, Vesna Šupak; Ćelap, Ivana; Šimundić, Ana-Maria

doi:10.1515/cclm-2017-0889

Cited by 41 publications

(14 citation statements)

References 16 publications

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“…The Architect measures hemolysis at 500, 524, 572, 604, 628, 660, and 804 nm and returns a numerical value that approximately corresponds to g/L of free hemoglobin. The Architect hemolysis readings have proved to exhibit acceptable accuracy and reproducibility . Also, the used Architect instrument participates in an external quality program for HIL from EQUALIS AB .…”

Section: Methodsmentioning

confidence: 99%

Hemolysis interference in 10 coagulation assays on an instrument with viscosity‐based, chromogenic, and turbidimetric clot detection

Hedeland

Gustafsson

Touza

et al. 2020

Int J Lab Hematology

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Introduction: Hemolysate in plasma samples from patients may cause misleading results in coagulation assays. Even though modern coagulation instruments often are equipped with modules that can detect hemolysis, icterus, and lipemia (HIL), studies that report the influence of these interferences are still limited. The present paper focuses on the influence of hemolysis on 10 coagulation assays.Methods: Artificial hemolysis was created by freezing/thawing, and the hemolysates generated were added to pools of patient plasma. Pathological and normal levels were pooled separately. These spiked samples were analyzed on a STA R Max 2 instrument. The coagulation assays evaluated utilize clot, chromogenic, or immunoturbidimetric detection. Results:Four of the evaluated assays were not influenced by hemolysis: fibrinogen, von Willebrand factor antigen, activated partial thromboplastin time, and factor VIII.Interestingly, normal and slightly elevated prothrombin time (INR < 2.0) was insensitive to hemolysis, whereas samples with a high INR (≥2.0) exhibited falsely high readings. The assays for antithrombin and fibrin D-dimer displayed an intermediate sensitivity to hemolysis. The most sensitive assay turned out to be anti-Xa, followed by protein C and protein S. For the anti-Xa assay, the results are decreased by 10% already at 0.5 g/L hemoglobin. Conclusion:The present study shows that hemolysis affects several of commonly used coagulation assays. Since the sensitivity for hemolysis is dependent on the brand of the assay as well as the instrument and principle of measurement, it is necessary to evaluate the influence of each specific combination. K E Y W O R D Scoagulation, freezing, hemoglobin interference, hemolysis, pre-analytical error, serum indices

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Section: Methodsmentioning

confidence: 99%

Hemolysis interference in 10 coagulation assays on an instrument with viscosity‐based, chromogenic, and turbidimetric clot detection

Hedeland

Gustafsson

Touza

et al. 2020

Int J Lab Hematology

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“…Generally, the normal hemoglobin concentration in human blood is 130-160 g/L for males and 120-150 g/L for females [30]; thus, the total IgE in completely hemolyzed blood samples of a normal human will be decreased by approximate 20% when analyzed through ECLIA due to interference, according to our results. A series of evaluation methods and indicators reflect the interference on different biomarkers and test methods in the clinical laboratories, such as the hemolytic index (HI), ± 10% change of concentrations from baseline (± 10%Δ) [14,31,32]. However, for postmortem biochemical analyses, more serious interfering factors are observed relative to clinical situations.…”

Section: Discussionmentioning

confidence: 99%

Interference of hemolysis on the postmortem biochemical analysis of IgE by ECLIA

Wang

Jia

et al. 2021

Int J Legal Med

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Forensic diagnosis of anaphylactic shock is a challenging task in forensic practice due to the lack of characteristic morphological changes. Postmortem analysis of serum IgE can provide helpful information for determining anaphylaxis. However, postmortem serum always suffers from hemolysis. To investigate the interference of hemolysis on postmortem analysis of total IgE by electrochemiluminescent immunoassay (ECLIA) and verify the suitability of the commercially available ECLIA kit for postmortem hemolyzed blood with the dilution-correction method, different levels of hemolyzed serum were prepared to evaluate the interference of hemolysis. A linear regression analysis was then performed on the concentration of total IgE in the completely hemolyzed blood and the corresponding serum. Our results indicated that hemolysis negatively interfered with the total IgE analysis by ECLIA and the interference (|Bias%|) increased with increasing levels of hemolysis. After controlling for |Bias%| by dilution, the test concentration of total IgE in the completely hemolyzed blood was still significantly lower than that in the serum (P < 0.05) and resulted in eight false-negative cases. A strong correlation was observed between the test concentration of total IgE in the completely hemolyzed blood and that in the serum (r = 0.983). After correction by the regression formula, the corrected concentration revealed no significant differences and exhibited the same diagnostic ability, compared with the serum total IgE concentration. These results indicate that the completely hemolyzed blood is not recommended for postmortem analysis of total IgE directly. The dilution-correction method might have potential utility in forensic practice for evaluating serum total IgE concentrations.

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“…Samples were processed in Alinity c chemistry analysers (Abbott Laboratories, Illinois, USA and its quantitative results were given in g/L of haemoglobin (H-index), µmol/L of bilirubin (I-index) or of added intralipid (L-index) (SI units), according to manufacturer´s instructions. Alinity c utilizes the same wavelengths as Architect c8000/ c16000 (H-index: 500/524 nm; I-index: 572/604 nm and 628/660 nm; L-index: 524/804 nm) (15). Total bilirubin concentration and HIL indices were externally controlled once time per month using the Biochemistry Serum and Serum Indices Programmes, respectively, provided by The External Quality Control Programme from the Spanish Society of Laboratory Medicine (SEQC-ML).…”

Section: Methodsmentioning

confidence: 99%

Utility of icteric index in clinical laboratories: more than a preanalytical indicator

Mondéjar

Reyes

Madrid

et al. 2021

Biochem. med. (Online)

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Introduction: Total bilirubin tests are highly demanded in clinical laboratories. Since icteric index (I-index) has zero cost, we aimed to evaluate its clinical utility and cost-effectiveness to determine if total bilirubin is necessary to be tested. We took into account if haemolysis could interfere to icteric index determination. Material and methods: Retrospectively we reviewed I-index results in two cohorts (43,372 and 8507 non-haemolysed and haemolysed samples, respectively). All determinations were done using Alinity c chemistry analysers (Abbott Diagnostics). Receiver operating characteristic (ROC) curve was used to determine the optimal index cut-off to discriminate between normal and abnormal bilirubin concentration (20.5 µmol/L). Results: The ROC curve analysis suggested 21.4 µmol/L as the optimal I-index cut-off but differences in sensitivity and specificity were detected between patient derivation. For rejecting purpose, 15.4 µmol/L and 17.1 µmol/L I-index thresholds were selected based on patient derivation (inpatients and emergency room; and primary care and outpatients, respectively) with 97% sensitivity and 0.25% false negative results. Sensitivity was much lower in haemolysed samples. We selected 34.2 µmol/L I-index as threshold to detect hyperbilirubinemia with 99.7% specificity and 0.26% false positive results, independent of haemolysis. With the icteric index cut-offs proposed, we would save 66% of total bilirubin requested and analyse total bilirubin in around 2% of samples without total bilirubin requested. Conclusions: This study supports the use of I-index to avoid bilirubin determination and to identify patients with hyperbilirubinemia. This work considers that the economic and test savings could help to increase the efficiency in clinical laboratories.

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Precision, accuracy, cross reactivity and comparability of serum indices measurement on Abbott Architect c8000, Beckman Coulter AU5800 and Roche Cobas 6000 c501 clinical chemistry analyzers

Abstract: There is heterogeneity between analyzers in the hemolysis, icteria, lipemia (HIL) quality performance. Verification of serum indices in routine work is necessary to establish analytical specifications.

Cited by 41 publications

References 16 publications

Hemolysis interference in 10 coagulation assays on an instrument with viscosity‐based, chromogenic, and turbidimetric clot detection

Hemolysis interference in 10 coagulation assays on an instrument with viscosity‐based, chromogenic, and turbidimetric clot detection

Interference of hemolysis on the postmortem biochemical analysis of IgE by ECLIA

Utility of icteric index in clinical laboratories: more than a preanalytical indicator

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