Hemolysis indexes for biochemical tests and immunoassays on Roche analyzers: Determination of allowable interference limits according to different calculation methods

Monneret, Denis; Mestari, Fouzi; Atlan, Gregory; Corlouer, Camille; Ramani, Zo; Jaffré, Jérémy; Dever, Sylvie; Fressart, Véronique; Alkouri, Rana; Lamari, Foudil; Devilliers, C.; Imbert‐Bismut, Françoise; Bonnefont‐Rousselot, Dominique

doi:10.3109/00365513.2014.993691

Cited by 41 publications

(31 citation statements)

References 17 publications

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“…In our study, though the hemolysis interference on biochemistry analytes was dependent on the analyzer system, the interference on CK, AST, LDH, and K was consistent with former studies using the Cobas 6000 c501 analyzer or Roche analyzers . This confirmed that a common mechanism underlies the observed hemolysis interference.…”

Section: Discussionsupporting

confidence: 92%

“…Hemolysis index (HI) generated by analyzers is an effective tool to counteract the hemolysis challenge, as it can standardize the process of identifying hemolytic specimens and estimate the hemolysis interferences quantitatively . Even though it was reported that the hemolysis index (HI) was accurate and highly reproducible among different platforms and laboratories, determining the HI threshold is the key to identify hemolytic effects.…”

Section: Introductionmentioning

confidence: 99%

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Determination of hemolysis index thresholds for biochemical tests on Siemens Advia 2400 chemistry analyzer

Liu

Zhang

et al. 2019

Clinical Laboratory Analysis

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BackgroundIn vitro hemolysis is still the most common source of pre‐analytical nonconformities. This study aimed to investigate the hemolytic effects on commonly used biochemical tests as well as to determine the hemolysis index (HI) thresholds on Siemens Advia 2400 chemistry analyzer.MethodsPeripheral blood samples were collected from forty healthy volunteers. Hemolysis was achieved using syringes. Five hemolysis levels were produced including the no hemolysis group, slight hemolysis group, mild hemolysis group, moderate hemolysis group, and heavy hemolysis group. We then used the bias from baseline (no hemolysis) and HI to construct regression functions. The HI corresponding to the bias limits was considered as HI thresholds. We chose the total allowable error (TAE) as the bias limit.ResultsOf the twenty‐eight analytes, ten analytes had clinical significance. Creatine kinase‐MB, creatine kinase, potassium, aspartate aminotransferase, and hydroxybutyrate dehydrogenase were all positively affected; the corresponding HI threshold was 45.2, 99.96, 4.07, 10.16, and 7.94, respectively. Lactate dehydrogenase was also positively interfered, but we failed to calculate the HI threshold. Total bile acid, uric acid, and sodium were all negatively affected, and the HI threshold was 42.23, 500 and 501.8, respectively. Glucose was also negatively interfered, but it failed to achieve the HI threshold.ConclusionsWhen the HI value was higher than its threshold, the corresponding analyte was considered inappropriate for reporting. The implementation of the assay‐specific HI thresholds could provide an accurate method to identify analytes interfered by hemolysis, which would improve clinical interpretations and further boost laboratory quality by reducing errors associated with hemolysis.

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Section: Discussionsupporting

confidence: 92%

Section: Introductionmentioning

confidence: 99%

Determination of hemolysis index thresholds for biochemical tests on Siemens Advia 2400 chemistry analyzer

Liu

Zhang

et al. 2019

Clinical Laboratory Analysis

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“…change limit [ACL] [3,26]), as well as the arbitrary 10% cut-off point commonly used by manufacturers and laboratories [8,27,28]. Analytical test results from hemolyzed samples have also previously been reported heterogeneously.…”

Section: Discussionmentioning

confidence: 99%

Handling of hemolyzed serum samples in clinical chemistry laboratories: the Nordic hemolysis project

Gidske¹,

Aakre

Rustad³

et al. 2019

Clinical Chemistry and Laboratory Medicine (CCLM)

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Background Some clinical chemistry measurement methods are vulnerable to interference if hemolyzed serum samples are used. The aims of this study were: (1) to obtain updated information about how hemolysis affects clinical chemistry test results on different instrument platforms used in Nordic laboratories, and (2) to obtain data on how test results from hemolyzed samples are reported in Nordic laboratories. Methods Four identical samples containing different degrees of hemolysis were prepared and distributed to 145 laboratories in the Nordic countries. The laboratories were asked to measure the concentration of cell-free hemoglobin (Hb), together with 15 clinical chemistry analytes. In addition, the laboratories completed a questionnaire about how hemolyzed samples are handled and reported. Results Automated detection of hemolysis in all routine patient samples was used by 63% of laboratories, and 88% had written procedures on how to handle hemolyzed samples. The different instrument platforms measured comparable mean Hb concentrations in the four samples. For most analytes, hemolysis caused a homogenous degree of interference regardless of the instrument platform used, except for alkaline phosphatase (ALP), bilirubin (total) and creatine kinase (CK). The recommended cut-off points for rejection of a result varied substantially between the manufacturers. The laboratories differed in how they reported test results, even when they used the same type of instrument. Conclusions Most of the analytes were homogeneously affected by hemolysis, regardless of the instrument used. There is large variation, however, between the laboratories on how they report test results from hemolyzed samples, even when they use the same type of instrument.

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“…Approximately 3.5% of blood samples arriving for biochemical testing present with haemolysis [31,32], which represents a source of interference with analyte determination. To compensate for this, haemolysis indexes (HI) have been established, but allowable limits of haemoglobin are not uniform, which introduces variability into analyte determination [33]. Clearly, it is important to improve coagulability and at the same time minimise haemolysis, which we have been able to do using OsPA addition to blood collection tubes.…”

Section: Discussionmentioning

confidence: 99%

Next-generation rapid serum tube technology using prothrombin activator coagulant: fast, high-quality serum from normal samples

Zhao

Dimeski

Jersey

et al. 2018

Clinical Chemistry and Laboratory Medicine (CCLM)

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BackgroundIncomplete blood clotting or latent clotting in serum is a common laboratory problem, especially for patients on anticoagulant therapy or when serum tubes are centrifuged before clotting is completed. We describe a novel approach to producing high-quality serum using snake venom prothrombin activator complex (OsPA) as an additive in blood collection tubes for non-anticoagulated (normal) individuals.MethodsPlasma clotting assays were performed using a Hyland-Clotek instrument. Blood clotting was visually observed, and thromboelastography was also performed to determine the important parameters of coagulation. Thrombin generation was assayed using the chromogenic substrate S-2238, and biochemical analytes in the serum were determined on chemistry and immunoassay analysers. Fibrinogen was determined by either ELISA or Clauss fibrinogen assay.ResultsWe initially showed that OsPA had strong coagulation activity in clotting not only recalcified citrated plasma and recalcified citrated whole blood, but also fresh whole blood in a clinical setting. The use of TEG clearly showed improved speed of clotting and generation of a firmer clot. We also showed that the use of OsPA to produce serum did not interfere with the determination of commonly measured biochemical analytes. The underlying clotting mechanism involves a burst of thrombin production at the initial stages of the clotting process upon contact with prothrombin in blood.ConclusionsThese results demonstrate rapid generation of high-quality serum, contributing to faster turnaround times with standardised quality samples, for accurate analyte determinations in normal individuals.

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Hemolysis indexes for biochemical tests and immunoassays on Roche analyzers: Determination of allowable interference limits according to different calculation methods

Abstract: This study proposes new HI based on different allowable limits, and can therefore serve as a starting point for future harmonization of hemolysis interference evaluation needed in routine laboratory practice.

Cited by 41 publications

References 17 publications

Determination of hemolysis index thresholds for biochemical tests on Siemens Advia 2400 chemistry analyzer

Determination of hemolysis index thresholds for biochemical tests on Siemens Advia 2400 chemistry analyzer

Handling of hemolyzed serum samples in clinical chemistry laboratories: the Nordic hemolysis project

Next-generation rapid serum tube technology using prothrombin activator coagulant: fast, high-quality serum from normal samples

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