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

Hedeland, Ylva; Gustafsson, Christina M.; Touza, Zinah; Ridefelt, Peter

doi:10.1111/ijlh.13188

Cited by 11 publications

(8 citation statements)

References 32 publications

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“…The data in this study have demonstrated a good correlation in results between normal and spiked haemolysed plasma samples in PT, APTT, Clauss fibrinogen and TT with the observed overall difference between the means for two samples within 5% for all four tests. Data for PT obtained in this study which compared normal and spiked haemolysed lyophilized plasma appeared to be in line with previous findings which used spiked fresh or frozen plasma where PT was insignificantly influenced by haemolysis 17‐20 . A statistical difference between the means of two samples was noted in ACL TOP user group which used IL HemosIL RecombiPlasTin 2G method.…”

Section: Discussionsupporting

confidence: 90%

“…Comparable data received for the overall means for two samples in Clauss fibrinogen testing suggest that haemolysis does not have potential to cause major changes on test result. Previous comparison studies with the use of genuine haemolysed or spiked fresh plasmas reported analogous results for fibrinogen 3,20,21 . The tendency for higher per cent difference which was also statistically significant between two samples was obvious within the Sysmex platform group which used Siemens Thrombin reagent.…”

Section: Discussionmentioning

confidence: 61%

“…Activated partial thromboplastin time testing data have shown 1.1% difference between the overall means of the two samples for the individual reagent kits and analysing platforms used for APTT testing. Similar comparison studies where spiked fresh or frozen plasma was used demonstrated a range of results for APTT testing where a general trend was difficult to determine, suggesting that APTT result in haemolysed sample is highly dependent on the reagent and testing platform used 17‐21 . The effects of in vitro haemolysis that has occurred during sample collection and processing on APTT are highly variable, with false prolongation and false shortening of APTT indicating that the effects are multifactorial so spiking may have particular limitations when assessing APTTs 3 …”

Section: Discussionmentioning

confidence: 95%

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Pre‐analytical variables in haemostasis: Findings from the United Kingdom National External Quality Assessment scheme for Blood Coagulation (UK NEQAS BC) haemolysis exercise

Brown¹,

Jennings²,

Kitchen³

et al. 2021

Int J Lab Hematology

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Introduction Haemolysis is considered one of the major contributors of nonconformities and sample rejection in coagulation testing. Materials and methods Two lyophilized plasmas were distributed to 800 centres registered for prothrombin time (PT), activated partial thromboplastin time (APTT) and either Clauss fibrinogen or thrombin time (TT) in the UK NEQAS BC programme. The same pool of normal plasma was used to prepare both samples, to one of which red blood cell haemolysate was added to mimic haemolysis at 3 g/L haemoglobin concentration. Participants were asked to complete a questionnaire about their laboratory approach to dealing with haemolysed samples, including strategies used to deal with different levels of haemolysis. Results Results for tests performed did not show great differences between the two samples. It should be noted that artificially constructed haemolysed samples may not behave in the same way as patient samples (ie, may not be commutable). However, the possibility of carrying out a large multicentre study for detection of haemolysis was demonstrated. Inconsistency in practice was observed with 226/551 (41%) of centres indicated they reject haemolysed samples solely on visual checks, and 163 (30%) using initial visual checks with further sample rejection evaluation by analyser flags. Furthermore, 333 (72%) of centres indicated that the level of haemolysis affects sample rejection decisions, while 132 (28%) stated it did not. Conclusion Variability of responses for dealing with haemolysed samples reflects a lack of clear consistency in the pre‐analytical area of sample processing.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 61%

Section: Discussionmentioning

confidence: 95%

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Pre‐analytical variables in haemostasis: Findings from the United Kingdom National External Quality Assessment scheme for Blood Coagulation (UK NEQAS BC) haemolysis exercise

Brown¹,

Jennings²,

Kitchen³

et al. 2021

Int J Lab Hematology

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“…The effect of hemolysis was most pronounced on the DRVVT Screen and DRVVT Ratio, with the potential to cause a false‐negative lupus anticoagulant test result by this methodology when the H index approached or exceeded 500 mg/dL. The effect of hemolysis on the other assays evaluated was considered minimal (≤15% bias) up to a plasma hemoglobin concentration of 900 mg/dL, which is similar to other reports, 11,12 although a progressive shortening of the PT and APTT was observed with both the optical and mechanical platforms, likely reflecting a biological effect of hemolysis on clot activation. Several methods have been proposed for studying the effects of hemolysis on coagulation assays, including paired hemolyzed and nonhemolyzed samples collected at different times from the same patient and in vitro spiking studies using hemolysate prepared by freeze‐thaw, osmotic shock, or shearing with multiple needle aspirations, each method having its own limitations 13,14 .…”

Section: Discussionsupporting

confidence: 82%

Revisiting the effects of spectral interfering substances in optical end‐point coagulation assays

Seheult

Dalenberg

Sridharan

et al. 2021

Int J Lab Hematology

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Introduction Hemolysis, icterus, and lipemia (HIL) are common pre‐analytical variables in the clinical laboratory. Understanding their effects on coagulation laboratory results is essential. Methods HIL effects on the prothrombin time (PT), activated partial thromboplastin time (APTT), dilute Russell's viper venom time (DRVVT), thrombin time (TT), and protein C chromogenic activity (CFx) were evaluated on the ACL TOP 750 optical analyzer and STA‐R Evolution mechanical analyzer (PT and APTT only) by spiking normal donor, patient, and commercial control samples with varying concentrations of hemolysate, bilirubin, or a lipid emulsion. The relative difference or bias compared to the original results was determined. Results Hemolysis (H) indices up to 900 mg/dL did not affect the APTT, PT, DRVVT Confirm, TT, and CFx; however, H indices above approximately 200 mg/dL resulted in a false‐negative DRVVT screen and screen/confirm ratio in samples with a lupus anticoagulant. There was an artifactual prolongation of the PT and APTT when conjugated bilirubin was dissolved in aqueous solvents and not when it was dissolved in dimethyl sulfoxide. Icterus (I) indices up to 45 mg/dL did not result in significant (>15%) bias for all assays evaluated. The PT and APTT assays failed to produce a robust clot curve when the lipemia (L) index exceeded 6000 milliabsorbance units (mAbs), and the TT and DRVVT assays failed when the L index exceeded 3000 mAbs; the CFx assay was unaffected by lipemia. Conclusions Verification of the manufacturer's recommended interference thresholds is important since it may avoid inappropriate instrument flagging and/ or sample rejection.

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“…In this study, no significant impact of hemolysis was found up to hemoglobin concentrations of 10 g/L, which was higher compared with the manufacturers’ data (Table 2) and previous studies on other assays. For instance, a recent study performed with the STA‐Liatest D‐Di Plus reagent on a STAR MAX 2 analyzer found that D‐dimer values started to increase from 6 g/L of hemoglobin 26 27 who found no significant change in D‐dimer concentrations up to 300 mg/L of bilirubin.…”

Section: Discussionmentioning

confidence: 99%

Analytical performance of a new immunoturbidimetric D‐dimer assay and comparison with available assays

Talon

Fourneyron

Trapani

et al. 2022

Research and Practice in Thrombosis and Haemostasis

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Background The routine D‐dimer quantification to exclude venous thromboembolism has led to the development of many assays, the usefulness of which depends on their reliability and performance. Objective We evaluated the analytical performances of the immunoturbidimetric Yumizen G DDi 2 assay (HORIBA Medical, Montpellier, France) performed on the Yumizen G800 analyzer and compared it with other available D‐dimer assays. Methods Within‐run and between‐run imprecision were evaluated using low‐ and high‐level quality‐control plasma samples. Interference due to hemolysis, icterus, lipemia, rheumatoid factor (RF), or heterophilic antibodies (human antimouse antibodies [HAMAs]) was evaluated by spiking plasma samples with hemolysate, bilirubin, Intralipid, RF, or HAMAs. The measurements obtained with the different D‐dimer assays were compared using Passing‐Bablok regression analysis and Bland‐Altman plot method, using fresh citrated plasma samples collected from 66 consecutive routine patients with a wide range of D‐dimer concentrations. Results Within‐ and between‐run variation coefficients for the Yumizen G DDi 2 assay ranged from 1.7% to 5.8% and from 2.8% to 5.5%, respectively. Hemolysis and icterus did not have any effect up to 10 g/L hemoglobin and 300 mg/L bilirubin. Lipemia seemed to generate an underestimation of D‐dimer concentration when the Intralipid concentration was >5 g/L. RF and HAMAs did not have any effect. The Passing‐Bablok and Bland‐Altman analyses showed small differences with other available D‐dimer assays, which were more pronounced with increasing values. Conclusions Its analytical performances and main technical features indicate that the new Yumizen G DDi 2 assay is suitable for the rapid quantification of D‐dimer in clinical hemostasis laboratories.

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

Cited by 11 publications

References 32 publications

Pre‐analytical variables in haemostasis: Findings from the United Kingdom National External Quality Assessment scheme for Blood Coagulation (UK NEQAS BC) haemolysis exercise

Pre‐analytical variables in haemostasis: Findings from the United Kingdom National External Quality Assessment scheme for Blood Coagulation (UK NEQAS BC) haemolysis exercise

Revisiting the effects of spectral interfering substances in optical end‐point coagulation assays

Analytical performance of a new immunoturbidimetric D‐dimer assay and comparison with available assays

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