False negative results in the Roche assay for                HDL-cholesterol

Bakker, A.; Zijlstra, Appie; Leemhuis, M.P.

doi:10.1258/000456303322326533

Cited by 10 publications

(3 citation statements)

References 16 publications

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“…Variation of results of Cobas 6000 was found to be not signi cant. This nding seemed to be a bit perplexing because a brief review of existing literature pointed to the problem speci cally against the Roche HDL-C reagent used in Cobas 6000 (16,(18)(19)(20). However, on a detailed enquiry with the OEM, it was noted that the HDL-C kit in use during 2003-04, when the articles were published, were of 2nd generation.…”

Section: Discussionmentioning

confidence: 99%

Paraprotein interferences: Insights from a short study involving multiple platforms and multiple measurands.

Sarkar

2023

Preprint

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Background: Though paraproteinaemic interferences is a well-known phenomenon in clinical chemistry, a large-scale evaluation study involving multiple paraproteinaemic specimens on multiple platforms including multiple measurands with an aim to provide a predictive analysis, is singularly lacking. The present study aims to fill this gap in research. Material & Methods: This cross-sectional non-interventional observational study involved thirteen paraproteinaemic subjects, determined their gamma globulin characterization and measured their total bilirubin, direct bilirubin, HDL-cholesterol, calcium, inorganic phosphate, iron and unsaturated iron binding capacity (UIBC) levels on a dry chemistry platform (Vitros 350) as the established method and two wet chemistry platforms (AU5800 and Cobas 6000) as the evaluation methods. Data thus generated was analyzed for any significant variation and tested if such variation increased with decreasing albumin/ globulin ratio. Results: Significant variation between dry chemistry and wet chemistry measurements were obtained for direct bilirubin, HDL and iron on AU5800 with p-values of 0.0009, <0.0001 and 0.0466 respectively. Similarly, discrepant results were obtained on Cobas 6000 for direct bilirubin and iron, with p-values of <0.0001 and 0.0002 respectively. Additionally, UIBC measurements on AU5800 varied significantly with increasing amounts of paraprotein present in the specimen (p-value = 0.0207). Conclusion: This study emphasizes on predictive analyses to show that paraprotein interferences are fairly common on wet chemistry platforms. Evolving algorithms for monitoring of reaction curves can minimize release of erroneous results due to such interferences.

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Section: Discussionmentioning

confidence: 99%

Paraprotein interferences: Insights from a short study involving multiple platforms and multiple measurands.

Sarkar

2023

Preprint

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“…[5][6][7][8] In one study by Za pi co et al fo ur HIV in fec ted pa ti ents with poly clo nal hyper gam mag lo bu li ne mia had fal sely low HDL-C re sults. 9 Li ke wi se, our auto im mu ne he pa ti tis ca se had a poly clo nal hyper gam mag lo bu li ne mi a with un de tec tab le HDL-C levels.…”

Section: Discussionmentioning

confidence: 99%

False Negative High Density Lipoprotein- Cholesterol in an Autoimmune Hepatitis Patient: Case Report

Barutçuoğlu¹,

Basol²,

Bozdemir³

et al. 2010

Turkiye Klinikleri J Med Sci

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A AB BS S T TR RA AC CT T False-negative high density lipoprotein-cholesterol (HDL-C) detection is a remarkable condition in clinical laboratory practice. We report an 18-year-old female who admitted to transplantation division, with cirrhotic process of autoimmune hepatitis in which polyclonal hypergammaglobulinemia negatively interfered with HDL-C. The HDL-C and immunoglobulin G (IgG) levels were measured before and after liver transplantation. The patient had high IgG with polyclonal hypergammaglobulinemia and an undetectable HDL-C before transplantation. Falsely undetectable HDL-C levels were ruled out by two easy methods: sample dilution and back calculation based on Friedewald formula. This false negative value of HDL-C was also confirmed with lipoprotein electrophoresis. One must be careful in hyperimmunglobulinemic patients when using direct homogeneous HDL-C assay.K Ke ey y W Wo or rd ds s: : Hepatitis, autoimmune; cholesterol, HDL; hypergammaglobulinemia Ö ÖZ ZE ET T Yanlış negatif yüksek yoğunluklu lipoprotein-kolesterol (HDL-K) saptanması klinik laboratuvar uygulamalarında dikkat edilmesi gereken bir durumdur. Bu olgu sunumunda, otoimmun hepatitten siroza ilerlemiş 18 yaşında bayan hastada, poliklonal hipergammaglobulineminin HDL-K üzerine olan negatif interferansı gösterilmektedir. HDL-K ve immunglobulin G (IgG) karaciğer transplantasyonu öncesi ve sonrası ölçüldü. Transplantasyon öncesi olgunun yüksek IgG'yle birlikte poliklonal hipergammaglobulinemisi ve yanlış negatif HDL-K'ü bulunmaktadır. Poliklonal hipergammaglobulinemi varlığında, HDL-K'ün negatif olmadığı, iki kolay yöntem ile dışlanmıştır: örnek dilusyonu ve Friedewald formülü kullanılarak HDL-K'ün tersten hesaplanması. Ayrıca lipoprotein elektroforezi ile yanlış negatif HDL-K değeri doğrulanmıştır. Hiperimmunoglobulinemik hastalarda direkt homojen HDL-K ölçümünde dikkatli olunmalıdır. u to im mu ne he pa ti tis is a chro nic nec ro inf lam ma tory li ver di se a se cha rac te ri zed by mas si ve in fil tra ti on of lymphocy tes and plas mocytes in the por tal tract and se ro lo gi cally high ti ters of an ti-smo oth musc le an ti body (AS MA), an ti-ds DNA an ti body, cytop las mic-an ti ne utrop hil cytop las mic an ti bo di es (C-AN CA), an ti nuc le ar an ti body (ANA) or an ti mi toc hon dri al an ti body (AMA), and high glo bu lin le vels. 1 The li ver plays a ma jor ro le in the re gu la ti on of fatty acid, trigl yce ri de, and cho les terol me ta bo lisms. Se ve re li ver in jury as in cirr ho sis, of ten le ads to a dec re a -

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“…Besides a few systematic studies—such as paraprotein interference with the measurement of total and direct bilirubin and high density lipoprotein cholesterol (HDL-C) on two automated chemistry analyzers using 88 samples with paraproteins [1] , and the study of interference with a direct bilirubin assay using 117 samples containing paraproteins [2] —the majority of these reports described specific cases of either IgM, IgG, or IgA paraprotein interference with various laboratory tests. There have been several reports of IgM paraprotein interference with albumin [3] , glucose [4] , [5] , C-reactive protein [6] , uric acid [7] , HDL-C [8] , [9] , [10] , total bilirubin [8] , [11] , phosphate [5] , creatinine [12] , [13] , [14] , [15] , calcium [16] , and total protein [17] , [18] , [19] . Interestingly, each of these cases described individual IgM paraprotein interferences with a particular assay on a particular platform.…”

Section: Introductionmentioning

confidence: 99%

The pH of chemistry assays plays an important role in monoclonal immunoglobulin interferences

Alberti

Drake

Song

2015

Practical Laboratory Medicine

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ObjectivesImmunoglobulin paraproteins can interfere with multiple chemistry assays. We want to investigate the mechanisms of immunoglobulin interference.Design and methodsSerum samples containing paraproteins from the index patient and eight additional patients were used to investigate the interference with the creatinine and total protein assays on the Beckman Coulter AU5400/2700 analyzer, and to determine the effects of pH and ionic strength on the precipitation of different immunoglobulins in these patient samples.ResultsThe paraprotein interference with the creatinine and total protein assays was caused by the precipitation of IgM paraprotein in the index patient's samples under alkaline assay conditions. At extremely high pH (12–13) and extremely low pH (1–2) and low ionic strength, paraprotein formed large aggregates in samples from the index patient but not from other patients.ConclusionsThe pH and ionic strength are the key factors that contribute to protein aggregation and precipitation which interfere with the creatinine and total protein measurements on AU5400/2700. The different amino acid sequence of each monoclonal paraprotein will determine the pH and ionic strength at which the paraprotein will precipitate.

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False negative results in the Roche assay for HDL-cholesterol

Cited by 10 publications

References 16 publications

Paraprotein interferences: Insights from a short study involving multiple platforms and multiple measurands.

Paraprotein interferences: Insights from a short study involving multiple platforms and multiple measurands.

False Negative High Density Lipoprotein- Cholesterol in an Autoimmune Hepatitis Patient: Case Report

The pH of chemistry assays plays an important role in monoclonal immunoglobulin interferences

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