Analytic validation of commercially available immunoassays for the measurement of serum cobalamin and folate concentrations in pigs

Grützner, Niels; Knabe, D. A.; Lawhorn, Bruce; Dominguez, Brandon; Kauffold, Johannes; Suchodolski, Jan S.; Steiner, Jörg M.

doi:10.1111/vcp.12361

Cited by 3 publications

(9 citation statements)

References 30 publications

(42 reference statements)

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“…These results were not only within recommended ranges (80-120%, 75-125%) 2,47 but also similar to those reported by others using Immulite immunoassays in pigs (92-123% and 85-115% for cobalamin and folate, respectively) 22 and in cats (96-122% for cobalamin). 43 Compared to published studies using Immulite assays, the Tosoh CVs were similar to those generated for pigs (CVs ≤6.1% and ≤8.7% for cobalamin and folate, respectively) 22 and lower than for cats (cobalamin CV 11.3%). 3 Inter-assay CVs were lower than those generated by the Immulite for pigs (CV ≤9.6% and ≤12.5% for cobalamin and folate, respectively) 22 and cats (cobalamin CV 15.2%).…”

Section: Discussionsupporting

confidence: 90%

“…Compared to published studies using Immulite assays, the Tosoh CVs were similar to those generated for pigs (CVs ≤6.1% and ≤8.7% for cobalamin and folate, respectively) 22 and lower than for cats (cobalamin CV 11.3%). 3 Inter-assay CVs were lower than those generated by the Immulite for pigs (CV ≤9.6% and ≤12.5% for cobalamin and folate, respectively) 22 and cats (cobalamin CV 15.2%).…”

Section: Discussionsupporting

confidence: 70%

“…12,22,29 Very high coefficients of determination ( r 2 > 0.99) were generated for both analytes in serially diluted samples, with cobalamin and folate recoveries of 95–106% and 96–102%, respectively. These results were not only within recommended ranges (80–120%, 75–125%) 2,47 but also similar to those reported by others using Immulite immunoassays in pigs (92–123% and 85–115% for cobalamin and folate, respectively) 22 and in cats (96–122% for cobalamin). 43…”

Section: Discussionmentioning

confidence: 99%

“…30,39 However, in veterinary medicine, analytical validation studies of cobalamin and folate assays are not only sparse 5,22,43 but all available publications utilize the same human chemiluminescence immunoassays (Immulite, Siemens Healthineers, Erlangen, Germany). 3,8,22,43 Although the publication of more in-depth validation studies on the chemiluminescence immunoassays would be welcome, these assays have been widely accepted as having satisfactory linearity, recovery, and precision. Published studies tend to corroborate precision data provided by the manufacturer [cobalamin CVs intra-assay: 13%, 7%, and 6.7%; inter-assay: 15%, 6%, and 7.9%; folate CVs intra-assay: 6.9%, 4.1%, and 2.4%; inter-assay: 8.8%, 5.7%, and 5.2%; each for low-, medium-, and high-quality control material (QCM), respectively].…”

Section: Introductionmentioning

confidence: 99%

“…6 In the human field, several commercial immunoassays are available for the measurement of cobalamin and folate; validation and method comparison studies have demonstrated these assays to have acceptable levels of precision, with good-to-moderate correlation but poor agreement between different methods. 30,39 However, in veterinary medicine, analytical validation studies of cobalamin and folate assays are not only sparse 5,22,43 but all available publications utilize the same human chemiluminescence immunoassays (Immulite, Siemens Healthineers, Erlangen, Germany). 3,8,22,43 Although the publication of more in-depth validation studies on the chemiluminescence immunoassays would be welcome, these assays have been widely accepted as having satisfactory linearity, recovery, and precision.…”

Section: Introductionmentioning

confidence: 99%

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Analytical quality assessment and method comparison of immunoassays for the measurement of serum cobalamin and folate in dogs and cats

2019

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Serum cobalamin and folate are often measured in cats and dogs as part of laboratory testing for intestinal disease, small intestinal dysbiosis, or exocrine pancreatic deficiency. We performed an analytical validation of human immunoassays for cobalamin and folate measurement (AIA-900 analyzer, Tosoh Bioscience) and compared results with those obtained using chemiluminescence assays (Immulite 2000 analyzer, Siemens Medical Solutions Diagnostics). Accuracy, precision, total observable error (TEobs%), and σ values were calculated for the immunoassays. Correlation and agreement were evaluated with Deming regression, Passing–Bablok regression, and Bland–Altman analysis. Cobalamin intra-assay and inter-assay CVs were 1.8–9.3% and 2.6–6.8%, respectively. Folate intra-assay and inter-assay CVs were 1.5–9.1% and 3.4–8.1%, respectively. TEobs (%) were ≤19 and ≤31 for cobalamin and folate, respectively. Sigma values were 3.60–11.50 for cobalamin and 2.90–7.50 for folate. Regression analysis demonstrated very high or high correlations for cobalamin [ r = 0.98 (dogs), 0.97 (cats)] and folate [ r = 0.88 (dogs), 0.92 (cats)] but Bland–Altman analysis revealed poor agreement for both. The immunoassays had good analytical performance for measuring cobalamin and folate in both species. Results obtained by the 2 analyzers cannot be used interchangeably and should be interpreted using instrument-specific reference intervals. Further studies are required to establish immunoassay-specific reference intervals and to evaluate the diagnostic performance and clinical utility of the analyzer for these analytes.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 70%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Analytical quality assessment and method comparison of immunoassays for the measurement of serum cobalamin and folate in dogs and cats

2019

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Assessment of folate and cobalamin concentrations in relation to their dependent intracellular metabolites in serum of pigs between 6 and 26 weeks of age

Grützner

Opriessnig

Lopes

et al. 2020

Research in Veterinary Science

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Efficacy and tolerance of oral versus parenteral cyanocobalamin supplement in hypocobalaminaemic dogs with chronic enteropathy: a controlled randomised open‐label trial

Dor,

Nixon,

Salavati Schmitz

et al. 2024

J of Small Animal Practice

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ObjectivesDetermine comparative tolerance of daily oral and weekly parenteral cobalamin supplementation, in hypocobalaminaemic dogs with chronic enteropathy. Determine whether oral is as effective as parenteral supplementation at achieving eucobalaminaemia, in hypocobalaminaemic dogs with protein‐losing enteropathy, severe hypocobalaminaemia or high canine inflammatory bowel disease activity index at inclusion.Materials and MethodsThirty‐seven client‐owned dogs with hypocobalaminaemia and clinical signs of chronic enteropathy were prospectively enrolled in three UK referral centres. Dogs were randomly allocated to daily oral for 12 weeks or weekly parenteral cobalamin supplementation for 6 weeks and one additional dose 4 weeks later. Serum cobalamin, body condition score, canine inflammatory bowel disease activity index and bodyweight were assessed at inclusion, weeks 7 and 13. Serum methylmalonic acid concentration was evaluated at inclusion and at week 13. Owners completed treatment adherence, palatability, tolerance and satisfaction questionnaires at week 13.ResultsNineteen dogs completed the study. All dogs orally supplemented achieved normal or increased cobalaminaemia at weeks 7 and 13. There was no statistical difference in cobalamin concentration at week 13 in dogs treated with oral or parenteral supplementation, regardless of presence of protein‐losing enteropathy, severity of hypocobalaminaemia or canine inflammatory bowel disease activity index at inclusion. Serum methylmalonic acid concentration was not significantly different between oral and parenteral groups, neither were treatment adherence, satisfaction, and tolerance scores at week 13.Clinical SignificanceOral is as effective and as well‐tolerated as parenteral cobalamin supplementation in hypocobalaminaemic dogs with chronic enteropathy and severe clinical or biochemical phenotypes, and should be considered as a suitable treatment option regardless of disease severity.

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Analytic validation of commercially available immunoassays for the measurement of serum cobalamin and folate concentrations in pigs

Cited by 3 publications

References 30 publications

Analytical quality assessment and method comparison of immunoassays for the measurement of serum cobalamin and folate in dogs and cats

Analytical quality assessment and method comparison of immunoassays for the measurement of serum cobalamin and folate in dogs and cats

Assessment of folate and cobalamin concentrations in relation to their dependent intracellular metabolites in serum of pigs between 6 and 26 weeks of age

Efficacy and tolerance of oral versus parenteral cyanocobalamin supplement in hypocobalaminaemic dogs with chronic enteropathy: a controlled randomised open‐label trial

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