Folate and vitamin B12 assays after recalibration to the WHO International Standard 03/178: making the interpretation as simple as possible, but not simpler

Ferraro, Simona; Panteghini, Mauro

doi:10.1515/cclm-2019-0050

Cited by 8 publications

(8 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Furthermore, evaluating the inter-assay variability of B12 measurement at serum concentrations around the established thresholds for the risk of deficiency may be useful in indicating if the established cut-offs may be used or require an adjustment according to the employed method. 11 According to guidelines 12 and knowing that some substances as biotin could interfere with the assays, both CHORUS VIT B12 and CHORUS FOLATE were tested in presence of interfering components which, however, did not alter the clinical significance of results. A comparison study of vitamin B12 assay included Roche COBAS and indicated an agreement between Roche COBAS and other immunoassay autoanalyzers, specifically DxI 800 Unicel (Beckman Coulter, USA), ADVIA Centaur XP (Siemens Diagnostics, Tarrytown, NY, USA), Architect i2000sr (Abbott Laboratories, Abbott Park, IL, USA).…”

Section: Discussionmentioning

confidence: 99%

“…Consequently, the prevalence of folate deficiency is strictly dependent on the correctness of cut-off establishment and the accuracy of folate assays. 11 This paper describes the validation, performances, and reliability of two automated tests for vitamin B12 and folate quantification. A comparison with a commercially available kit was also provided.…”

Section: Introductionmentioning

confidence: 99%

“…Consequently, the prevalence of folate deficiency is strictly dependent on the correctness of cut-off establishment and the accuracy of folate assays. 11…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Validation, performance, and reliability of two automated tests for vitamin B12 and folate assay

Bianciardi,

Tesi,

Cerutti

et al. 2023

Journal of Public Health Research

View full text Add to dashboard Cite

Background: Deficiency of Vitamin B12 and folate may determine hematological, neurological, and metabolic alterations; therefore, an accurate quantification of their serum levels is required, especially in the presence of symptoms that might suggest a deficiency. CHORUS VIT B12 and CHORUS FOLATE are two automated immunoassays, developed to quantify vitamin B12 and folate, respectively, in human serum. Design and methods: This single-center, non-pharmacological, diagnostic study described the validation and characterization of CHORUS VIT B12 and CHORUS FOLATE, with a specific focus on performance, precision, and reliability. For each assay, 500 serum samples were analyzed. A comparison between CHORUS assays and commercially available kit was also performed. Results: For CHORUS VIT B12 the lower limit of quantification (LLoQ) was 165.0 pg/mL and the upper LoQ (ULoQ) was 1846.8 pg/mL. The assay was linear within the calibration range (150–2000 pg/mL) and the accuracy was described with the International Standard Vitamin B12, Serum Folate, HOLO TC (NIBSC code: 03/178), with a mean recovery on two lots of 111%. For CHORUS FOLATE (calibration range of 2.0–20.0 ng/mL), LLoQ was 2.0 ng/mL and ULoQ 19.6 ng/mL. The linearity was demonstrated from 2.4 to 20.0 ng/mL; the accuracy was described with the International Standard mentioned above, achieving a mean recovery on three lots of 92%. The lowest and highest values of both CHORUS and COBAS kits were similar and the median values did not significantly vary. Conclusion: CHORUS VIT B12 and CHORUS FOLATE performed well, accurately, and reliably in quantifying vitamin B12 and folate in human serum.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Validation, performance, and reliability of two automated tests for vitamin B12 and folate assay

Bianciardi,

Tesi,

Cerutti

et al. 2023

Journal of Public Health Research

View full text Add to dashboard Cite

show abstract

“…To comply with the requirements of the EU Directive, the majority of manufacturers of tFOL MSs currently calibrate their internal calibrators to the WHO IS 03/178 [12]. We conducted this study to establish if the use of this material as a higher-order has actually improved the between-assay harmonization, allowing the intermethod variability to decrease to a level suitable for clinical application of tFOL measurements.…”

Section: Discussionmentioning

confidence: 99%

“…This RMP has been used to assign tFOL target values to the WHO International Standard (IS) 03/178, established in 2005 [10]. Therefore, a complete RMS for serum tFOL assays is in place and, at present, to comply with the requirements of the European Union (EU) In Vitro Diagnostics Directive [11], the majority of manufacturers trace their measuring systems (MSs) to it by calibrating their internal calibrators to the WHO IS 03/178 reference material [12]. However, data are still lacking for definitively establishing if the use of the IS 03/178 as the common calibrator of commercial MSs has actually improved the between-assay harmonization, allowing the intermethod bias to decrease to a level suitable for clinical application of folate measurements [13].…”

Section: Introductionmentioning

confidence: 99%

Trueness evaluation and verification of inter-assay agreement of serum folate measuring systems

Braga

Frusciante²,

Ferraro³

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

Self Cite

View full text Add to dashboard Cite

BackgroundDefinitive data to establish if the use of the WHO International Standard (IS) 03/178 as a common calibrator of commercial measuring systems (MSs) has improved the harmonization of serum total folate (tFOL) measurements to a clinically suitable level are lacking. Here, we report the results of an intercomparison study aimed to verify if the current inter-assay variability is acceptable for clinical application of tFOL testing.MethodsAfter confirming their commutability, the IS 03/178 and National Institute for Standards and Technology SRM 3949 L1 were used for evaluating the correctness of traceability implementation by manufacturers and the MSs trueness, respectively. The inter-assay agreement was verified using 20 patient pools. The measurement uncertainty (U) of tFOL measurements on clinical samples was also estimated. An outcome-based model for defining desirable performance specifications for bias and imprecision for serum tFOL measurements was applied.ResultsThe majority of evaluated MSs overestimated the WHO IS value of +5% or more with the risk to produce an unacceptably high number of false-negative results in clinical practice. The mean inter-assay CV on all pools and on those with tFOL values >3.0 μg/L (n = 15) was 12.5% and 7.1%, respectively. In neither case the goal of 3.0% was fulfilled. The residual bias resulted in an excessive U of tFOL measurement on clinical samples.ConclusionsThe implementation of traceability of tFOL MSs to the WHO IS 03/178 is currently inadequate, resulting in an inter-assay variability that does not permit the use of a common threshold for detecting folate deficiency.

show abstract

Association of maternal folate and B12 vitamin status with gestational diabetes mellitus: Still an open issue

Chibireva

Szõke

Borille

et al. 2023

Clinica Chimica Acta

View full text Add to dashboard Cite

Folate and vitamin B12 assays after recalibration to the WHO International Standard 03/178: making the interpretation as simple as possible, but not simpler

Cited by 8 publications

References 9 publications

Validation, performance, and reliability of two automated tests for vitamin B12 and folate assay

Validation, performance, and reliability of two automated tests for vitamin B12 and folate assay

Trueness evaluation and verification of inter-assay agreement of serum folate measuring systems

Association of maternal folate and B12 vitamin status with gestational diabetes mellitus: Still an open issue

Contact Info

Product

Resources

About