NIST Reference Materials: Utility and Future

Choquette, Steven J.; Duewer, David L.; Sharpless, Katherine E.

doi:10.1146/annurev-anchem-061318-115314

Cited by 10 publications

(8 citation statements)

References 39 publications

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“…For method calibration, a spike sample (e.g., spiking a certified OTA calibration standard into a corn blank) could be used to calibrate the method, but only if the spike sample is fully characterized and the commutability of the calibration standard in corn is established (JCGM, 2012; Choquette et al., 2020; Vesper et al., 2007). This task would be challenging if no matrix CRMs, such as SRM 1565, existed or were accessible.…”

Section: Discussionmentioning

confidence: 99%

“…For this reason, the availability of a matrix CRM such as SRM 1565 is appreciated (Beauchamp et al., 2021). NIST matrix SRMs are developed using reference measurement processes with higher metrological orders (Choquette et al., 2020). With limited availability, extending the available mycotoxin matrix reference materials to other food matrices seems to be a practical approach, but it also could be challenging, as food matrices vary (e.g., corn to corn‐based feed vs. corn to tree nuts), leading to biased results of target mycotoxins.…”

Section: Discussionmentioning

confidence: 99%

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Ochratoxin A case study: Establish metrological traceability of mycotoxin measurements using certified reference materials

Zhang,

Tran,

Phillips

2023

Journal of Food Science

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For the US Food and Drug Administration's (FDA) mycotoxin program, the desired application of certified reference materials (CRMs) is primarily for validating methods for the determination of mycotoxins in foods and establishing metrological traceability of measurement results generated by such validated methods. The latter has been an important but insufficiently addressed challenge due to the lack of appropriate protocols and CRMs. Taking advantage of two recently available mycotoxin CRMs, OTAN‐1 and Standard Reference Material (SRM) 1565, a protocol was developed for systematically examining uncertainty and establishing metrological traceability of measurement results of ochratoxin A (OTA) in corn through a series of calibration operations using the two CRMs. Instrument and method calibrations were performed using OTAN‐1 and SRM 1565. The OTA value and its standard and expanded (k = 2, approximately 95% confidence) uncertainties were estimated from the calibration data and documented. These results demonstrate that the major contributing source of uncertainty is the sample matrix, highlighting the important role of the certified matrix reference material in method calibration. The value of OTA (38.5 ± 7.2 µg/g; 95% confidence interval) in the incurred sample was metrologically traceable to the International System of Units through two CRMs using the multi‐laboratory validated liquid chromatography–mass spectrometry FDA compendial method. In addition, an alternative estimation of uncertainty was conducted using a one‐point calibration, resulting in comparable uncertainty.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Ochratoxin A case study: Establish metrological traceability of mycotoxin measurements using certified reference materials

Zhang,

Tran,

Phillips

2023

Journal of Food Science

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“…The National Institute of Standards and Technology (NIST) provides reference materials (RM) for promoting accuracy and metrological traceability of chemical measurements and validation of chemical measurement processes. 19 NIST RM 8671, a humanized IgG with an Nglycosite in the Fc domain, is widely used as an mAb model for methods evaluation. There have been numerous efforts in interpreting the N-glycan structures of RM 8671.…”

Section: Introductionmentioning

confidence: 99%

“…Therefore, new methods for accurate and sensitive analysis of mAb N-glycosylation should be developed. The National Institute of Standards and Technology (NIST) provides reference materials (RM) for promoting accuracy and metrological traceability of chemical measurements and validation of chemical measurement processes . NIST RM 8671, a humanized IgG with an N- glycosite in the Fc domain, is widely used as an mAb model for methods evaluation.…”

Section: Introductionmentioning

confidence: 99%

Structure-Specific N-Glycoproteomics Characterization of NIST Monoclonal Antibody Reference Material 8671

Bai

Tian

2022

J. Proteome Res.

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The characteristics of monoclonal antibodies (mAbs) cohering various function effectors show great expectation in therapy. Glycosylation, one of the common post-translational modifications, deeply influences cohesion. It is necessary to grasp monosaccharide composition/sequence and glycan structures in mAbs. There has been comprehensive mass spectrometry characterization of N-glycosylation of mAbs, and monosaccharide compositions are deduced according to known biosynthetic rules. Our recently developed intact N-glycopeptide search engine GPSeeker has made structure-specific characterization of Nglycosylation possible with structure-diagnostic fragment ions from selective fragmentation of N-glycan moieties. Here, we report our structure-specific N-glycoproteomics characterization of NIST monoclonal antibody reference material 8671 using GPSeeker, and 59 N-glycan structures (including 16 pairs of isomers) are characterized.

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“…Multiomics reference materials and relevant QC metrics are required for quality assessment of each omics measurement and its horizontal integration before successful multiomics-level vertical data integration [45][46][47][48] . Unrelated reference materials have been widely used as "ground truth" for performance evaluation of technologies for the same omics type, such as the genomic DNA 49,50 , tumor-normal paired DNA [51][52][53] , RNA, protein, or metabolite reference materials [54][55][56][57] .…”

mentioning

confidence: 99%

Ratio-based quantitative multiomics profiling using universal reference materials empowers data integration

Zheng

Liu

Yang

et al. 2022

Preprint

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Multiomics profiling is a powerful tool to characterize the same samples with complementary features orchestrating the genome, epigenome, transcriptome, proteome, and metabolome. However, the lack of ground truth hampers the objective assessment of and subsequent choice from a plethora of measurement and computational methods aiming to integrate diverse and often enigmatically incomparable omics datasets. Here we establish and characterize the first suites of publicly available multiomics reference materials of matched DNA, RNA, proteins, and metabolites derived from immortalized cell lines from a family quartet of parents and monozygotic twin daughters, providing built-in truth defined by family relationship and the central dogma. We demonstrate that the "ratio"-based omics profiling data, i.e., by scaling the absolute feature values of a study sample relative to those of a concurrently measured universal reference sample, were inherently much more reproducible and comparable across batches, labs, platforms, and omics types, thus empower the horizontal (within-omics) and vertical (cross-omics) data integration in multiomics studies. Our study identifies "absolute" feature quantitation as the root cause of irreproducibility in multiomics measurement and data integration, and urges a paradigm shift from "absolute" to "ratio"-based multiomics profiling with universal reference materials.

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NIST Reference Materials: Utility and Future

Cited by 10 publications

References 39 publications

Ochratoxin A case study: Establish metrological traceability of mycotoxin measurements using certified reference materials

Ochratoxin A case study: Establish metrological traceability of mycotoxin measurements using certified reference materials

Structure-Specific N-Glycoproteomics Characterization of NIST Monoclonal Antibody Reference Material 8671

Ratio-based quantitative multiomics profiling using universal reference materials empowers data integration

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