Commutability of Reference Materials for α-Fetoprotein in Human Serum

Yue, Yuhong; Zhang, Shunli; Xu, Zhenzhen; Chen, Xi; Wang, Qingtao

doi:10.5858/arpa.2016-0441-oa

Cited by 8 publications

(8 citation statements)

References 11 publications

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“…In this study, we also described a method of harmonization using non-commutable EQA materials, which is important for EQA organization. Although we could not demonstrate the commutability of human serum pools (commutable EQA), some studies have provided evidence regarding the commutability of these materials through the same preparation technique [ 12 , 14 , 19 , 20 ].…”

Section: Discussionmentioning

confidence: 72%

“…After excluding outliers on the basis of three standard deviations, the median values of the NCCL EQA materials were used to determine the systematic biases. The commutability of the EQA materials was carried out following Clinical and Laboratory Standards Institute (CLSI) guideline EP30-A and difference in bias based on the recommendations by the IFCC Working Group on Commutability [12][13][14][15] and commutability-related biases were determined on the basis of backcalculation among assays after correcting for systematic biases via Deming regression.…”

Section: Discussionmentioning

confidence: 99%

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Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data

et al. 2021

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Background This study aimed to assess the comparability among assays using freshly frozen human sera and external quality assessment (EQA) data in China. Methods Twenty-nine serum samples and two commercial EQA materials, obtained from the National Center for Clinical Laboratories (NCCL), were analyzed in triplicate using eight routine TSH assays. The commutability of commercial EQA materials (NCCL materials) was evaluated in accordance with the CLSI EP30-A and IFCC bias analysis. Median values obtained for the NCCL EQA materials were used to determine the systematic and commutability-related biases among immunoassays through back-calculation. The comparability of TSH measurements from a panel of clinical samples and NCCL EQA data was determined on the basis of Passing–Bablok regression. Furthermore, human serum pools were used to perform commutable EQA. Results NCCL EQA materials displayed commutability among three or five of seven assay combinations according CLSI or IFCC approach, respectively. The mean of systematic bias ranged from -13.78% to 9.85% for the eight routine TSH assays. After correcting for systematic bias, averaged commutability-related biases ranged between -42.26% and 12.19%. After correction for systematic and commutability -related biases, the slopes indicating interassay relatedness ranged from 0.801 to 1.299 using individual human sera, from 0.735 to 1.254 using NCCL EQA data, and from 0.729 to 1.115 using pooled human serum EQA(the commutable EQA). Conclusions The harmonization of TSH measurement is challenging; hence, systematic and commutability-related biases should be determined and corrected for accurate comparisons among assays when using human individual serum and the commercial EQA materials.

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Section: Discussionmentioning

confidence: 72%

Section: Discussionmentioning

confidence: 99%

Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data

et al. 2021

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“…The relationship between μg and IU usually is given as 1.21 μg = 1000 IU, but conversion factors may widely vary by assay and this may represent a significant source of inter-assay variability and bias. Furthermore, the commutability of WHO 72/225 preparation has been questioned [47] and some authors have observed that running immunoassays still suffer from significant inter-method variability limiting the comparability of AFP results [48].…”

Section: The Importance Of the Afp Assaymentioning

confidence: 99%

Serum α-fetoprotein in pediatric oncology: not a children’s tale

Ferraro

Panzeri

Braga

et al. 2018

Clinical Chemistry and Laboratory Medicine (CCLM)

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Background Measurement of α-fetoprotein (AFP) concentrations in the serum of infants is useful for the management of testicular germ cell tumors, hepatoblastoma and hepatocellular carcinoma. Here, we provide a critical review of the available information about pediatric reference intervals (RI), focusing on their utility in interpreting AFP as an aid for cancer diagnosis. Content Evidence sources in the available literature were critically appraised. Out of 3873 retrieved papers, 24 were finally selected and carefully inspected, and six of them overcame exclusion criteria (i.e. methodological limitations in the study design, statistical gaps, drawbacks in traceability of the AFP assay to higher order materials and/or biased reporting of AFP results). Preterm and term infants up to the 3rd month of life exhibited the highest average AFP concentrations, but the attempt of defining RI by data pooling and partitioning for age intervals was impeded by the wide variability of data. The inability of defining robust RI in the first months of life made difficult, if not impossible, using upper reference limits for ruling out malignancies with a single AFP result. Evaluating the behavior of AFP concentrations 5 days from the baseline result, if this exceeds risk thresholds partitioned for age, according to the formula Xt=X0*2−t/HL (where: t=days elapsed for AFP retest; HL=AFP half-life according to age; X0=AFP baseline concentration, and Xt=predicted AFP concentration at day 5), could give a better information. Summary Novel studies defining AFP RI in infants based on robust methodology are warranted to improve the interpretation of AFP results in pediatric oncology. In the meantime, algorithms based on both serum AFP absolute concentrations and HL may aid in cancer diagnosis.

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“…As with other protein biomarkers, in large centralized facilities, the methods of choice for AFP detection are immunoassays performed in automated instruments [7]. To reduce the ever-increasing health expenditures and decentralize the analysis, the extreme success of glucometer for diabetes patients, an electrochemical biosensor, is a model to imitate.…”

Section: Introductionmentioning

confidence: 99%

On the Electrochemical Detection of Alpha-Fetoprotein Using Aptamers: DNA Isothermal Amplification Strategies to Improve the Performance of Weak Aptamers

et al. 2020

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Affinity characterization is essential to develop reliable aptamers for tumor biomarker detection. For alpha-fetoprotein (AFP), a biomarker of hepatocellular carcinoma (HCC), two DNA aptamers were described with very different affinity. In this work, we estimate the dissociation constant of both of them by means of a direct assay on magnetic beads modified with AFP and electrochemical detection on carbon screen-printed electrodes (SPCE). Unlike previous works, both aptamers showed similar dissociation constant (Kd) values, in the subµM range. In order to improve the performance of these aptamers, we proposed the isothermal amplification of the aptamers by both terminal deoxynucleotidyl transferase (TdT) and rolling circle amplification (RCA). Both DNA amplifications improved the sensitivity and also the apparent binding constants from 713 nM to 189 nM for the short aptamer and from 526 nM to 32 nM for the long aptamer. This improvement depends on the true affinity of the binding pair, which ultimately limits the analytical usefulness.

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Commutability of Reference Materials for α-Fetoprotein in Human Serum

Cited by 8 publications

References 11 publications

Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data

Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data

Serum α-fetoprotein in pediatric oncology: not a children’s tale

On the Electrochemical Detection of Alpha-Fetoprotein Using Aptamers: DNA Isothermal Amplification Strategies to Improve the Performance of Weak Aptamers

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