EXPRESS: A survey of the reactivity of in-vitro diagnostic bilirubin reagents developed in Japan using artificially prepared bilirubin materials: A comparison of synthetic delta, unconjugated, and taurine-conjugated bilirubin

2021 ◽  
pp. 000456322110266
Author(s):  
Sachiko Kiuchi ◽  
Hiroshi Ihara ◽  
Susumu Osawa ◽  
Midori Ishibashi ◽  
Kiyoko Kinpara ◽  
...  
Keyword(s):  
Measurement Procedure ◽  
Reference Measurement ◽  
Bilirubin Oxidase ◽  
Naturally Occurring ◽  
Reference Measurement Procedure ◽  
Vanadic Acid ◽  
In Vitro Diagnostic ◽  
Conjugated Bilirubin

Background: In-vitro diagnostic (IVD) bilirubin reagents based on oxidation with bilirubin oxidase (BOX) or vanadic acid (VA) for total and direct-reacting bilirubin (TB and DB) are widely used in Japan; however, their reactivity to unconjugated and conjugated bilirubin (UCB and CB) and delta bilirubin (DLB) has not been completely disclosed by manufacturers. We used artificially prepared bilirubin materials to investigate the reactivity with four IVD bilirubin reagents. Methods: Porcine UCB solution, chemically synthesized ditaurobilirubin (DTB) solution, and chemically synthesized DLB solution were used as surrogates of naturally occurring UCB, CB, and DLB, respectively. The TB and DB concentrations were measured by three BOX methods and one VA method, and the observed concentrations were compared with those obtained by the diazo-based reference measurement procedure (RMP). Results: The UCB and DLB concentrations were similar when any of the four IVD bilirubin reagents were used during TB measurement. This was consistent with RMP and exhibited a converged inter-method variation. Compared with RMP, significantly low DTB concentrations were observed by the IVD bilirubin reagents despite the converged inter-method variation. In DB measurement, some reagents reacted doubtfully with UCB, while showed lower DTB concentrations than its corresponding TB concentration. Reactivity with DLB was different for each method including RMP. Some reagents were developed to react less with DLB and others to strongly react with DLB. Conclusions: We revealed the reactivity of IVD-TB and IVD-DB reagents to artificially prepared bilirubin materials, and their consistency with RMP. The DB data results vary depending on the reagents used.

scholarly journals Proposed Serum Cholesterol Reference Measurement Procedure by Gas Chromatography–Isotope Dilution Mass Spectrometry

2011 ◽  
Vol 57 (4) ◽  
pp. 614-622 ◽  
Author(s):  
Selvin H Edwards ◽  
Mary M Kimberly ◽  
Susan D Pyatt ◽  
Shelton L Stribling ◽  
Kara D Dobbin ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Gas Chromatography ◽  
Serum Cholesterol ◽  
Isotope Dilution ◽  
Isotope Dilution Mass Spectrometry ◽  
Measurement Procedure ◽  
Standard Reference Materials ◽  
Reference Measurement ◽  
Reference Measurement Procedure ◽  
The Mean

BACKGROUND Our purpose was to establish a mass spectrometry reference measurement procedure (RMP) for cholesterol to use in the CDC's standardization programs. We explored a gas chromatography–isotope dilution mass spectrometry (GC-IDMS) procedure using a multilevel standard calibration curve to quantify samples with varying cholesterol concentrations. METHODS We calibrated the mass spectrometry instrument by isotope dilution with a pure primary standard reference material and an isotopically enriched cholesterol analog as the internal standard (IS). We diluted the serum samples with Tris-HCl buffer (pH 7.4, 0.05 mol/L, 0.25% Triton X-100) before analysis. We used 17 serum pools, 10 native samples, and 2 standard reference materials (SRMs). We compared the GC-IDMS measurements with the CDC's modified Abell–Levy–Brodie–Kendall (AK) RMP measurements and assessed method accuracy by analyzing 2 SRMs. We evaluated the procedure for lack of interference by analyzing serum spiked with a mixture of 7 sterols. RESULTS The mean percent bias between the AK and the GC-IDMS RMP was 1.6% for all samples examined. The mean percent bias from NIST's RMP was 0.5% for the SRMs. The total %CVs for SRM 1951b levels I and II were 0.61 and 0.73%, respectively. We found that none of the sterols investigated interfered with the cholesterol measurement. CONCLUSIONS The low imprecision, linear response, lack of interferences, and acceptable bias vs the NIST primary RMP qualifies this procedure as an RMP for determining serum cholesterol. The CDC will adopt and implement this GC-IDMS procedure for cholesterol standardization.

Verification of Low-Density Lipoprotein Cholesterol Levels Measured by Anion-Exchange High-Performance Liquid Chromatography in Comparison with Beta Quantification Reference Measurement Procedure

2020 ◽  
Author(s):  
Daisuke Manita ◽  
Hiroshi Yoshida ◽  
Isao Koyama ◽  
Masakazu Nakamura ◽  
Yuji Hirowatari
Keyword(s):  
Anion Exchange ◽  
Clinical Laboratory ◽  
Measurement Procedure ◽  
Calculation Methods ◽  
Serum Samples ◽  
Cvd Risk ◽  
Blood Samples ◽  
Reference Measurement ◽  
Reference Measurement Procedure ◽  
Homogeneous Assays

Abstract Background A new lipoprotein testing method based on anion-exchange HPLC (AEX-HPLC) was recently established. We verified the accuracy of LDL-C levels, a primary therapeutic target for the prevention of cardiovascular disease (CVD), measured by AEX-HPLC comparing with LDL-C levels measured by beta quantification-reference measurement procedure (BQ-RMP), homogenous assays, and calculation methods. Methods We compared LDL-C levels measured by AEX-HPLC (adLDL-Ch: LDL-Ch and IDL-Ch) and BQ-RMP using blood samples from 52 volunteers. AdLDL-Ch levels were also compared with those measurements by homogeneous assays and calculation methods (Friedewald equation, Martin equation, and Sampson equation) using blood samples from 411 participants with dyslipidemia and/or type 2 diabetes. Results The precision and accuracy of adLDL-Ch were verified by BQ-RMP. The mean percentage bias [bias (%)] for LDL-C was 1.2%, and the correlation was y = 0.990x + 3.361 (r = 0.990). These results met the acceptable range of accuracy prescribed by the National Cholesterol Education Program. Additionally, adLDL-Ch levels were correlated with LDL-C levels measured by the 2 homogeneous assays (r > 0.967) and the calculation methods (r > 0.939), in serum samples from patients with hypertriglyceridemia. Conclusions AEX-HPLC is a reliable method for measuring LDL-C levels for CVD risk in daily clinical laboratory analyses.

scholarly journals Assessment of Digital PCR as a Primary Reference Measurement Procedure to Support Advances in Precision Medicine

2018 ◽  
Vol 64 (9) ◽  
pp. 1296-1307 ◽  
Author(s):  
Alexandra S Whale ◽  
Gerwyn M Jones ◽  
Jernej Pavšič ◽  
Tanja Dreo ◽  
Nicholas Redshaw ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Copy Number ◽  
Digital Pcr ◽  
Measurement Procedure ◽  
Patient Treatment ◽  
Molecular Diagnostic ◽  
Reference Measurement ◽  
Reference Measurement Procedure ◽  
Wide Range ◽  
Primary Reference

Abstract BACKGROUND Genetic testing of tumor tissue and circulating cell-free DNA for somatic variants guides patient treatment of many cancers. Such measurements will be fundamental in the future support of precision medicine. However, there are currently no primary reference measurement procedures available for nucleic acid quantification that would support translation of tests for circulating tumor DNA into routine use. METHODS We assessed the accuracy of digital PCR (dPCR) for copy number quantification of a frequently occurring single-nucleotide variant in colorectal cancer (KRAS c.35G>A, p.Gly12Asp, from hereon termed G12D) by evaluating potential sources of uncertainty that influence dPCR measurement. RESULTS Concentration values for samples of KRAS G12D and wild-type plasmid templates varied by <1.2-fold when measured using 5 different assays with varying detection chemistry (hydrolysis, scorpion probes, and intercalating dyes) and <1.3-fold with 4 commercial dPCR platforms. Measurement trueness of a selected dPCR assay and platform was validated by comparison with an orthogonal method (inductively coupled plasma mass spectrometry). The candidate dPCR reference measurement procedure showed linear quantification over a wide range of copies per reaction and high repeatability and interlaboratory reproducibility (CV, 2%–8% and 5%–10%, respectively). CONCLUSIONS This work validates dPCR as an SI-traceable reference measurement procedure based on enumeration and demonstrates how it can be applied for assignment of copy number concentration and fractional abundance values to DNA reference materials in an aqueous solution. High-accuracy measurements using dPCR will support the implementation and traceable standardization of molecular diagnostic procedures needed for advancements in precision medicine.

Development of a reference measurement procedure for the determination of methylmercury in fish products

2009 ◽  
Vol 14 (5) ◽  
pp. 263-267 ◽  
Author(s):  
Sébastien Sannac ◽  
Paola Fisicaro ◽  
Guillaume Labarraque ◽  
Florence Pannier ◽  
Martine Potin-Gautier
Keyword(s):  
Measurement Procedure ◽  
Fish Products ◽  
Reference Measurement ◽  
Reference Measurement Procedure

scholarly journals Harmonization of Measurement Results of the Alcohol Biomarker Carbohydrate-Deficient Transferrin by Use of the Toolbox of Technical Procedures of the International Consortium for Harmonization of Clinical Laboratory Results

2014 ◽  
Vol 60 (7) ◽  
pp. 945-953 ◽  
Author(s):  
Cas Weykamp ◽  
Jos Wielders ◽  
Anders Helander ◽  
Raymond F Anton ◽  
Vincenza Bianchi ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Total Error ◽  
Measurement Procedure ◽  
Reference Measurement ◽  
Routine Measurement ◽  
Reference Measurement Procedure ◽  
Measurement Results ◽  
Laboratory Results ◽  
Alcohol Biomarker ◽  
Carbohydrate Deficient Transferrin

Abstract BACKGROUND The need for equivalent results of routine measurement procedures for the alcohol biomarker carbohydrate-deficient transferrin (CDT) has been recognized by the IFCC. This article describes a project to harmonize CDT as conducted by an IFCC working group initiated for this purpose. METHODS We used procedures for achieving harmonization as developed by the Consortium for Harmonization of Clinical Laboratory Results to assess the suitability of a candidate reference measurement procedure (cRMP), candidate reference materials (cRMs), and the success of efforts to achieve harmonization. RESULTS CDT measurement procedures in routine use showed good reproducibility (CV 1.1%–2.8%) and linearity (r > 0.990) with variable slopes (0.766–1.065) and intercepts (−0.34 to 0.92) compared to the cRMP. Heterogeneity after simulated harmonization was 4.7%. cRMs of frozen human native sera demonstrated commutability and 3-year stability for routine measurement procedures. The cRMP provided reproducible value assignment to cRMs with an expanded uncertainty (k = 2) of 0.03% at the 1.2% CDT level and 0.06% at the 4.4% CDT level. Harmonization efforts reduced the intermeasurement CV from 8.8% to 3.4%, allowed 99% recovery of the values assigned with the cRMP, and demonstrated 99% of results within the desirable allowable total error. Harmonization was less successful in samples with low CDT and high trisialotransferrin concentrations. CONCLUSIONS Harmonization of CDT is possible with frozen human native sera as cRMs with values assigned by use of the cRMP. We propose the cRMP as a candidate international conventional reference measurement procedure and cRMs as candidate international calibrators.

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