GLORIA

GEOMAR Library Ocean Research Information Access

X

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
Filter
  • Walter de Gruyter GmbH  (36)
  • Pharmacy  (36)
Material
Publisher
  • Walter de Gruyter GmbH  (36)
Person/Organisation
Language
Years
FID
  • Pharmacy  (36)
  • 1
    Online Resource
    Online Resource
    Reference intervals of 14 biochemical markers for children and adolescence in China: the PRINCE study
    Walter de Gruyter GmbH ; 2022
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 60, No. 10 ( 2022-09-27), p. 1627-1639
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 60, No. 10 ( 2022-09-27), p. 1627-1639
    Abstract: The Pediatric Reference Intervals in China (PRINCE) was initiated to establish the reference intervals (RIs) of Chinese children, as well as to make it possible to compare the variability of biochemical markers among countries internationally. Methods Healthy participants, aged up to 20 years, from 11 provinces across China, were enrolled in PRINCE and according to a standard screening procedure, that included a questionnaire survey, physical examinations and laboratory tests. Fasting venous blood specimens were collected. All serum specimens were analyzed with Cobas C702 in the center laboratory, i.e. clinical laboratory of Beijing Children’s Hospital, with certified qualification (ISO15189). The nonparametric method recommended by Clinical Laboratory Standards Institute guidelines, was used to calculate the age- and sex-specified RIs. Results Among the 15,150 participants enrolled, 12,352 children (6,093 males and 6,259 females) were included to calculate RIs. The RIs for total protein, albumin, globulin, calcium, phosphate, potassium, sodium, chlorine, alkaline phosphatase, γ-glutamyl transpeptadase, alanine aminotransferase, aspartate aminotransferase, creatinine and urea were established by age- or sex-partitions. Most biochemical markers displayed larger variability and higher dispersion during the periods between 28 days and 1 year old, and included 4–6 age partitions commonly during 1 to 〈 20 years old. In addition, differences of RIs between sexes usually occurs around the initiation of puberty at 12–13 years old. Conclusions The age- and sex-specified RIs of 14 biochemical markers in PRINCE study can provide a solid reference, which will be transferred into relevant RIs for other clinical laboratory’s platforms according to the CLSI guidelines.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2022-0299
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2022
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 2
    Online Resource
    Online Resource
    Exploration of suitable external quality assessment materials for serum C-peptide measurement
    Walter de Gruyter GmbH ; 2023
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 61, No. 9 ( 2023-08-28), p. 1597-1604
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 61, No. 9 ( 2023-08-28), p. 1597-1604
    Abstract: To find suitable external quality assessment (EQA) materials for serum C-peptide, we evaluated the commutability of five types of processed materials. Methods Seventy-four individual serum samples and 12 processed samples including three EQA samples currently in use, frozen human serum pools (FHSP), and three other kinds of processed samples were prepared by dissolving WHO International Standard Reagent for C-peptide (WHO ISR 13/146) in three different matrixes: 0.05 % bovine serum albumin, fetal bovine serum and human serum pools. Samples were analyzed using the isotope dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) method and six widely used immunoassays. The commutabilities of processed materials were assessed according to the difference in bias approach recommended by the IFCC. And the short- and long-term stability of FHSP samples at different temperatures were also evaluated. Results Out of the five kinds of processed materials, FHSP samples were commutable on most assays. In contrast, the EQA materials currently in use were only commutable on a few immunoassays. Additionally, processed materials derived from WHO ISR 13/146 were found to be un-commutable on over half of immunoassays. The FHSP samples could be stably stored at 4 and −20 °C for at least 16 days, and at −80 °C for at least 1 year, but at room temperature only for 12 h. Conclusions With clarified commutability and stability information, the human serum pool samples along with the developed ID-LC-MS/MS method could be used in the EQA program to promote the comparability among laboratories for C-peptide measurement in China.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2023-0215
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2023
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 3
    Online Resource
    Online Resource
    Evaluation of serum electrolytes measurement through the 6-year trueness verification program in China
    Walter de Gruyter GmbH ; 2021
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 59, No. 1 ( 2021-01-26), p. 107-116
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 59, No. 1 ( 2021-01-26), p. 107-116
    Abstract: The National Center for Clinical Laboratories (NCCL) in China initiated a serum electrolyte trueness verification (ETV) program in 2014 for measurement standardization. Methods Every year, two levels of fresh frozen commutable serum samples determined by inductively coupled plasma mass spectrometry (ICP-MS) reference methods were transported to participating clinical laboratories for the measurement of sodium, potassium, calcium and magnesium. Both samples were measured 15 times in 3 days, and the mean values and coefficient variations (CVs) were calculated from the results. The tolerance limits of trueness (bias), precision (CV) and accuracy (TE) based on the biological variation database were used as the evaluation criteria. The overall trend of the ETV program over 6 years was surveyed by calculating the pass rates of the participating laboratories. The mean bias, inter-laboratory CV, and TE of all laboratory results were analysed. Furthermore, homogeneous and heterogeneous systems were compared, and the bias and CV results of mainstream analysis systems were analysed. Results Pass rates of the three quality specifications increased, and the overall mean bias and inter-laboratory CVs decreased. The homogeneous system was superior to the heterogeneous system for calcium and magnesium measurements. For sodium, potassium, calcium and magnesium, the minimum bias corresponded to Hitachi, Siemens, Beckman AU and Roche, respectively. For inter-laboratory robust CVs, no obvious differences were observed between each peer group. Conclusions The commutable ETV materials assigned via reference methods can evaluate the accuracy and reproducibility of an individual laboratory and the calibration traceability and uniformity between laboratories for measurements.
    Type of Medium: Online Resource
    ISSN: 1437-4331 , 1434-6621
    URL: Article
    DOI: 10.1515/cclm-2020-0355
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2021
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 4
    Online Resource
    Online Resource
    Comparison of four different immunoassays and a rapid isotope-dilution liquid chromatography-tandem mass spectrometry assay for serum folate
    Walter de Gruyter GmbH ; 2022
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 60, No. 9 ( 2022-08-26), p. 1393-1402
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 60, No. 9 ( 2022-08-26), p. 1393-1402
    Abstract: Accurate measurement of serum folate is essential for the diagnosis and management of various disorders. This study aims to investigate the between-method differences of four immunoassays and a rapid isotope-dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) method. Methods Roche Cobas (USA), Abbott Alinity i2000 (USA), Beckman Coulter Access (USA), Mindray CL-6000i (China), and the ID-LC-MS/MS method were compared using 46 human serum samples. The results were analysed by Passing–Bablok regressions and Bland–Altman plots. A bias of 13.31% based on biological variation was used as the bias criterion. Results All the within-run and total coefficients of variation (CVs) met the specification. The folate concentrations determined by all the assays were significantly different (p=0.0028). All assays had correlation coefficients over 0.97 with each other. The 95% confidence intervals (CIs) for the slope seldom contained 1 and few 95% CIs for the intercept contained 0 in the regression equations. Compared to ID-LC-MS/MS, the biases of all assays ranged from −20.91 to 13.56 nmol/L, and the mean relative biases ranged from −9.85 to 40.33%. The predicted mean relative biases at the medical decision levels rarely met the criterion. Conclusions Assays for serum folate had good correlations with each other but lacked good agreement. The accuracy and consistency of assays for serum folate should be measured and assessed routinely. Standardization work to improve the accuracy of serum folate assays, such as the extension of traceability to reference methods or materials, calibration standardization efforts, and assay-adjusted cut-offs should be promoted.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2021-1283
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2022
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 5
    Online Resource
    Online Resource
    Ligand binding assay-related underestimation of 25-hydroxyvitamin D in pregnant women exaggerates the prevalence of vitamin D insufficiency
    Walter de Gruyter GmbH ; 2023
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 61, No. 2 ( 2023-01-27), p. e29-e32
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 61, No. 2 ( 2023-01-27), p. e29-e32
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2022-0899
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2023
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 6
    Online Resource
    Online Resource
    Imprecision remains to be improved in the measurement of serum cystatin C with heterogeneous systems
    Walter de Gruyter GmbH ; 2023
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 61, No. 8 ( 2023-07-26), p. 1455-1462
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 61, No. 8 ( 2023-07-26), p. 1455-1462
    Abstract: Except for the large bias of some measurement systems for serum cystatin C (CysC) measurements, unacceptable imprecision has been observed for the heterogenous system. This study analyzed the external quality assessment (EQA) results in 2018–2021 to provide an insight into the imprecision of CysC assays. Methods Five EQA samples were sent to participating laboratories every year. Participants were divided into reagent/calibrator-based peer groups, for which the robust mean of each sample and robust coefficient of variation (CV) were calculated by Algorithm A from ISO 13528. Peers with more than 12 participants per year were selected for further analysis. The limit of CV was determined to be 4.85% based on clinical application requirements. The concentration-related effect on CVs was investigated using logarithmic curve fitting; the difference in medians and robust CVs between instrument-based subgroups was also evaluated. Results The total number of participating laboratories increased from 845 to 1,695 in four years and heterogeneous systems remained the mainstream (≥85%). Of 18 peers with ≥12 participants, those using homogeneous systems showed relatively steady and small CVs over four years, with the mean four-year CVs ranging from 3.21 to 3.68%. Some peers using heterogenous systems showed reduced CVs over four years, while 7/15 still had unacceptable CVs in 2021 (5.01–8.34%). Six peers showed larger CVs at the low or high concentrations, and some instrument-based subgroups presented greater imprecision than others. Conclusions More efforts should be made to improve the imprecision of heterogeneous systems for CysC measurement.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2022-1299
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2023
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 7
    Online Resource
    Online Resource
    Standardization of measurement procedures for serum uric acid: 8-year experience from Category 1 EQA program results in China
    Walter de Gruyter GmbH ; 2019
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 57, No. 4 ( 2019-03-26), p. 476-482
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 57, No. 4 ( 2019-03-26), p. 476-482
    Abstract: Serum uric acid is a critical clinical indicator, and results without equivalence among laboratories cause troubles for disease diagnosis and patient management. External quality assessment (EQA) is a common tool for enhancing harmonization/standardization, therefore, the National Center for Clinical Laboratories in China has initiated a category 1 EQA for serum uric acid measurement since 2010 for evaluating its process of standardization. Methods Commutable EQA samples with target values assigned by reference measurement procedures were sent to participant laboratories. Both concentrations were measured 15 times in 3 days then means and intra-laboratory coefficient of variations (CVs) were reported. Biological variation criteria were used for analysis with CLIA88 criteria as a comparison. Results A total of 1250 laboratories participated in EQA programs from 2010 to 2017, pass rates calculated according to desirable specifications in biological variation database were on a rise overall and inter-laboratory mean bias and CVs were on a decrease. Homogeneous systems showed better inter-laboratory CVs and pass rates than heterogeneous systems. For the mostly used measurement systems; Abbott, Beckman, Roche Modular, Siemens and Hitachi showed desirable performances other than Roche Cobas, according to biological variation criteria. Conclusions Our study provides reliable information on the standardization of measurement procedures for serum uric acid for manufacturers and laboratories. Further improvements for standardization are still needed to make laboratories more patient-centered.
    Type of Medium: Online Resource
    ISSN: 1437-4331 , 1434-6621
    URL: Article
    DOI: 10.1515/cclm-2018-0274
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2019
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 8
    Online Resource
    Online Resource
    Serum triglyceride measurements: the commutability of reference materials and the accuracy of results
    Walter de Gruyter GmbH ; 2017
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 55, No. 9 ( 2017-01-1)
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 55, No. 9 ( 2017-01-1)
    Abstract: We aimed to evaluate the commutability of external quality assessment (EQA) materials, aqueous solutions, and commercial reference materials (calibrators and controls), and the accuracy of routine systems for serum triglyceride measurements. Methods According to the clinical and laboratory standards institute (CLSI) EP14-A3 protocol, we analyzed 43 fresh patient specimens and 32 processed materials including lyophilized samples, human serum pools, liquid reagents, swine sera and aqueous solutions by 14 routine methods (evaluated methods) and an isotope dilution liquid chromatography tandem mass spectrometry method (ID-LC/MS/MS) (comparative method). The accuracy of the routine method was evaluated by analyzing the absolute bias, relative bias, and the bias at three medical decision levels based on CLSI EP9-A3. Results Frozen serum samples and swine sera were commutable for all of the assays. The EQA/PT materials, commercial calibrators and control materials showed matrix effects differently on routine methods. The aqueous glycerol solutions were generally noncommutable for routine method. All except one routine analytical systems met the National Cholesterol Education Program (NCEP) recommended analytical performance guideline analytical quality criteria for total error. Conclusions Matrix effects and calibration biases existed in measurements of serum triglyceride. Continued efforts are needed to improve the accuracy and comparability of routine measurements.
    Type of Medium: Online Resource
    ISSN: 1437-4331 , 1434-6621
    URL: Article
    DOI: 10.1515/cclm-2016-0682
    Language: Unknown
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2017
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 9
    Online Resource
    Online Resource
    Poor comparability of plasma renin activity measurement in determining patient samples: the status quo and recommendations for harmonization
    Walter de Gruyter GmbH ; 2023
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 61, No. 10 ( 2023-09-26), p. 1770-1779
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 61, No. 10 ( 2023-09-26), p. 1770-1779
    Abstract: This study aims to investigate and update the consistency and comparability of plasma renin activity (PRA) assays in measuring clinical samples. The contributions of recalibration, blank subtraction, and incubation strategies to interchangeability were also explored. Methods Five different laboratories were evaluated using forty-six individual plasma samples, including four liquid chromatography-tandem mass spectrometry (LC‒MS/MS) assays and one chemiluminescence immunoassay (CLIA). Spearman correlation coefficient (R), Passing–Bablok regression, and Bland‒Altman plot analyses were used to evaluate the consistency among assays. Consistency before and after recalibration, blank subtraction, and incubation strategy unification was compared. Results A good correlation was observed among all assays (R 〉 0.93). None of the samples measured by all assays showed coefficient variation (CV) 〈 10 %, and 37 % of samples showed overall CVs 〉 20 %. The 95 % confidence intervals (CIs) for slopes did not contain 1 for most assay pairs. Large relative biases (−85.1–104.2 %) were found, and 76 % (52–93 %) of samples had unacceptable biases. Recalibration reduced the calibration bias. Ignoring blank subtraction improved the comparability across all assays while unifying incubation did not. Conclusions The interchangeability of PRA measurement was unsatisfying. Harmonization on calibrator and ignoring blank were recommended. Unifying incubation strategy was unnecessary.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2023-0117
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2023
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 10
    Online Resource
    Online Resource
    Quantification of hemoglobin A1c by off-line HPLC separation and liquid chromatography-tandem mass spectrometry: a modification of the IFCC reference measurement procedure
    Walter de Gruyter GmbH ; 2016
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 54, No. 4 ( 2016-01-1)
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 54, No. 4 ( 2016-01-1)
    Abstract: The quality of hemoglobin A The samples were prepared and enzymatically cleaved according to the IFCC HbA The total analysis time which includes the off-line HPLC separation and the LC/MS/MS analysis was reduced by at least 65% compared to the existing IFCC method. The transitions of This method is an efficient and reliable procedure for the determination of HbA
    Type of Medium: Online Resource
    ISSN: 1437-4331 , 1434-6621
    URL: Article
    DOI: 10.1515/cclm-2015-0365
    Language: Unknown
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2016
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...