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  • Lim, Yong Kwan  (3)
  • Pharmacy  (3)
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  • Pharmacy  (3)
  • 1
    Online Resource
    Online Resource
    Top-down and bottom-up approaches for the estimation of measurement uncertainty in coagulation assays
    Walter de Gruyter GmbH ; 2020
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 58, No. 9 ( 2020-08-27), p. 1525-1533
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 58, No. 9 ( 2020-08-27), p. 1525-1533
    Abstract: The assessment of measurement uncertainty (MU) in clinical laboratories is essential to the reliable interpretation of results in clinical laboratories. However, despite the introduction of various methods for the expression of uncertainty in measurement, the MUs of coagulation tests have not been extensively studied. The aim of this study was to quantify the MU of various coagulation assays according to international guidelines and to report an expected confidence in the quality of coagulation assays. Methods We selected activated partial thromboplastin time, international normalized ratio (INR), protein C/S, antithrombin, fibrinogen, and Factor V/VIII/X to quantify the MUs of two coagulation testing systems: ACL TOP 750 CTS (Instrumentation Laboratory, Bedford, MA, USA) and STA Compact (Diagnostica Stago, Asnières-sur-Seine, France). We used international standards and interlaboratory comparison results in accordance with international guidelines in a top-down approach to the assessment of MU. For INR, MU was estimated in a bottom-up approach using reference thromboplastin and certified plasmas. Results Top-down approaches resulted in MUs between 3.3% and 21.3% for each measurand. In the bottom-up approach, MUs of INR values ranged from 10.9% to 26.4% and showed an upward trend as INR increased. Conclusions In this study, we were successful in quantifying MU of coagulation assays using practical methods. Our results demonstrated that top-down and bottom-up approaches were adequate for coagulation assays. However, some assays showed significant biases against international standards; therefore, standardization would be necessary to ensure more reliable patient results.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2020-0038
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2020
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Evaluation of ichroma™ COVID-19 interferon gamma release assay for detection of vaccine-induced immunity in healthcare workers
    Walter de Gruyter GmbH ; 2023
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 61, No. 3 ( 2023-02-23), p. 503-509
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 61, No. 3 ( 2023-02-23), p. 503-509
    Abstract: We compared the performance of a new interferon gamma release assay (IGRA) format assay, the ichroma™ COVID-19 IGRA (IGRA-SARS), with that of the widely used QuantiFERON SARS-CoV-2 ELISA kit (QFN-SARS) in vaccinated healthcare workers (HCWs). Additionally, we analyzed the long-term changes in IGRA results after the final vaccine dose. Methods A total of 383 specimens from 281 HCWs were enrolled in this study, and the results of SARS-IGRA and QFN-SARS assays were compared. In addition, we performed the receive operator curve analysis to estimate the optimal cut-off value for IGRA-SARS. Results For all specimens, IGRA-SARS and QFN-SARS showed 75.7% and 64.2% of the positive results, respectively. The absolute agreement between IGRA-SARS and QFN-SARS was 80.0%, and the Fleiss’ κ value was 0.525, indicating moderate agreement. ROC curve analysis of the IGRA-SARS results showed a cut-off value of 〉 0.254 IU/mL, which was consistent with the manufacturer’s specifications. The positive rates of both IGRA assays decreased significantly after a postvaccination period of 6 months. Conclusions IGRA-SARS showed acceptable performance in the detection of vaccine-induced immunity against COVID-19; however, harmonization of IGRA assays has not yet been achieved. Additionally, the significant decline of positive rates of IGRA after the last vaccination would support the necessity of booster vaccination after a postvaccination period of 6 months.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2022-0914
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2023
    detail.hit.zdb_id: 1492732-9
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 3
    Online Resource
    Online Resource
    Prevalence and detection of Tropheryma whipplei in the stools of Korean patients with diarrhea using real-time PCRs
    Springer Science and Business Media LLC ; 2022
    In:  Annals of Clinical Microbiology and Antimicrobials Vol. 21, No. 1 ( 2022-12-06)
    Details
    In: Annals of Clinical Microbiology and Antimicrobials, Springer Science and Business Media LLC, Vol. 21, No. 1 ( 2022-12-06)
    Abstract: The prevalence of Tropheryma whipplei varies depending on age, region, and underlying disease. We estimated the prevalence of T. whipplei in the stools of Korean patients with diarrhea using real-time PCR (RT-PCR) and compared three RT-PCR targets, rpoB , hsp65 , and Dig15 . Methods A total of 1404 nucleic acid samples extracted from the stools of Korean patients with diarrhea were tested using an initial RT-PCR targeting T. whipplei -specific regions of 16S–23S rRNA intergenic spacer. Subsequently, the samples positive for the initial RT-PCR were tested using the follow-up RT-PCRs targeting rpoB , hsp65 , and Dig15 and analyzed by sequencing to confirm the presence of T. whipplei . We estimated the prevalence of T. whipplei and compared them according to gender and age. We also compared the performance of three targets in the follow-up RT-PCRs. Results T. whipplei was detected in 1.4% of all samples (20 of 1404), and there were no differences according to gender and age. In pediatric samples (≤ 19 years), T. whipplei was detected higher in children aged 6–19 than in those aged 1–5 (2.7% vs. 0.7%, P  = 0.01). Sensitivities of the rpoB , hsp65 , and Dig15 RT-PCR were 50.0%, 85.0%, and 95.0%, respectively; specificities were 100.0%, 100.0%, and 84.6%, respectively. Conclusions This is the first study that estimated the prevalence of T. whipplei in the stools of Korean patients with diarrhea. This study demonstrated the presence of T. whipplei in stools of Koreans, even though the bacterium was detected low. The RT-PCRs targeting hsp65 and Dig15 showed reliable performance, and a multiplex PCR including these targets is expected to be useful for T. whipplei detection.
    Type of Medium: Online Resource
    ISSN: 1476-0711
    URL: Article
    DOI: 10.1186/s12941-022-00543-1
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2097873-X
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
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