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Pregled bibliografske jedinice broj: 1049502

Analytical verification and comparison of chromogenic assays for dabigatran, rivaroxaban and apixaban determination on BCSXP and STA Compact Max analysers


Ćelap, Ivana; Margetić, Sandra; Mihić, Roman; Brčić, Marija
Analytical verification and comparison of chromogenic assays for dabigatran, rivaroxaban and apixaban determination on BCSXP and STA Compact Max analysers // Biochemia medica: the journal of The Croatian Society of Medical Biochemistry and Laboratory Medicine, 30 (2020), 1; 010706, 8 doi:10.11613/BM.2020.010706 (međunarodna recenzija, članak, znanstveni)


CROSBI ID: 1049502 Za ispravke kontaktirajte CROSBI podršku putem web obrasca

Naslov
Analytical verification and comparison of chromogenic assays for dabigatran, rivaroxaban and apixaban determination on BCSXP and STA Compact Max analysers

Autori
Ćelap, Ivana ; Margetić, Sandra ; Mihić, Roman ; Brčić, Marija

Izvornik
Biochemia medica: the journal of The Croatian Society of Medical Biochemistry and Laboratory Medicine (1330-0962) 30 (2020), 1; 010706, 8

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
chromogenic assay ; dabigatran ; rivaroxaban ; apixaban ; method comparison

Sažetak
Introduction: The aim of the study was to perform analytical verification and comparison of chromogenic assays for determination of dabigatran, rivaroxaban and apixaban concentration on BCSXP and STA Compact Max analysers. Materials and methods: Precision, linearity, measurement uncertainty estimation and determination of limit of blank, limit of determination and limit of quantification were calculated. Analytical performance specifications were set according to manufacturer specifications and literature data on between laboratory variability. Comparison of the methods was done using Bland-Altman and Passing-Bablok regression analysis. Results: Obtained results have shown acceptable precision on STA Compact Max only for dabigatran (CV = 3.5%) at lower concentration level comparing to manufacturer declaration (CV = 3.6%). On BCSXP, the highest coefficient of variation has been shown for apixaban (6.1%) at lower concentration level. Within laboratory precision was not met on STA Compact Max for all assays. Bland-Altman analysis has shown statistically significant bias for dabigatran (23.2%, 95%CI 11.2 – 35.3 ; P < 0.001) and apixaban (8.4%, 95%CI 1.2 – 15.6 ; P = 0.023). Passing-Bablok regression analysis has shown systematic and proportional deviation between methods for rivaroxaban (y = 6.52 (2.94 to 11.83) + 0.84 (0.80 to 0.89)x. Conclusion: Chromogenic assays for dabigatran, rivaroxaban and apixaban on BCSXP and STA Compact Max analysers are shown as methods with satisfactory long-term analytical performance specifications for determination of direct oral anticoagulants in clinical laboratories. However, we cannot recommend interchangeable use because of the significant bias between assays.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti, Farmacija



POVEZANOST RADA


Projekti:
HRZZ-IP-2016-06-8208 - Novi oralni antikoagulansi: povezanost koncentracije lijeka i antikoagulantnog učinka (LAB-NOAC) (Margetić, Sandra, HRZZ - 2016-06) ( POIROT)

Ustanove:
KBC "Sestre Milosrdnice"

Profili:

Avatar Url Ivana Ćelap (autor)

Avatar Url Sandra Margetić (autor)

Citiraj ovu publikaciju

Ćelap, Ivana; Margetić, Sandra; Mihić, Roman; Brčić, Marija
Analytical verification and comparison of chromogenic assays for dabigatran, rivaroxaban and apixaban determination on BCSXP and STA Compact Max analysers // Biochemia medica: the journal of The Croatian Society of Medical Biochemistry and Laboratory Medicine, 30 (2020), 1; 010706, 8 doi:10.11613/BM.2020.010706 (međunarodna recenzija, članak, znanstveni)
Ćelap, I., Margetić, S., Mihić, R. & Brčić, M. (2020) Analytical verification and comparison of chromogenic assays for dabigatran, rivaroxaban and apixaban determination on BCSXP and STA Compact Max analysers. Biochemia medica: the journal of The Croatian Society of Medical Biochemistry and Laboratory Medicine, 30 (1), 010706, 8 doi:10.11613/BM.2020.010706.
@article{article, year = {2020}, pages = {8}, DOI = {10.11613/BM.2020.010706}, chapter = {010706}, keywords = {chromogenic assay, dabigatran, rivaroxaban, apixaban, method comparison}, journal = {Biochemia medica: the journal of The Croatian Society of Medical Biochemistry and Laboratory Medicine}, doi = {10.11613/BM.2020.010706}, volume = {30}, number = {1}, issn = {1330-0962}, title = {Analytical verification and comparison of chromogenic assays for dabigatran, rivaroxaban and apixaban determination on BCSXP and STA Compact Max analysers}, keyword = {chromogenic assay, dabigatran, rivaroxaban, apixaban, method comparison}, chapternumber = {010706} }
@article{article, year = {2020}, pages = {8}, DOI = {10.11613/BM.2020.010706}, chapter = {010706}, keywords = {chromogenic assay, dabigatran, rivaroxaban, apixaban, method comparison}, journal = {Biochemia medica: the journal of The Croatian Society of Medical Biochemistry and Laboratory Medicine}, doi = {10.11613/BM.2020.010706}, volume = {30}, number = {1}, issn = {1330-0962}, title = {Analytical verification and comparison of chromogenic assays for dabigatran, rivaroxaban and apixaban determination on BCSXP and STA Compact Max analysers}, keyword = {chromogenic assay, dabigatran, rivaroxaban, apixaban, method comparison}, chapternumber = {010706} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE


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