PMID- 38045154
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231205
IS  - 2405-8440 (Print)
IS  - 2405-8440 (Electronic)
IS  - 2405-8440 (Linking)
VI  - 9
IP  - 11
DP  - 2023 Nov
TI  - Comparison of ultra-performance liquid chromatography-tandem mass spectrometry 
      (UPLC-MS/MS) and enzyme-multiplied immunoassay technique (EMIT) for 
      quantification of voriconazole plasma concentration from Chinese patients.
PG  - e22015
LID - 10.1016/j.heliyon.2023.e22015 [doi]
LID - e22015
AB  - INTRODUCTION: Voriconazole (VRZ) is the recommended standard treatment for 
      life-threatening invasive aspergillosis. The plasma concentration of VRZ should 
      be determined to optimise treatment results and reduce side effects. This study 
      aimed to compare the correlation and concordance of ultra-performance liquid 
      chromatography-tandem mass spectrometry (UPLC-MS/MS) and enzyme-multiplied 
      immunoassay technique (EMIT) to determine VRZ plasma concentration in clinical 
      practice. METHODS: An isotopically labelled internal standard UPLC-MS/MS method 
      was established, validated, and subsequently applied to determine VRZ 
      concentration. The UPLC-MS/MS method was also compared with a commercial EMIT 
      method regarding results correlation and concordance. RESULTS: The calibration 
      curve of UPLC-MS/MS was linear from 0.1 to 10 mg/L, the inter- and intra-day 
      relative standard deviations (RSDs), and the stability of quality control samples 
      were less than 15 %, satisfying the Bioanalytical Method Validation Guidelines. A 
      total of 122 plasma samples were collected and analyzed using both methods. 
      UPLC-MS/MS and EMIT showed a high correlation (r = 0.9534), and Bland-Altman 
      analysis indicated a mean absolute bias of 1.035 mg/L and an average bias of 
      27.56 % between UPLC-MS/MS and EMIT. The paired Wilcoxon test and Bland-Altman 
      analysis revealed poor consistency between the two methods. Furthermore, we 
      compared the effects of different methods in clinical applications. Two threshold 
      values for treatment efficacy (1.0 mg/L) and safety (5.5 mg/L) were established, 
      and considerable discordance was observed between the original EMIT and 
      UPLC-MS/MS results at both thresholds (p < 0.05). Nevertheless, the adjusted EMIT 
      results were not inconsistent with the UPLC-MS/MS results regarding the efficacy 
      (p = 0.125) and safety (p = 1.0) thresholds. CONCLUSIONS: The isotopically 
      labelled internal standard UPLC-MS/MS method is established and well applied in 
      the clinical setting. A strong correlation but discordance was found between 
      UPLC-MS/MS and EMIT, indicating that switching from UPLC-MS/MS to EMIT was 
      unsuitable. However, the adjusted EMIT results may serve as a reliable surrogate 
      when UPLC-MS/MS results cannot be obtained when necessary.
CI  - (c) 2023 The Authors. Published by Elsevier Ltd.
FAU - Yu, Mingjie
AU  - Yu M
AD  - Pharmacy Department, Southwest Hospital of Army Medical University, Chongqing, 
      400038, People's Republic of China.
FAU - Yang, Jun
AU  - Yang J
AD  - Pharmacy Department, Southwest Hospital of Army Medical University, Chongqing, 
      400038, People's Republic of China.
FAU - Xiong, Lirong
AU  - Xiong L
AD  - Pharmacy Department, Southwest Hospital of Army Medical University, Chongqing, 
      400038, People's Republic of China.
FAU - Zhan, Shipeng
AU  - Zhan S
AD  - Pharmacy Department, Southwest Hospital of Army Medical University, Chongqing, 
      400038, People's Republic of China.
FAU - Cheng, Lin
AU  - Cheng L
AD  - Pharmacy Department, Southwest Hospital of Army Medical University, Chongqing, 
      400038, People's Republic of China.
FAU - Chen, Yongchuan
AU  - Chen Y
AD  - Pharmacy Department, Southwest Hospital of Army Medical University, Chongqing, 
      400038, People's Republic of China.
FAU - Liu, Fang
AU  - Liu F
AD  - Pharmacy Department, Southwest Hospital of Army Medical University, Chongqing, 
      400038, People's Republic of China.
LA  - eng
PT  - Journal Article
DEP - 20231113
PL  - England
TA  - Heliyon
JT  - Heliyon
JID - 101672560
PMC - PMC10692776
OTO - NOTNLM
OT  - Concordance
OT  - EMIT
OT  - Therapeutic drug monitoring
OT  - UPLC-MS/MS
OT  - Voriconazole
COIS- The authors declare that they have no known competing financial interests or 
      personal relationships that could have appeared to influence the work reported in 
      this paper.
EDAT- 2023/12/04 06:42
MHDA- 2023/12/04 06:43
PMCR- 2023/11/13
CRDT- 2023/12/04 04:30
PHST- 2023/07/12 00:00 [received]
PHST- 2023/09/15 00:00 [revised]
PHST- 2023/11/01 00:00 [accepted]
PHST- 2023/12/04 06:43 [medline]
PHST- 2023/12/04 06:42 [pubmed]
PHST- 2023/12/04 04:30 [entrez]
PHST- 2023/11/13 00:00 [pmc-release]
AID - S2405-8440(23)09223-X [pii]
AID - e22015 [pii]
AID - 10.1016/j.heliyon.2023.e22015 [doi]
PST - epublish
SO  - Heliyon. 2023 Nov 13;9(11):e22015. doi: 10.1016/j.heliyon.2023.e22015. 
      eCollection 2023 Nov.