PMID- 36010280
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220830
IS  - 2075-4418 (Print)
IS  - 2075-4418 (Electronic)
IS  - 2075-4418 (Linking)
VI  - 12
IP  - 8
DP  - 2022 Aug 10
TI  - Reference Interval for the Axis-Shield Clinical Chemistry Heparin-Binding Protein 
      Assay.
LID - 10.3390/diagnostics12081930 [doi]
LID - 1930
AB  - The newly developed Axis-Shield clinical chemistry heparin-binding protein (HBP) 
      assay (Axis-Shield Diagnostics Ltd., Dundee, Scotland) can be applied to fully 
      automated platforms. We aimed to establish a reference interval (RI) of HBP using 
      the Axis-Shield HBP assay, and to evaluate the analytical performance of this 
      assay. An RI was established in 212 sodium citrated plasma samples using the 
      non-parametric method (2.5th and 97.5th percentiles). Precision, linearity, and 
      carry-over were evaluated according to the Clinical and Laboratory Standards 
      Institute guidelines. The RI of HBP was between 5.3 ng/mL and 171.0 ng/mL, which 
      could be applied regardless of gender and age. Percentage coefficients of 
      variations (%CVs) of repeatability and within-laboratory precision were 4.9% and 
      6.3%, respectively, for low-concentration control and 1.6% and 3.0%, 
      respectively, for high-concentration control. The linearity was excellent 
      (coefficient of determination (R(2)) = 0.99), and the carry-over rate was 
      negligible (0.05%). This is the first study to establish an RI of HBP using the 
      newly developed and fully automated Axis-Shield HBP assay. The Axis-Shield HBP 
      assay showed an acceptable level of analytical performance and could be used to 
      measure HBP concentrations effectively in routine clinical practice. Further 
      studies are awaited to evaluate the clinical utility of HBP using this automated 
      assay.
FAU - Yoon, Sumi
AU  - Yoon S
AUID- ORCID: 0000-0001-7529-1613
AD  - Department of Laboratory Medicine, Chung-Ang University College of Medicine, 
      Seoul 06973, Korea.
FAU - Hur, Mina
AU  - Hur M
AUID- ORCID: 0000-0002-4429-9978
AD  - Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul 
      05030, Korea.
FAU - Kim, Hanah
AU  - Kim H
AUID- ORCID: 0000-0002-3266-638X
AD  - Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul 
      05030, Korea.
FAU - Moon, Hee-Won
AU  - Moon HW
AUID- ORCID: 0000-0001-9509-6073
AD  - Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul 
      05030, Korea.
FAU - Yun, Yeo-Min
AU  - Yun YM
AUID- ORCID: 0000-0002-5485-8331
AD  - Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul 
      05030, Korea.
LA  - eng
PT  - Journal Article
DEP - 20220810
PL  - Switzerland
TA  - Diagnostics (Basel)
JT  - Diagnostics (Basel, Switzerland)
JID - 101658402
PMC - PMC9406967
OTO - NOTNLM
OT  - Axis-Shield clinical chemistry heparin-binding protein assay
OT  - analytical performance
OT  - heparin-binding protein
OT  - reference interval
COIS- The authors report no conflicts of interest. The authors alone are responsible 
      for the content and writing of the paper.
EDAT- 2022/08/27 06:00
MHDA- 2022/08/27 06:01
PMCR- 2022/08/10
CRDT- 2022/08/26 01:10
PHST- 2022/07/26 00:00 [received]
PHST- 2022/08/09 00:00 [accepted]
PHST- 2022/08/26 01:10 [entrez]
PHST- 2022/08/27 06:00 [pubmed]
PHST- 2022/08/27 06:01 [medline]
PHST- 2022/08/10 00:00 [pmc-release]
AID - diagnostics12081930 [pii]
AID - diagnostics-12-01930 [pii]
AID - 10.3390/diagnostics12081930 [doi]
PST - epublish
SO  - Diagnostics (Basel). 2022 Aug 10;12(8):1930. doi: 10.3390/diagnostics12081930.