Analytical Performance of a New Immunoturbidimetric Assay for von Willebrand Factor (VWF) Activity Testing.
Journal
Clinical laboratory
ISSN: 1433-6510
Titre abrégé: Clin Lab
Pays: Germany
ID NLM: 9705611
Informations de publication
Date de publication:
01 Apr 2019
01 Apr 2019
Historique:
entrez:
11
4
2019
pubmed:
11
4
2019
medline:
4
9
2019
Statut:
ppublish
Résumé
Von Willebrand disease requires laboratory confirmation with quantitative and qualitative measurements of von Willebrand factor (VWF). Qualitative VWF-activity (VWF-Ac) tests have poor inter- and intra-laboratory reproducibility with coefficients of variation (CVs) as high as 64%, often lacking accuracy at low VWF-Ac levels. This study evaluated the recently launched immunoturbidometric STAGO® STA-VWF:RCo® reagent for VWF-Ac. Accuracy was evaluated on 32 samples by comparing results using the Siemens® Innovance® reagent. An intra-run reproducibility study was performed on controls. Linearity and lower limit of detection was studied on external-quality-assurance (EQA) material with a known VWF-Ac level. STA-VWF:RCo® reagent results were within clinical interpretation agreement with Siemens® Innovance®. The reproducibility study yielded % CVs of 8.41 for normal and 11.46 for abnormal controls and the assay was linear between 73 and 14.6% and remained linear to 2% with extrapolation. The STAGO® STA-VWF:RCo® reagent showed clinically meaningful accuracy and acceptable precision.
Sections du résumé
BACKGROUND
BACKGROUND
Von Willebrand disease requires laboratory confirmation with quantitative and qualitative measurements of von Willebrand factor (VWF). Qualitative VWF-activity (VWF-Ac) tests have poor inter- and intra-laboratory reproducibility with coefficients of variation (CVs) as high as 64%, often lacking accuracy at low VWF-Ac levels.
METHODS
METHODS
This study evaluated the recently launched immunoturbidometric STAGO® STA-VWF:RCo® reagent for VWF-Ac. Accuracy was evaluated on 32 samples by comparing results using the Siemens® Innovance® reagent. An intra-run reproducibility study was performed on controls. Linearity and lower limit of detection was studied on external-quality-assurance (EQA) material with a known VWF-Ac level.
RESULTS
RESULTS
STA-VWF:RCo® reagent results were within clinical interpretation agreement with Siemens® Innovance®. The reproducibility study yielded % CVs of 8.41 for normal and 11.46 for abnormal controls and the assay was linear between 73 and 14.6% and remained linear to 2% with extrapolation.
CONCLUSIONS
CONCLUSIONS
The STAGO® STA-VWF:RCo® reagent showed clinically meaningful accuracy and acceptable precision.
Identifiants
pubmed: 30969088
doi: 10.7754/Clin.Lab.2018.180919
doi:
Substances chimiques
von Willebrand Factor
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM