Analytical evaluation of the novel VITROS BRAHMS procalcitonin immunoassay.
Scand J Clin Lab Invest
; 80(7): 541-545, 2020 Nov.
Article
in English
| MEDLINE | ID: covidwho-896893
ABSTRACT
To determine the analytical performance of Novel VITROS BRAHMS Procalcitonin Immunoassay on VITROS 3600 and correlation with BRAHMS PCT sensitive KRYPTOR reference method. Analytical performances including imprecision studies, linearity, limit of detection (LoD) and determination of hemolysis index were performed for VITROS BRAHMS PCT assay. Imprecision was assessed on plasma pool and internal control with 2 levels. The method comparison was performed using 162 plasma obtained from clinical departments. The total imprecision was acceptable and all CV were <5%. The LoD was in accordance with manufacturer's claims. The equation of linearity in the lower range was found to be y = 1.0014x - 0.0091, with r2 = 1. No interference to hemoglobin up to 11 g/L was observed. Correlation studies showed a good correlation between PCT measurements using VITROS BRAHMS PCT assay against KRYPTOR system including for values lower than 2 µg/L. The novel VITROS BRAHMS PCT assay from OrthoClinical Diagnostics shows analytical performances acceptable for clinical use. In addition, the concordance with KRYPTOR method was fine at all clinical cut-offs.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Immunoassay
/
Procalcitonin
Type of study:
Diagnostic study
/
Experimental Studies
/
Prognostic study
Limits:
Humans
Language:
English
Journal:
Scand J Clin Lab Invest
Year:
2020
Document Type:
Article
Affiliation country:
00365513.2020.1804071
Similar
MEDLINE
...
LILACS
LIS