J Lab Med Qual Assur.  2011 Dec;33(2):75-82.

Evaluation of HUBI-QUANPRO Point-of-Care Testing for Cardiac Markers

Affiliations
  • 1Catholic Lab Development & Evaluation Center, Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. yeongsik@catholic.ac.kr

Abstract

BACKGROUND
Recently, quantitative point-of-care testing (POCT) for cardiac markers using colloidal gold particles was developed in Korea. We evaluated the analytical performance of the HUBI-QUANPRO (Humasis, Korea) assay in comparison with two other assays.
METHODS
We evaluated the analytical precision and linearity of HUBI-QUANPRO creatine kinase (CK)-MB, cardiac troponin I (cTnI), and B-type natriuretic peptides (BNP). HUBI-QUANPRO assay was compared with ADVIA Centaur (Siemens, Germany) and Triage (Biosite Diagnostics, USA) assays by using 100 blood samples. In addition, we evaluated the interference of hemoglobin on the HUBI-QUANPRO assay.
RESULTS
The coefficients of variation of HUBI-QUANPRO CK-MB, cTnI, and BNP were 7.5-9.7%, 12.0-17.4%, and 14.7-15.7%, respectively. The linearity ranges of HUBI-QUANPRO CK-MB, cTnI, and BNP were 4.7-27.8 ng/mL, 0.76-6.51 ng/mL, and 76.2-762.2 ng/mL, respectively. The comparison study showed no significant difference among them. When 0.5% hemolysis occurred, remarkable hemoglobin interference was found in the three markers resulting in underestimation of the concentrations.
CONCLUSIONS
HUBI-QUANPRO CK-MB and BNP showed good analytical performances compared with the other two assays. Hemoglobin interference was noted in the HUBI-QUANPRO assay, especially more in BNP. Although the linearity range of cTnI was narrow, its agreement rate with ADVIA Centaur was good, thus the HUBI-QUANPRO assay could be useful as a quantitative POCT for cardiac markers in the emergency department.

Keyword

CK-MB; Cardiac troponin I; Brain natriuretic peptide (BNP); Point-of-care testing (POCT)

MeSH Terms

Creatine Kinase
Emergencies
Gold Colloid
Hemoglobins
Hemolysis
Korea
Natriuretic Peptides
Triage
Troponin I
Creatine Kinase
Gold Colloid
Hemoglobins
Natriuretic Peptides
Troponin I
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