Development and Evaluation of Up-Converting Phosphor Technology-Based Lateral Flow Assay for Quantitative Detection of NT-proBNP in Blood.
A newly assay, up-converting phosphor technology-based lateral flow (UPT-LF) assay, was developed for rapid and quantitative detection of N-terminal fragment of B-type natriuretic peptide precursor (NT-proBNP), one of the most important serum molecular maker of heat failure, in plasma samples as a point of care testing (POCT) method for diagnosis of acute heart failure. Human plasma from 197 patients with acute heart failure and 200 healthy controls was assessed using the UPT-LF assay, in a comparison with a Roche Elecsys assay. The limit of detection of the UPT-LF assay, with a coefficient of variation (CV) of less than 15%, was 116 ng/L, which is lower than the clinical diagnosis cutoff (150 ng/mL). The linear range was 50-35,000 ng/L. The CVs were less than 10% for both UPT-LF and Roche Elecsys assays for plasma samples under different storages, demonstrating the good stability and reproducibility. There are certain linear correlations between the results of UPT-LF and Roche Elecsys assay for EDTA-K2 and heparin-anticoagulated plasma, as well as for serum samples. For UPT-LF assay, there is a significant correlation between the values derived from analysis of EDTA-K2 and heparin-anticoagulated plasma samples (R = 0.995). No statistically significant difference was found between serum and plasma samples for UPT-LF assay. Our results demonstrate that NT-proBNP levels in healthy adults are elevated with age and had a relationship with sex, and with the age increase the NT-proBNP levels of females are significantly higher than those of males (p<0.01). The UPT-LF assay has a high reproducibility, stability, sensitivity, specificity, and is consistent with Roche Elecsys assay, and therefore it could be used as a POCT method for the quantitative detection of NT-proBNP in blood for clinical diagnosis and research of acute heart failure.
Clinical laboratory, General Hospital of Chinese People's Armed Police Forces, Hai Dian District, Beijing, China.
Xiaoli
X
Yang
Clinical laboratory, General Hospital of Chinese People's Armed Police Forces, Hai Dian District, Beijing, China.
Liping
L
Liu
Clinical laboratory, General Hospital of Chinese People's Armed Police Forces, Hai Dian District, Beijing, China.
Qingfang
Q
Hao
Clinical laboratory, General Hospital of Chinese People's Armed Police Forces, Hai Dian District, Beijing, China.
Deyong
D
Zou
Clinical laboratory, General Hospital of Chinese People's Armed Police Forces, Hai Dian District, Beijing, China.
Xiaoli
X
Zhang
Clinical laboratory, General Hospital of Chinese People's Armed Police Forces, Hai Dian District, Beijing, China.
Liping
L
Zhang
Clinical laboratory, General Hospital of Chinese People's Armed Police Forces, Hai Dian District, Beijing, China.
Hongmei
H
Li
Beijing Hotgen Biotech Co. Ltd., Da Xing Industrial Development Zone, Beijing, China.
Yong
Y
Qiao
Beijing Hotgen Biotech Co. Ltd., Da Xing Industrial Development Zone, Beijing, China.
Huansheng
H
Zhao
Laboratory of Analytical Microbiology, State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Beijing, P.R. China.|Beijing Key Laboratory of POCT for Bioemergency and Clinic (No. BZ0329), Beijing, P.R. China.
Lei
L
Zhou
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D005260:Female; D006333:Heart Failure / Q000097:blood; D006801:Humans; D057230:Limit of Detection; D008297:Male; D013677:Medical Laboratory Science / Q000295:instrumentation / Q000379:methods; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood*; D010446:Peptide Fragments / Q000097:blood*; D019095:Point-of-Care Systems; D011934:Reagent Strips; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult
D010446:Peptide Fragments; D011934:Reagent Strips; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain