Evaluation of fluorescence hs-CRP immunoassay for point-of-care testing.
BACKGROUND
C-reactive protein (CRP) is one of acute phase respondents that has been used to monitor infection and inflammation episodes. Recent studies have shown that high-sensitivity C-reactive protein (hs-CRP) is a potential risk predictor for future atherosclerosis and cardiovascular diseases (CVD).


METHODS
We previously developed a fluorescence-based immunochromatographic method for measuring hs-CRP concentrations (i-CHROMAtrade mark hs-CRP assay) in blood. Whole blood was mixed with detector buffer, and then loaded onto a test cartridge. After 10 min of incubation, the test cartridge was inserted and scanned for acquisition of fluorescence intensity in a laser fluorescence reader (i-CHROMAtrade mark reader). The fluorescence intensity was microprocessed and converted into the concentration of CRP in blood. The test result of 150 samples by the i-CHROMAtrade mark hs-CRP assay method was compared and evaluated with those by TBA 200FR turbidimetry and BN II nephelometry method. The Deming regression and the Bland-Altman difference plot analysis were used for comparison of hs-CRP test result.


RESULTS
The i-CHROMAtrade mark hs-CRP assay system exhibited a good linearity with in the whole measuring range (R=0.997). The imprecision of intra- and the inter-assay CVs (coefficient of variation) of assay system were CVs< 3% and < 5% in the range of 0.5-20 mg/l, respectively. The i-CHROMAtrade mark hs-CRP assay method correlated well with TBA 200FR turbidimetry and BN II nephelometry assay method (R=0.988, N=143 and R=0.989, N=143).


CONCLUSIONS
The i-CHROMAtrade mark hs-CRP assay system is comparable to those of other well-known fully automated hs-CRP assay and is suitable for point-of-care testing (POCT) in detection and quantification of hs-CRP.
Oh
Sang Wook
SW
BodiTech Med Inc., Chuncheon 200-160, South Korea.
Moon
Jung Dae
JD
Park
Sang Yeol
SY
Jang
Heuk Jae
HJ
Kim
Jae Hoon
JH
Nahm
Ki Bong
KB
Choi
Eui Yul
EY
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001161:Arteriosclerosis / Q000097:blood / Q000175:diagnosis; D002097:C-Reactive Protein / Q000032:analysis*; D002318:Cardiovascular Diseases / Q000097:blood / Q000175:diagnosis; D002845:Chromatography; D005260:Female; D005453:Fluorescence; D006801:Humans; D007118:Immunoassay; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems
D002097:C-Reactive Protein