Clinical advantage of highly sensitive on-chip immunoassay for fucosylated fraction of alpha-fetoprotein in patients with hepatocellular carcinoma.
BACKGROUND
Alpha-fetoprotein (AFP) has been widely used as a diagnostic master for hepatocellular carcinoma (HCC), and the fucosylated fraction of AFP (AFP-L3) has been reported to be a specific marker for HCC. However, AFP-L3 has not always been reliable in cases with low serum AFP concentrations. Recently, a novel automated immunoassay for AFP-L3, the micro-total analysis system (μ-TAS), has been developed.


OBJECTIVE
The aim of this study is to evaluate the clinical usefulness of μ-TAS AFP-L3.


METHODS
Serum AFP-L3 was measured in 295 patients with HCC and in 350 with benign liver diseases. The diagnostic accuracy of μ-TAS AFP-L3 was compared with that of the conventional assay (liquid-phase binding assay; LiBASys). The relationship between μ-TAS AFP-L3 and clinical features was investigated.


RESULTS
When the cutoff value was set at 7%, the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of μ-TAS AFP-L3 were 60.0%, 90.3%, 76.4%, 83.9%, and 72.8%, respectively. Its sensitivity was particularly good (41.1%) in HCC subgroups with lower AFP concentrations (<20 ng/ml). The positivity rates for μ-TAS AFP-L3 were higher at each tumor stage than those of LiBASys AFP-L3 (μ-TAS/LiBASys: stage I, 44.2%/16.3%; stage II, 52.9%/37.5%; stage III, 66.4%/44.5%; stage IV, 82.8%/65.5%).


CONCLUSIONS
μ-TAS AFP-L3 is more sensitive for discriminating HCC than the conventional LiBASys AFP-L3, particularly in subgroups with lower AFP concentrations and early-stage HCC.
Tamura
Yasushi
Y
Division of Gastroenterology and Hepatology, Niigata University Graduate School of Medical and Dental Sciences, 757 Asahimachi Dori-1-Bancho, Chuo-ku, Niigata 951-8520, Japan. ytamura@med.niigata-u.ac.jp
Igarashi
Masato
M
Kawai
Hirokazu
H
Suda
Takeshi
T
Satomura
Shinji
S
Aoyagi
Yutaka
Y
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000175:diagnosis* / Q000401:mortality / Q000473:pathology; D019075:Electrophoresis, Capillary; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008113:Liver Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D037121:Plant Lectins; D011379:Prognosis; D012372:ROC Curve; D012680:Sensitivity and Specificity; D000509:alpha-Fetoproteins / Q000032:analysis*
C097353:AFP protein, human; D037121:Plant Lectins; D000509:alpha-Fetoproteins
J Hepatol. 1999 Jan;30(1):125-30
9927159
Am J Gastroenterol. 1999 Oct;94(10):3028-33
10520864
Cancer. 1988 Feb 15;61(4):769-74
2448024
J Clin Gastroenterol. 2001 Mar;32(3):240-4
11246354
Anal Biochem. 2009 May 15;388(2):306-11
19250915
Am J Gastroenterol. 1998 Dec;93(12):2452-6
9860408
Cancer Res. 1993 Nov 15;53(22):5419-23
7693340
J Gastroenterol Hepatol. 2001 Dec;16(12):1378-83
11851836
J Gastroenterol. 2003;38(3):207-15
12673442
Cancer. 1998 Nov 15;83(10):2076-82
9827711
Am J Clin Pathol. 1999 Jun;111(6):811-6
10361518
Electrophoresis. 2008 Apr;29(7):1399-406
18384019
J Gastroenterol. 2007 Dec;42(12):962-8
18085353
Hepatology. 2006 Dec;44(6):1518-27
17133456
Cancer. 1970 May;25(5):1091-8
5443731
Anal Chem. 1998 Mar 1;70(5):954-7
9511471
Hepatol Res. 2007 Nov;37(11):914-22
17610501
Hepatology. 1993 Jan;17(1):50-2
7678576
Cancer Res. 1968 Jul;28(7):1344-50
4174340