Development of des-γ-carboxy prothrombin (DCP) measuring reagent using the LiBASys clinical analyzer

Yamaguchi, Isao; Nakamura, Kenji; Kitano, Hiromichi; Masuda, Yoshie; Kanke, Futoshi; Kobatake, Shinzo; Satomura, Shinji

doi:10.1515/cclm.2008.078

Cited by 6 publications

(5 citation statements)

References 26 publications

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“…The recent development of highly sensitive AFP-L3 using an automated microfluidic based assay has made the isoform even more sensitive and specific (13,34). Because AFP, high-sensitivity AFP-L3, and DCP can now be measured on a single platform (44), the risk figure could be routinely reported. AFP-L3 and DCP have been approved by the Food and Drug Administration (FDA) in the United States and European Medicines Agency (EMEA) in Europe for the diagnosis of hepatocellular carcinoma.…”

Section: Discussionmentioning

confidence: 99%

The Detection of Hepatocellular Carcinoma Using a Prospectively Developed and Validated Model Based on Serological Biomarkers

Johnson¹,

Pirrie

Cox³

et al. 2014

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Background: Hepatocellular carcinoma is a common complication of chronic liver disease (CLD), and is conventionally diagnosed by radiological means. We aimed to build a statistical model that could determine the risk of hepatocellular carcinoma in individual patients with CLD using objective measures, particularly serological tumor markers.Methods: A total of 670 patients with either CLD alone or hepatocellular carcinoma were recruited from a single UK center into a case-control study. Sera were collected prospectively and specifically for this study. A logistic regression analysis was used to determine independent factors associated with hepatocellular carcinoma and a model built and assessed in terms of sensitivity, specificity, and proportion of correct diagnoses.Results: The final model involving gender, age, AFP-L3, a fetoprotein (AFP), and des-carboxy-prothrombin ("GALAD") was developed in a "discovery" data set and validated in independent data sets both from the same institution and from an external institution. When optimized for sensitivity and specificity, the model gave values of more than 0.88 irrespective of the disease stage.Conclusions: The presence of hepatocellular carcinoma can be detected in patients with CLD on the basis of a model involving objective clinical and serological factors. It is now necessary to test the model's performance in a prospective manner and in a routine clinical practice setting, to determine if it may replace or, more likely, enhance current radiological approaches.Impact: Our data provide evidence that an entirely objective serum biomarker-based model may facilitate the detection and diagnosis of hepatocellular carcinoma and form the basis for a prospective study comparing this approach with the standard radiological approaches. Cancer Epidemiol Biomarkers Prev; 23(1); 144-53. Ó2013 AACR.

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Section: Discussionmentioning

confidence: 99%

The Detection of Hepatocellular Carcinoma Using a Prospectively Developed and Validated Model Based on Serological Biomarkers

Johnson¹,

Pirrie

Cox³

et al. 2014

Cancer Epidemiology, Biomarkers &Amp; Prevention

Self Cite

259

244

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“…in 1984, several immunoassays have been developed by the manufacturers. The manual ELISA PIVKA II Eitest is the reference assay for the automated tests which use a liquid binding assay on the LiBASys (Wako), electrochemiluminescence as the Picolumi test and chemiluminescence on the Lumipulse (Fujirebio) and Tosoh analyzers. These assays use a monoclonal antibody MU‐3 reacting with an epitope located within the amino acid residues 17‐27 in the γ‐carboxyglutamic domain.…”

Section: Discussionmentioning

confidence: 99%

Diagnostic accuracy of des‐gamma‐carboxy prothrombin for hepatocellular carcinoma in a French cohort using the Lumipulse^® G600 analyzer

Sultanik

Ginguay

Vandame

et al. 2016

Journal of Viral Hepatitis

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The increasing incidence of hepatocellular carcinoma (HCC) in Western countries requests reliable tumour markers for preclinical diagnosis. We evaluated the diagnostic accuracy of des-gamma-carboxy prothrombin (DCP), in comparison with alpha-fetoprotein (AFP) in a French cohort using a new analyser. One hundred and sixty-two patients with virus-related cirrhosis (46 HCC patients and 116 controls) were recruited in this retrospective proof-of-concept study. DCP was measured on new Lumipulse G600 analyzer and AFP on usual Cobas e602 analyzer in serum samples that were collected at the time of HCC diagnosis for HCC patients or during follow-up for controls. DCP and AFP levels were higher in HCC patients. The area under receiver operating characteristic curve was larger for DCP than for AFP (0.89 vs 0.77, P=.03). At the cut-off value of 128 mAU/mL, sensitivity and specificity for DCP were 74% and 92%. At the cut-off value of 20 μg/L, sensitivity and specificity for AFP were 63% and 82%. NRI for the association of "AFP+DCP" were 101%, P<.0001, and 23%, P=.03, compared to "AFP" or "DCP" alone, respectively. We conclude that DCP outperformed AFP for the detection of HCC.

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“…All aliquots were analyzed in a blinded fashion at the laboratory of Wako Chemicals GmbH ® (Neuss, Germany). Serum concentrations of AFP and DCP were determined using the Wako LiBASys ® clinical auto-analyzer by a liquid-phase binding assay [17]. Interassay coefficient of variation for total AFP concentration ranges from 2.6 to 4.6%.…”

Section: Methodsmentioning

confidence: 99%

“…Interassay coefficient of variation for DCP concentration ranges from 2.2 to 6.5%. The analytical limit of detection is 0.5 ng/ml, and the assay is linear up to 500 ng/ml DCP concentration [17]. For comparison with other studies, the conversion from mAU/ml to ng/ml can be calculated by a conversion factor of 0.019 (1 mAU/ml = 0.019 ng/ml) [17].…”

Section: Methodsmentioning

confidence: 99%

A Combination of α-Fetoprotein and Des-γ-Carboxy Prothrombin Is Superior in Detection of Hepatocellular Carcinoma

Ertle¹,

et al. 2013

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Background and Aim: The incidence of hepatocellular carcinoma (HCC) is increasing in western countries. Despite its low sensitivity, the diagnosis of HCC still depends on detection of α-fetoprotein (AFP). Therefore, the aim of this study was to evaluate the combined analysis of AFP and des-γ-carboxy prothrombin (DCP) in a European cohort. Methods: We performed a single-center study (164 HCC/422 controls), in which the serum concentrations of AFP and DCP were determined. Results: AFP and DCP were elevated in HCC patients compared to controls (p < 0.0001). By combination of AFP and DCP, the sensitivity was improved from 28.7% for AFP (cutoff 400 ng/ml; AFP at cutoff 10 ng/ml: 54.9%) to 78.0% using cutoffs of 10 ng/ml for AFP and 5 ng/ml for DCP (DCP alone, cutoff 5 ng/ml: 63.4%). Among early-stage patients, the sensitivity increased from 20% for AFP (cutoff 400 ng/ml; AFP at cutoff 10 ng/ml: 38%) to 55% in combination (DCP alone, cutoff 5 ng/ml: 47%). The area under the curve (AUC) for AFP and DCP was similar (AFP: 0.88; DCP: 0.87; combined: 0.91). Among non-cirrhotic patients, DCP (AUC: 0.93) showed a better performance than AFP (AUC: 0.84). Especially patients with non-alcoholic steatohepatitis had a high percentage of DCP-positive tumors. Conclusion: The data suggest that AFP alone is not sufficient for the serological diagnosis of HCC in European patients, while a combination of AFP and DCP can increase the sensitivity even in early-stage patients.

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Development of des-γ-carboxy prothrombin (DCP) measuring reagent using the LiBASys clinical analyzer

Abstract: The LiBASys clinical analyzer made possible measurement of the complementary tumor markers, HCC, total AFP, AFP-L3 and DCP.

Cited by 6 publications

References 26 publications

The Detection of Hepatocellular Carcinoma Using a Prospectively Developed and Validated Model Based on Serological Biomarkers

The Detection of Hepatocellular Carcinoma Using a Prospectively Developed and Validated Model Based on Serological Biomarkers

Diagnostic accuracy of des‐gamma‐carboxy prothrombin for hepatocellular carcinoma in a French cohort using the Lumipulse^® G600 analyzer

A Combination of α-Fetoprotein and Des-γ-Carboxy Prothrombin Is Superior in Detection of Hepatocellular Carcinoma

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Development of des-γ-carboxy prothrombin (DCP) measuring reagent using the LiBASys clinical analyzer

Abstract: The LiBASys clinical analyzer made possible measurement of the complementary tumor markers, HCC, total AFP, AFP-L3 and DCP.

Cited by 6 publications

References 26 publications

The Detection of Hepatocellular Carcinoma Using a Prospectively Developed and Validated Model Based on Serological Biomarkers

The Detection of Hepatocellular Carcinoma Using a Prospectively Developed and Validated Model Based on Serological Biomarkers

Diagnostic accuracy of des‐gamma‐carboxy prothrombin for hepatocellular carcinoma in a French cohort using the Lumipulse® G600 analyzer

A Combination of α-Fetoprotein and Des-&#947;-Carboxy Prothrombin Is Superior in Detection of Hepatocellular Carcinoma

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Diagnostic accuracy of des‐gamma‐carboxy prothrombin for hepatocellular carcinoma in a French cohort using the Lumipulse^® G600 analyzer

A Combination of α-Fetoprotein and Des-γ-Carboxy Prothrombin Is Superior in Detection of Hepatocellular Carcinoma