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Elecsys® PIVKA-II

pivka-ii

A sensitive and accurate tool for use as an aid in the diagnosis of HCC

What are the current limitations in current HCC surveillance methods?1

Only 63% Sensitivity2

 

of Ultrasound + AFP

in detecting early stage HCC


37%

will be missed


 
ultrasound
  • Poor performance in patients with fibrotic changes and fatty infiltration of the liver
  • Difficult to perform in obese patients
  • Difficult to detect small lesions (< 2cm)
  • Limited capacity in public hospitals and rural settings
  • Operator variability
ultrasound

AFP is not specific for HCC. It can be elevated (false positive) in the following conditions:

  • Cirrhosis
  • Active hepatitis
  • Other types of tumours

AFP can be normal (false negative) in the following conditions:

  • Certain HCC patients have normal AFP throughout the entire disease course
  • Small size HCC (tumour < 2 cm)
 

What is PIVKA-II?

elecsys-pivka-ii

elecsys-pivka-ii

PIVKA-II detects HCC with a higher sensitivity vs AFP5

 


Comparison between PIVKA-II and AFP

  All HCC Early Stage HCC* Late Stage HCC†
Marker PIVKA-II AFP PIVKA-II AFP PIVKA-II AFP
Sensitivity
(95% CI)

86.90%

(80.8%, 91.6%)

51.80%

(44%, 59.5%)

77.90%

(67%, 86.6%)

36.40%

(25.7%, 48.1%)

94.50%

(87.6%, 98.2%)

64.80%

(54.1%, 74.6%)

Specificity
(95% CI)

83.70%

(77.9%, 88.4%)

98.10%

(95.1%, 99.5%)

83.70%

(77.9%, 88.4%)

98.10%

(95.1%, 99.5%)

83.70%

(77.9%, 88.4%)

98.10%

(95.1%, 99.5%)
ROC AUC§ 90.80%
(87.5%−94.1%)		 88%
(84.5%−91.5%		 84.70%
(78.7%−90.8%)		 84.50%
(79.3%−89.7%)		 95.50%
(93.2%−98.7%)		 90.90%
(86.8%−95.1%)
  All HCC
Marker PIVKA-II AFP
Sensitivity
(95% CI)
86.90%

(80.8%, 91.6%)		 51.80%
(44%, 59.5%)
Specificity
(95% CI)		 83.70%
(77.9%, 88.4%)		 98.10%
(95.1%, 99.5%)
ROC AUC§ 90.80%
(87.5%−94.1%)		 88%
(84.5%−91.5%)


  Early Stage HCC*
Marker PIVKA-II AFP
Sensitivity
(95% CI)
77.90%

(67%, 86.6%)		 36.40%
(25.7%, 48.1%)
Specificity
(95% CI)		 83.70%
(77.9%, 88.4%)
 98.10%
(95.1%, 99.5%)
ROC AUC§ 84.70%
(78.7%−90.8%)
 84.50%
(79.3%−89.7%)


  Late Stage HCC†
Marker PIVKA-II AFP
Sensitivity
(95% CI)
94.50%

(87.6%, 98.2%)
 64.80%
(54.1%, 74.6%)
Specificity
(95% CI)		 83.70%
(77.9%, 88.4%)
 98.10%
(95.1%, 99.5%)
ROC AUC§ 95.50%
(93.2%−98.7%)
 90.90%
(86.8%−95.1%)

 

At the cut-off of 28.4 ng/mL Elecsys PIVKA-II shows a higher sensitivity

vs AFP surveillance cut-off of 20 ng/mL5,6

*BCLC stages 0, A † BCLC stages B,C,D ‡ Applies to sensitivity and specificity only § Area under the Curve

 
 
 

What is the best recommended approach for better and more accurate diagnosis?

 

The combination of PIVKA-II and AFP
has markedly better sensitivity for detecting HCC vs AFP alone7

 

Comparison between PIVKA-II + AFP and AFP

 

  AFP AFP + PIVKA-II
Sensitivity
(All HCC)		 51.8%

91.7%
Sensitivity
(Early Stage HCC)*		 36.4%

87.0%
Specificity
(Late Stage HCC)†		 64.8% 95.6%
Specificity 98.1% 82.2%
AFP cut-off value: 20 ng/mL; PIVKA-II cut-off value: 28.4 ng/mL
* BCLC stages 0, A; † BCLC stages B,C,D


  AFP AFP + PIVKA-II
Sensitivity
(All HCC)		 51.8%

91.7%
Sensitivity
(Early Stage HCC)*		 36.4%

87.0%
Specificity
(Late Stage HCC)†		 64.8% 95.6%
Specificity 98.1% 82.2%
AFP cut-off value: 20 ng/mL; PIVKA-II cut-off value: 28.4 ng/mL
* BCLC stages 0, A; † BCLC stages B,C,D
 

By using the combination of PIVKA-II, AFP and US, we can improves the sensitivity for detection of HCC

asset 7
By using the combination of PIVKA-II, AFP and US, we can improves the sensitivity for detection of HCC
 
PIVKA-II concentration reliably shows gradual
HCC disease progression and clear differentiation5,7


Range of PIVKA-II distribution

PIVKA-II concentration and disease etiology

 
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Useful Resources

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    References

     

    1. Simmons,O.etal.(2017),Predictorsofadequateultrasoundqualityforhepatocellularcarcinomasurveillanceinpatientswithcirrhosis.AlimentPharmacolTher,45:169-177.doi:10.1111/apt.13841; EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma., Journal of Hepatology, Volume 69, Issue 1, 2018, Pages 182-236, ISSN 0168-8278; Sherman M. Limitations of screening for hepatocellular carcinoma. Hepat Oncol. 2014;1(2):161–163. doi:10.2217/hep.13.22
    2. Singal, A.G.,et al.. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018 May;154(6):1706-1718.e1.
    3. Liebmann, H.A. et al. (1984). Des-gamma-carboxy (abnormal) prothrombin as a serum marker of primary hepatocellular carcinoma. N Eng J Med 310, 1427-1431.
    4. Ono, M. et al. (1990). Measurement of immunoreactive prothrombin precursor and vitamin-K-dependent gamma-carboxylation in human hepatocellular carcinoma tissues: Decreased carboxylation of prothrombin precursor as a cause of des-gamma-carboxy prothrombin synthesis. Tumour Biol 11, 319-326.
    5. Chan, H. L. Y., Vogel, A., Berg, T., De Toni, E. N., Kudo, M., Trojan, J., ... & Piratvisuth, T. (2020, November). ELECSYS PIVKA-II AND ELECSYS AFP ASSAYS DEMONSTRATE GOOD CLINICAL PERFORMANCE FOR HEPATOCELLULAR CARCINOMA (HCC) DIAGNOSIS ACROSS DIFFERENT DISEASE STAGES AND ETIOLOGIES. In The Liver Meeting Digital Experience™. AASLD.
    6. Chang TS et al. Am J Gastroenterol 2015;110:836–844
    7. Roche CE method sheet PIVKA-II 2020 (Roche studies No. RD002542 and RD002543)

    MAP-2023-JUL-002