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Elecsys® Anti-p53

Immunoassay for the in vitro quantitative determination of anti-p53 autoantibodies in human serum and plasma.

Elecsys Reagent Pack
Immunoassay for the in vitro quantitative determination of anti-p53 autoantibodies in human serum and plasma.1,2

The anti-p53 assay is used to aid in the diagnosis of esophageal cancer, colorectal cancer and breast cancer in conjunction with other tests.1,2

Mutation of p53 is present in half of the solid tumors.3 It is the most common genetic change identified so far in human cancers.4 When a mutation in p53 or other mutations lead to an accumulation of p53 in the cytoplasm, proteolytic fragments thereof may be presented on the cell surface or otherwise released, resulting in the formation of anti-p53 autoantibodies.3

Early appearance of anti-p53 antibodies during tumor development may have potential for detecting malignant transformation, especially in patients with pre-neoplastic disease.5

Anti-p53 antibodies have a very high specificity of 96% to up to near 100%3,5 but a low sensitivity for cancer.

The registrational data of Elecsys® Anti-p53 assay as aid in diagnosis of esophageal cancer, colorectal cancer and breast cancer in conjunction with other tests have been provided by Roche Multi Centre Evaluation study for clinical performance.

The Sample Collection study was performed in an observational case-control study design with prospective and retrospective samples with a total of 676 patients and 400 controls.10

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Elecsys Anti-p53
Esophageal Cancer

Several studies have shown that serum anti-p53 antibodies (s-p53-Abs) can be detected independently from conventional tumor markers and may be used in diagnosis in patients with esophageal cancers.6

Combining anti-p53 with other tumor markers may improve the rate of cancer detection. The diagnostic sensitivity of conventional tumor markers may be enhanced with the addition of s-p53-Abs, without a decrease in specificity, suggesting a promising role for s-p53-Abs as part of a panel of tumor markers.6

The data displayed below represent the measurements obtain in the Roche Multi Center Evaluation for Elecsys® Anti-p53 CE registration.10

The esophageal cancer cohort included 158 patients and 124 control. In this cohort, beside Elecsys® Anti-p53, the additional 3 parameters have been measured:

  • Elecsys® CEA - displayed here
  • Elecsys® CYFRA
  • Elecsys® SCC - displayed here
Esophageal Cancer graph

Bar chart of the positive rate in esophageal disease cohort benign controls, cancer cases and UICC stage subgroups (Anti-p53, CEA. CEA + Anti-p53). In controls the non-inferiority test is performed to compare the specificity of the combined marker to the reference marker Significance levels are shown as: * p < 0.05, ** p< 0.01, *** p < 0.001, NS not significant, NA not available 10

Esophageal disease cohort graph

Bar chart of the positive rate in esophageal disease cohort benign controls, cancer cases and UICC stage subgroups (Anti-p53, SCC. SCC + Anti-p53). In controls the non-inferiority test is performed to compare the specificity of the combined marker to the reference marker. Significance levels are shown as: * p < 0.05, ** p< 0.01, *** p < 0.001, NS not significant, NA not available. 10

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The Clinical results about Elecsys® Anti-p53 + Elecsys® SCC show significant improvement overall in sensitivity over SCC alone.

   CEA SCC Anti-p53
 CEA + Anti-p53 SCC + Anti-p53
Cut-off 5 ng/mL
 2.5 ng/mL 
 0.05 μg/mL    
Sensitivity (CI) 10.76 (6.39 - 16.67) 48.1 (40.1 – 56.18) 17.09 (11.57 – 23.88)
 25.95 (19.31 - 33.51) 54.43 (46.33 – 62.36)
Specificity (CI) 95.97 (90.84 - 98.68) 94.31 (88.63 – 97.68)
 96.77 (91.95 – 99.11)
 92.74 (86.67 - 96.63) 91.06 (84.56 – 95.45)
Colorectal cancer

Colorectal cancer (CRC) is the third most frequent cause for cancer-related deaths in the world. Its development is associated with series of defined genetic alterations that promote the transformation of normal epithelial mucosa into carcinoma, including aberrations in APC, K-Ras, and p53.7

p53 was found to be mutated in about 40 percent of CRC cases. Indeed, it is well-accepted that mutant p53 plays an important role in CRC development. Accordingly, we previously found that mutant p53 promotes inflammation-associated colorectal cancer.7

The data displayed below represent the measurements obtain in the Roche Multi Center Evaluation for Elecsys® Anti-p53 CE registration.10

The colorectal cancer cohort included 218 patients and 189 control. In this cohort, beside Elecsys® Anti-p53, the additional parameter has been measured:

  • Elecsys® CEA
Colorectal disease cohort graph

Bar chart of the positive rate in esophageal disease cohort benign controls, cancer cases and UICC stage subgroups (Anti-p53, SCC. SCC + Anti-p53). In controls the non-inferiority test is performed to compare the specificity of the combined marker to the reference marker. Significance levels are shown as: * p < 0.05, ** p< 0.01, *** p < 0.001, NS not significant, NA not available.10

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The Clinical results about Elecsys® Anti-p53 + Elecsys® CEA show significant improvement overall in sensitivity over CEA alone.

   CEA Anti-p53 CEA + Anti-p53
Cut-off 5 ng/mL 0.05 μg/mL  
Sensitivity (CI) 40.83 (34.24 – 47.67) 20.64 (15.47 – 26.63) 51.38 (44.53 – 58.18)
Specificity (CI) 89.42 (84.13 – 93.42) 97.35 (93.93 – 99.14) 87.83 (82.3 – 92.13)
Breast Cancer

Breast cancer was the first human tumor in which anti-p53 antibody was identified, after which it was detected in various malignancies. In patients with breast cancer, a positive rate ranging from 1% to 48% has been reported for anti-p53 antibodies.8

p53 mutation remains the most common genetic change identified in human neoplasia.9 In breast cancer, p53 mutation is associated with more aggressive disease and worse overall survival.9

Clinical results about Elecsys® Anti-p53 + Elecsys® SCC shows significant improvement overall in sensitivity over CA 15-3 alone.

The data displayed below represent the measurements obtain in the Roche Multi Center Evaluation for Elecsys® Anti-p53 CE registration.10

The colorectal cancer cohort included 300 patients and 87 control. In this cohort, beside Elecsys® Anti-p53, the additional  parameter has been measured:

  • Elecsys® CA 15-3
Breast Cancer graph

Bar chart of the positive rate in breast disease cohort benign controls, cancer cases and UICC stage subgroups (Anti-p53, CA 15-3, CA 15-3 + Anti-p53). Significance levels are shown as: * p < 0.05, ** p < 0.01, *** p < 0.001, NS not significant, NA not available.10

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The Clinical results about Elecsys® Anti-p53 + Elecsys® SCC show significant improvement overall in sensitivity over CA 15-3 alone.

   CA 15-3 Anti-p53 CA 15-3 + Anti-p53
Cut-off 25 ng/mL 0.05 μg/mL  
Sensitivity (CI) 24 (19.28 – 29.24) 4 (2.08 – 6.88) 26.67 (21.75 – 32.05)
Specificity (CI) 88.51 (79.88 – 94.35) 96.55 (90.25 – 99.28) 87.36 (78.5 – 93.52)

Related information

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    References

    1. Elecsys® Anti-p53 Method Sheet for cobas e411, cobas e601 & cobas e602
    2. Elecsys® Anti-p53 Method Sheet for cobas e402, cobas e 801
    3. Suppiah A, Greenman J. Clinical utility of anti-p53 auto-antibody: systematic review and focus on colorectal cancer. World J Gastroenterol 2013;19(29):4651-4670
    4. Lenner P, Wiklund F, Emdin SO, et al. Serum antibodies against p53 in relation to cancer risk and prognosis in breast cancer. Br J Cancer 1999;79:927-932.
    5. Soussi T. p53 antibodies in the sera of patients with various types of cancer: a review. Cancer Res 2000;60(7):1777-1788.
    6. New Assay System Elecsys® Anti-p53 to Detect Serum Anti-p53 Antibodies in Esophageal Cancer Patients and Colorectal Cancer Patients: Multi-institutional Study. Yajima et. Al. Annn Surg Oncol (2021) 28:4007-4015
    7. Mutant p53 gain of function underlies high expression levels of colorectal cancer stem cells markers  Solomon, H., Dinowitz, N., Pateras, I.S. et al. . Oncogene 37, 1669–1684 (2018)
    8. Serum p53 antibody in breast cancer. Shinya Yamamoto et al. Cancer Biomarkers 14 (2014) 203–206 203. DOI 10.3233/CBM-140396
    9. Review The p53 pathway in breast cancer. Milena Gasco et al. Breast Cancer Res 2002, 4:70-76
    10. Roche MCE studies No. RD003689 and RD003714

    Elecsys® Anti-p531,2

    • Systems

      cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
      cobas e 801 analytical unit, cobas e 402 analytical unit

    • Testing Time

      18 minutes

    • Test principle

      One-step double antigen sandwich assay

    • Calibration

      2-point

    • Sample material

      Serum collected using standard sampling tubes or tubes containing separating gel; Li-heparin, K2 EDTA and K3-EDTA plasma

    • Sample volume

      20 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
      12 μL cobas e 801 analytical unit, cobas e 402 analytical unit

    • Onboard stability

      8 weeks on cobas e 411 analyzer, cobas e 601 / 602 modules
      16 weeks on cobas e 801, cobas e 402 analytical units

    • Measuring range

      0.020 – 100 µg/mL

    • Limit of Detection (LoD)

      ≤ 0.04 µg/mL

    • Limit of Quantitation (LoQ)

      ≤ 0.10 µg/mL

    • Intermediate precision in positive samples*

      cobas e 411 analyzer: CV 4.5 – 6.9 %
      cobas e 601 / cobas e 602 modules: CV 2.9 – 5.9 %
      cobas e 801, cobas e 402 analytical units: CV 1.5 – 3.2 %

    • Repeatability in positive samples*

      cobas e 411 analyzer: CV 1.2 – 4.8 %
      cobas e 601 / cobas e 602 modules: CV 0.9 – 2.7 %
      cobas e 801, cobas e 402 analytical units: CV 0.7 – 2.5 %