ANALYTICAL SENSITIVITY-THRESHOLD VALUE

The Detection Threshold for the assay is 0,75 ng/mL.

The assay sensitivity for undiluted clinical samples corresponds to 1,5 ng/mL

Because the serum or plasma samples are instructed to be diluted at two-fold (1:2) before starting the assay.

 

ASSAY RANGE

For anti-Cetuximab antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99 %) linear from 0 to 30 ng/mL.

 

ASSAY PRECISION

Intra-assay CV:

Mean	CV (%)
30	<10
10	<10
3	<10

Inter-assay CV: <10%.

 

ASSAY RECOVERY

Recovery rate was found to be 85-115% using native serum and plasma samples spiked with exogenous Anti Drug Antibody (ADA) positive samples.

 

AUTOMATION

The ImmunoGuide ADA ELISA is suitable also for being used by an automated ELISA processor.

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2. Lupini L, Bassi C, Mlcochova J, Musa G, Russo M, Vychytilova-Faltejskova P, Svoboda M, Sabbioni S, Nemecek R, Slaby O, Negrini M. Prediction of response to anti-EGFR antibody-based therapies by multigene sequencing in colorectal cancer patients. BMC Cancer. 2015 Oct 27;15:808. doi: 10.1186/s12885-015-1752-5.

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4. Zhu AX, Stuart K, Blaszkowsky LS, Muzikansky A, Reitberg DP, Clark JW, Enzinger PC, Bhargava P, Meyerhardt JA, Horgan K, Fuchs CS, Ryan DP. Phase 2 study of cetuximab in patients with advanced hepatocellular carcinoma. Cancer. 2007;110(3):581-9.

5. Tan AR, Moore DF, Hidalgo M, Doroshow JH, Poplin EA, Goodin S, Mauro D, Rubin EH. Pharmacokinetics of cetuximab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors. Clin Cancer Res. 2006;12(21):6517-22.

6. Lu X, Chen X, Sun J, Gao P, Song Y, Huang X, Luo Y, Chen P, Wang Z. Polymorphism in epidermal growth factor is related to clinical outcomes of metastatic colorectal cancer patients treated with cetuximab: a systematic review and meta-analysis. Int J Clin Exp Med. 2015;8(7):10929-37.

7. Boeckx C, Blockx L, de Beeck KO, Limame R, Camp GV, Peeters M, Vermorken JB, Specenier P, Wouters A, Baay M, Lardon F. Establishment and characterization of cetuximab resistant head and neck squamous cell carcinoma cell lines: focus on the contribution of the AP-1 transcription factor. Am J Cancer Res. 2015;5(6):1921-38.

8. Kurokawa M, Watanabe Nemoto M, Harada R, Kobayashi H, Horikoshi T, Kanazawa A, Togasaki G, Abe Y, Chazono H, Hanazawa T, Okamoto Y, Uno T. Initial experience of radiotherapy plus cetuximab for Japanese head and neck cancer patients. J Radiat Res. 2015;56(5):849-55.

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