Technical Evaluation of the COBAS EGFR Semiquantitative Index (SQI) for Plasma cfDNA Testing in NSCLC Patients with EGFR Exon 19 Deletions
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients and Plasma Samples
2.2. Extraction of cfDNA from Plasma Samples
2.3. Molecular Characterization of EGFR in cfDNA from Plasma
2.4. Statistical Analysis
3. Results
3.1. Study Cohort
3.2. Agreement between Cobas® EGFR Test and the ddPCRTM EGFR Test
3.3. The SQI from Cobas® EGFR Test Correlates with the VAF and the Number of Mutated Copies/mL from ddPCRTM EGFR Test
3.4. Example of Correlation between SQI and VAF and SQI and Mutated Copies/mL in a Patient with Longitudinal Follow-Up
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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ID | Age | Sex | EGFR Status by Tissue Analyses | Number of Samples | Baseline Samples | Follow-Up Samples | Mutation Included in Cobas EGFR Test | Mutation Included in ddPCR Assay |
---|---|---|---|---|---|---|---|---|
ID01 | 91 | F | NA | 1 | 1 | 0 | NA | NA |
ID02 | 73 | M | c.2235_2249del15 | 1 | 1 | 0 | Yes | Yes |
ID03 | 53 | M | c.2240_2251del12 | 4 | 1 | 3 | Yes | No |
ID04 | 40 | M | c.2236_2250del15 | 5 | 1 | 4 | Yes | Yes |
ID05 | 56 | F | NA | 3 | 1 | 2 | NA | NA |
ID06 | 70 | M | NA | 2 | 1 | 1 | NA | NA |
ID07 | 77 | M | NA | 3 | 1 | 2 | NA | NA |
ID08 | 87 | M | c.2236_2250del15 | 2 | 1 | 1 | Yes | Yes |
ID09 | 72 | F | c.2235_2249del15 | 6 | 1 | 5 | Yes | Yes |
ID10 | 87 | F | c.2236_2250del15 | 2 | 1 | 1 | Yes | Yes |
ID11 | 70 | F | NA | 1 | 1 | 0 | NA | NA |
ID12 | 79 | F | NA | 3 | 1 | 2 | NA | NA |
ID13 | 61 | F | c.2235_2249del15 | 2 | 0 | 2 | Yes | Yes |
ID14 | 81 | F | NA | 4 | 0 | 4 | NA | NA |
ID15 | 69 | F | c.2240_2257del18 | 20 | 0 | 20 | Yes | Yes |
ID16 | 56 | F | c.2337_2255insT | 2 | 0 | 2 | Yes | No |
ID17 | 74 | F | c.2235_2249del15 | 1 | 0 | 1 | Yes | Yes |
ID18 | 83 | F | NA | 8 | 0 | 8 | NA | NA |
ID19 | 67 | F | NA | 2 | 0 | 2 | NA | NA |
ID20 | 67 | M | NA | 12 | 0 | 12 | NA | NA |
ID21 | 80 | F | c.2235_2249del15 | 1 | 0 | 1 | Yes | Yes |
ID22 | 45 | F | c.2235_2249del15 | 11 | 0 | 11 | Yes | Yes |
ID23 | 49 | F | c.2236_2250del15 | 5 | 0 | 5 | Yes | Yes |
ID24 | 58 | F | c.2240_2254del15 | 2 | 0 | 2 | Yes | Yes |
ID25 | 61 | F | c.2236_2250del15 | 15 | 0 | 15 | Yes | Yes |
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González de Aledo-Castillo, J.M.; Serhir-Sgheiri, S.; Calbet-Llopart, N.; Arcocha, A.; Jares, P.; Reguart, N.; Puig-Butillé, J.A. Technical Evaluation of the COBAS EGFR Semiquantitative Index (SQI) for Plasma cfDNA Testing in NSCLC Patients with EGFR Exon 19 Deletions. Diagnostics 2021, 11, 1319. https://doi.org/10.3390/diagnostics11081319
González de Aledo-Castillo JM, Serhir-Sgheiri S, Calbet-Llopart N, Arcocha A, Jares P, Reguart N, Puig-Butillé JA. Technical Evaluation of the COBAS EGFR Semiquantitative Index (SQI) for Plasma cfDNA Testing in NSCLC Patients with EGFR Exon 19 Deletions. Diagnostics. 2021; 11(8):1319. https://doi.org/10.3390/diagnostics11081319
Chicago/Turabian StyleGonzález de Aledo-Castillo, José Manuel, Samira Serhir-Sgheiri, Neus Calbet-Llopart, Ainara Arcocha, Pedro Jares, Noemí Reguart, and Joan Antón Puig-Butillé. 2021. "Technical Evaluation of the COBAS EGFR Semiquantitative Index (SQI) for Plasma cfDNA Testing in NSCLC Patients with EGFR Exon 19 Deletions" Diagnostics 11, no. 8: 1319. https://doi.org/10.3390/diagnostics11081319