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Table. 1.

Summary of the questionnaire on current practices for plasma EGFR variant testing in 19 Korean clinical laboratories

Category Questions Answers N (%) of laboratories
1. Test place, platform, and turn-around time 1.1. Is the test conducted in-house of the institution or outsourced to an external laboratory? a. In-house 12 (63.2)
b. External laboratory 7 (36.8)
1.2. What does the test platform use? a. Cobas EGFR Mutation Test v2 17 (89.5)
b. PANAMutyper R EGFR 0
c. Both (Cobas and PANAMutyper) 1 (5.3)
d. No response 1 (5.3)
1.3. How long does it take to report the test result after a sample is received? a. Within three days 3 (15.8)
b. Within seven days 13 (68.4)
c. Within 10 days 2 (10.5)
d. No response 1 (5.3)
2. Results of testing 2.1. What is the average monthly EGFR T790M variant-positive rate (No. of EGFR T790M variant-positive cases/No. of total tested cases)? a. <10% 3 (15.8)
b. ≥10 – <20% 8 (42.1)
c. ≥20 – <30% 2 (10.5)
d. ≥30 – <40% 1 (5.3)
e. No response 5 (26.3)
2.2. What is the optimal EGFR T790M variant-positive rate you expect? a. <10% 1 (5.3)
b. ≥10 – <20% 8 (42.1)
c. ≥20 – <30% 3 (15.8)
d. ≥30 – <40% 1 (5.3)
e. ≥40 – <50% 2 (10.5)
f. No response 4 (21.1)
2.3. Why do you think the actual EGFR T790M variant-positive rate is below expectations?* a. False-negatives due to low tumor burden 8 (42.1)
b. False-negatives due to limited sensitivity of the test 4 (21.1)
c. Inadequacy of sample processing (pre-analytical process) 5 (26.3)
d. Limited number and timing of the test due to criteria of health insurance 4 (21.1)
e. Small number of tests 4 (21.1)
f. Other 4 (21.1)
g. No response 5 (26.3)
3. External quality assessment 3.1. Have you ever participated in external quality assessment programs for plasma EGFR variant testing? a. Yes 9 (47.4)
b. No 8 (42.1)
c. No response 2 (10.5)

*Duplicate answers allowed; This result is the situation at the time of the survey between December 2018 to January 2019; currently, all laboratories that conduct plasma EGFR variant testing participate in external quality assessment programs.

Abbreviations: EGFR, epidermal growth factor receptor; TKI, tyrosine kinase inhibitor.

Ann Lab Med 2022;42:141~149 https://doi.org/10.3343/alm.2022.42.2.141

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