Summary of the questionnaire on current practices for plasma
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
Abbreviations: EGFR, epidermal growth factor receptor; TKI, tyrosine kinase inhibitor.
© Ann Lab Med