Question 1
Commonly used metrics and quality control parameters used to assess run performance for NGS wet bench process documentation include:
A. Percentage of reads mapping to the target region
B. Fraction of bases meeting specified quality and coverage thresholds
C. Average coverage per base
+++++++++++++++++++++++++++++++++++++
Answer 1
All of the above.
See Aziz et al. (College of American Pathologists’ Laboratory Standards for Next-Generation Sequencing Clinical Tests APLM 2014)
+++++++++++++++++++++++++++++++++++++
Question 2
Essential performance characteristics that need to be determined during internal validation include:
A. Analytic sensitivity
B. Analytic specificity
C. Accuracy
D. Precision
E. Limit of detection
+++++++++++++++++++++++++++++++++++++
Answer 2
All of the above.
See Aziz et al. (College of American Pathologists’ Laboratory Standards for Next-Generation Sequencing Clinical Tests APLM 2014)
+++++++++++++++++++++++++++++++++++++
Question 3
According to the framework proposed by the ACCE, genetic tests should be evaluated on which of the following criteria:
A. Analytical validity
B. Clinical validity
C. Clinical utility
D. Ethical, legal and social issues
+++++++++++++++++++++++++++++++++++++
Answer 3
All of the above.
See Easton et al. (NEJM 2015)
+++++++++++++++++++++++++++++++++++++
Question 4
In vitro diagnostics that have gone through and passed a 510(k) trial are considered FDA-approved - True/False
+++++++++++++++++++++++++++++++++++++
Answer 4
False. FDA-cleared.
See Halling et al. (APLM 2012)
+++++++++++++++++++++++++++++++++++++
Question 5
"Verification" and "validation" pertain to FDA-approved/cleared and laboratory-developed tests respectively - True/False
+++++++++++++++++++++++++++++++++++++
Answer 5
True.
See Halling et al. (APLM 2012)
+++++++++++++++++++++++++++++++++++++
Question 6
The mnemonic PARR+AS+AS is most relevant to FDA-approved/cleared tests - True/False
+++++++++++++++++++++++++++++++++++++
Answer 6
False. LDT.
PARR for FDA-approved/cleared tests.
See Halling et al. (APLM 2012)
+++++++++++++++++++++++++++++++++++++
Question 7
Professional organizations or state agencies demonstrating that their accreditation requirements meet or exceed those specified by CLIA have "deemed status" from CMS (Centers for Medicare 7 Medicaid Services) to accredit laboratories - True/False
+++++++++++++++++++++++++++++++++++++
Answer 7
True.
See Jennings et al. (APLM 2009)
+++++++++++++++++++++++++++++++++++++
Question 8
When applied to qualitative tests, "accuracy" is equivalent to "sensitivity and specificity" - True/False
+++++++++++++++++++++++++++++++++++++
Answer 8
True.
See Jennings et al. (APLM 2009)
+++++++++++++++++++++++++++++++++++++
Question 9
True/False: Although the terms depth and coverage can be used interchangeably, coverage has also been used to denote the breadth of coverage of a target genome.
+++++++++++++++++++++++++++++++++++++
Answer 9
True.
See Sims et al. (Sequencing depth and coverage: key considerations in genomic analyses, 2014)
Commonly used metrics and quality control parameters used to assess run performance for NGS wet bench process documentation include:
A. Percentage of reads mapping to the target region
B. Fraction of bases meeting specified quality and coverage thresholds
C. Average coverage per base
+++++++++++++++++++++++++++++++++++++
Answer 1
All of the above.
See Aziz et al. (College of American Pathologists’ Laboratory Standards for Next-Generation Sequencing Clinical Tests APLM 2014)
+++++++++++++++++++++++++++++++++++++
Question 2
Essential performance characteristics that need to be determined during internal validation include:
A. Analytic sensitivity
B. Analytic specificity
C. Accuracy
D. Precision
E. Limit of detection
+++++++++++++++++++++++++++++++++++++
Answer 2
All of the above.
See Aziz et al. (College of American Pathologists’ Laboratory Standards for Next-Generation Sequencing Clinical Tests APLM 2014)
Question 3
According to the framework proposed by the ACCE, genetic tests should be evaluated on which of the following criteria:
A. Analytical validity
B. Clinical validity
C. Clinical utility
D. Ethical, legal and social issues
+++++++++++++++++++++++++++++++++++++
Answer 3
All of the above.
See Easton et al. (NEJM 2015)
+++++++++++++++++++++++++++++++++++++
Question 4
In vitro diagnostics that have gone through and passed a 510(k) trial are considered FDA-approved - True/False
+++++++++++++++++++++++++++++++++++++
Answer 4
False. FDA-cleared.
See Halling et al. (APLM 2012)
+++++++++++++++++++++++++++++++++++++
Question 5
"Verification" and "validation" pertain to FDA-approved/cleared and laboratory-developed tests respectively - True/False
+++++++++++++++++++++++++++++++++++++
Answer 5
True.
See Halling et al. (APLM 2012)
+++++++++++++++++++++++++++++++++++++
Question 6
The mnemonic PARR+AS+AS is most relevant to FDA-approved/cleared tests - True/False
+++++++++++++++++++++++++++++++++++++
Answer 6
False. LDT.
PARR for FDA-approved/cleared tests.
See Halling et al. (APLM 2012)
+++++++++++++++++++++++++++++++++++++
Question 7
Professional organizations or state agencies demonstrating that their accreditation requirements meet or exceed those specified by CLIA have "deemed status" from CMS (Centers for Medicare 7 Medicaid Services) to accredit laboratories - True/False
+++++++++++++++++++++++++++++++++++++
Answer 7
True.
See Jennings et al. (APLM 2009)
+++++++++++++++++++++++++++++++++++++
Question 8
When applied to qualitative tests, "accuracy" is equivalent to "sensitivity and specificity" - True/False
+++++++++++++++++++++++++++++++++++++
Answer 8
True.
See Jennings et al. (APLM 2009)
+++++++++++++++++++++++++++++++++++++
Question 9
True/False: Although the terms depth and coverage can be used interchangeably, coverage has also been used to denote the breadth of coverage of a target genome.
+++++++++++++++++++++++++++++++++++++
Answer 9
True.
See Sims et al. (Sequencing depth and coverage: key considerations in genomic analyses, 2014)
