Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

Molecular Diagnosis > Molecular QC & QA > Flashcards

Molecular QC & QA Flashcards

1
Q

Pre-analytical error is the consequence of

A

Erroneous or misleading results caused by events that occur prior to ample analysis

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is done upon receipt of specimen in lab?

A

Condition of specimen and chain of custody if possible.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

No specimen is accepted without

A

Proper labeling and identification

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What is done if specimen is unacceptable?

A

Disposal or retention is documented/recorded.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

All specimens are considered

A

Infectious

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

How should specimens be handled?

A

With standard precautions using proper personal protective equipment (gloves, glasses, coat)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What is absolutely required for handling RNA and why?

A

Gloves, to protect them from nuclease degradation.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What precautions are used for airborne or contact transmissible agents?

A

Transmission-based precautions like respirators.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Contact precautions are used for

A

direct patient care.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What are the requirements for molecular testing specimens?

A
  • Specimen with minimal cellular content accepted
  • Cross-contamination must be avoided
  • No hemolysis
  • NO WBC lysis, or DNA/RNA yield will be reduced
  • Solid tissues from fresh or frozen tissues
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Solid tissues are best analyzed from

A

Fresh or frozen tissue

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

the quality of the nucleic acid from fixed tissue depends on what?

A

Fixing process and fixative used.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What anticoagulants are used for molecular studies?

A

Brown: Sodium heparin
Lavender: Tripotassium EDTA
Yellow: Acid citrate dextrose solution

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Bench equipment requirement for dealing with RNA

A

Separate lab area designated RNase free

Wiped with RNase zap to get rid of RNase

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Disposables requirement when dealing with RNA

A

RNase free

Rinsed with 0.1% DEPC

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What should be added in RNA reactions?

A

Rnasin (promega)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What are the reagent requirements when dealing with RNA?

A

RNase free
0.05-0.1% DEPC added (except Tris)
Tested with RNase alert (Ambion)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

What must be taken into consideration with RNA/DNA extraction?

A

Sample type
Temperature stored
Longevity of tissue sample

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

What are the holding and storage requirements for DNA?

A

RT several months
4dC for at least a year
-20 to -70 dC for 10 years or longer

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

What are the holding and storage requirements for RNA?

A

RT or 4dC not recommended

  • 20dC for ~ 6 months if suspended in ethanol
  • 70dC for > 6 months is suspended in ethanol
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

What Federal structure requires validation of the performance of clinical methods and reagents in accurately identifying, detecting or measuring analytes prior to use in human testing? What is this called?

A

FDA. Test performance.

22
Q

What two criteria are used in identifying test performance?

A

Sensitivity and specificity

23
Q

How is clinical sensitivity calculated?

A

TP / TP+FN x 100

24
Q

How is clinical specificity calculated?

A

TN / TN+FP x 100

25
What is analytical sensitivity?
Smallest amount of substance in a sample that can be accurately measured.
26
What is clinical sensitivity?
Percent that a particular assay identifies true positive patients.
27
What is analytical specificity?
Ability of an assay to measure/identify a specific target/substance.
28
What is clinical specificity?
Percent that a particular assay identifies true negative patients.
29
What type of specimen is test validation performed on?
Specimens of types that will be encountered in routine use of the test.
30
The number of specimen tested in test validation varies with what?
Procedure and availability of test material.
31
Results of new test methodology are compared to what?
Results from established procedures or correlated to clinical diagnosis.
32
How are commercially developed and FDA-approved molecular methods verified?
Using purchased reagent sets to test validation in the lab
33
When a commercial test is modified, what happens?
Validation is required to show equal or superior performance of the modified procedure.
34
Once a procedure has been validated, it is documented in the lab according to
CLSI guidelines
35
What is proficiency testing?
External specimens from a source supplied to independent labs.
36
What structures supply the specimens for molecular analysis proficiency testing?
The CAP and other organizations
37
What is the solution when proficiency testing specimens are not commercially available?
Labs exchange blinded split specimens or blinded specimens measured/documented by independent means such as chart review are tested within the lab.
38
What are controls?
Samples of known type or amount that are treated like and ran with patient samples.
39
What controls are needed in qualitative tests?
Positive control Negative control Sometimes sensitivity control
40
What controls are needed in quantitative tests?
High positive control Low positive control Negative control
41
What is different with amplification procedures?
Amplification control is needed to avoid false-negative results.
42
What do quantitative PCR methods that automatically analyze results need?
Standard curve or dilution series of the positive control.
43
A standard curve or dilution series of the positive control is seen in what procedures?
Quantitative PCR
44
What do methods requiring detection of a target-specific product or relative amounts of a target?
Internal controls ran simultaneously preferably in the same reaction mix as the test specimen.
45
What is quality assurance?
Periodic review and documentation of test results
46
Molecular quantitative methods should have a defined
Dynamic range Sensitivity level Accuracy
47
What are cut-off values?
levels that distinguish positive from negative results in an assay
48
Who supplies recommendations for routine maintenance?
Manufacturers
49
What is required for detection systems?
Regular calibration or fitting of instrument/test system with the actual concentration of reference analyze.
50
What are analyte-specific reagents (ASR)?
Probes, primers, Ab or other test components that detect a specific target.

Molecular Diagnosis (11 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions