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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

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2
Q

What is done upon receipt of specimen in lab?

A

Condition of specimen and chain of custody if possible.

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3
Q

No specimen is accepted without

A

Proper labeling and identification

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4
Q

What is done if specimen is unacceptable?

A

Disposal or retention is documented/recorded.

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5
Q

All specimens are considered

A

Infectious

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6
Q

How should specimens be handled?

A

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

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7
Q

What is absolutely required for handling RNA and why?

A

Gloves, to protect them from nuclease degradation.

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8
Q

What precautions are used for airborne or contact transmissible agents?

A

Transmission-based precautions like respirators.

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9
Q

Contact precautions are used for

A

direct patient care.

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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
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11
Q

Solid tissues are best analyzed from

A

Fresh or frozen tissue

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12
Q

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

A

Fixing process and fixative used.

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13
Q

What anticoagulants are used for molecular studies?

A

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

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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

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15
Q

Disposables requirement when dealing with RNA

A

RNase free

Rinsed with 0.1% DEPC

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16
Q

What should be added in RNA reactions?

A

Rnasin (promega)

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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)

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18
Q

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

A

Sample type
Temperature stored
Longevity of tissue sample

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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

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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
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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
Q

What is analytical sensitivity?

A

Smallest amount of substance in a sample that can be accurately measured.

26
Q

What is clinical sensitivity?

A

Percent that a particular assay identifies true positive patients.

27
Q

What is analytical specificity?

A

Ability of an assay to measure/identify a specific target/substance.

28
Q

What is clinical specificity?

A

Percent that a particular assay identifies true negative patients.

29
Q

What type of specimen is test validation performed on?

A

Specimens of types that will be encountered in routine use of the test.

30
Q

The number of specimen tested in test validation varies with what?

A

Procedure and availability of test material.

31
Q

Results of new test methodology are compared to what?

A

Results from established procedures or correlated to clinical diagnosis.

32
Q

How are commercially developed and FDA-approved molecular methods verified?

A

Using purchased reagent sets to test validation in the lab

33
Q

When a commercial test is modified, what happens?

A

Validation is required to show equal or superior performance of the modified procedure.

34
Q

Once a procedure has been validated, it is documented in the lab according to

A

CLSI guidelines

35
Q

What is proficiency testing?

A

External specimens from a source supplied to independent labs.

36
Q

What structures supply the specimens for molecular analysis proficiency testing?

A

The CAP and other organizations

37
Q

What is the solution when proficiency testing specimens are not commercially available?

A

Labs exchange blinded split specimens or blinded specimens measured/documented by independent means such as chart review are tested within the lab.

38
Q

What are controls?

A

Samples of known type or amount that are treated like and ran with patient samples.

39
Q

What controls are needed in qualitative tests?

A

Positive control
Negative control
Sometimes sensitivity control

40
Q

What controls are needed in quantitative tests?

A

High positive control
Low positive control
Negative control

41
Q

What is different with amplification procedures?

A

Amplification control is needed to avoid false-negative results.

42
Q

What do quantitative PCR methods that automatically analyze results need?

A

Standard curve or dilution series of the positive control.

43
Q

A standard curve or dilution series of the positive control is seen in what procedures?

A

Quantitative PCR

44
Q

What do methods requiring detection of a target-specific product or relative amounts of a target?

A

Internal controls ran simultaneously preferably in the same reaction mix as the test specimen.

45
Q

What is quality assurance?

A

Periodic review and documentation of test results

46
Q

Molecular quantitative methods should have a defined

A

Dynamic range
Sensitivity level
Accuracy

47
Q

What are cut-off values?

A

levels that distinguish positive from negative results in an assay

48
Q

Who supplies recommendations for routine maintenance?

A

Manufacturers

49
Q

What is required for detection systems?

A

Regular calibration or fitting of instrument/test system with the actual concentration of reference analyze.

50
Q

What are analyte-specific reagents (ASR)?

A

Probes, primers, Ab or other test components that detect a specific target.

Molecular Diagnosis (11 decks)

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