LABORATORY OPERATIONS Flashcards

1
Q

How should an optimal positive control be produced?

A

In the exact same conditions as the patient tissue (fixation, processing, staining) and cut onto the same slide.

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2
Q

How can you validate a prediluted antibody?

A

By performing a serial dilution (1:2, 1:4, 1:8 and 1:16) and assessing for reactivity on known positive tissue.

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3
Q

What is the one prediluted antibody that can be run without additional lot validation?

A

FDA approved pre diluted antibody

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4
Q

Define concentrated antibody

A

A non-diluted antibody in which several serial dilutions must be performed in order to find the optimal dilution. Called “prep kits” in Vancouver.

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5
Q

Are diluted or concentrated antibody more practical?

A

Concentrated

Much more shelf stable and are much cheaper than diluted antibody

Concentrated antibody also give the user much more control over antibody expression in patient tissue

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6
Q

How do you make a1:20 diluted antibody?

A

1 part antibody
19 parts diluent totaling up to 20 parts

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7
Q

What is a lambda in reference to measurement?

A

An old fashioned way to say microliter

Same as micron=micrometer

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8
Q

Define reagent control

A
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9
Q

Define procedure control

A
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10
Q

Define a positive tissue control

A
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11
Q

Define a negative tissue control

A
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12
Q

Define an internal tissue control

A
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13
Q

What are the four common negative control reagents used in place of the primary antibody?

A

1.
2.
3.
4.

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14
Q

What two negative control reagents detect non-specific background staining?

A
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15
Q

Which control types validate the staining steps?

A
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16
Q

Which control types validate fixation and processing?

A
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17
Q

Which antigen can be used as a control to evaluate fixation quality?

A

Vimentin

18
Q

Which control type assists with evaluation of prognostic and predictive IHC assays?

A
19
Q

What are the three characteristics of an optimal positive control?

A

1.
2.
3.

20
Q

What are the optimal storage options for control tissue?

A
21
Q

What are the advantages of purchased control tissue?

A
22
Q

What are the disadvantages of purchased control tissue?

A
23
Q

What issues must be considered when selecting control tissues?

A
24
Q

Explain the use of multi-tissue blocks

A
25
Q

Define lot validation

A
26
Q

Describe a method for lot validation

A
27
Q

Explain procedure validation

A
28
Q

Describe a method for procedure validation

A
29
Q

Explain antibody validation

A
30
Q
A
31
Q

Describe a method for antibody validation

A
32
Q

Describe a method for control tissue validation

A
33
Q

What records are recommended for control validations?

A
34
Q

Define ASR

A
35
Q

What regulations pertain to ASR?

A
36
Q

Define IVD

A
37
Q

What regulations pertain to IVD?

A
38
Q

Define RUO

A
39
Q

What regulations pertain to RUO?

A
40
Q

How does the ASR/IVDF/RUO

A