Lab: Guidance for Molecular Clinical Laboratory

Question 1

A GOLD standard testing

Answer 1

Molecular testing

Question 2

The process of diagnostic analysis begins with

Answer 2

Evaluation
Selection
Implementation

Question 3

The second step is to

Answer 3

Incorporate guidance for health care providers

Question 4

The final process is to

Answer 4

“Ensure timely” collection, transport, processing, and reporting of results

Question 5

All molecular diagnosis workflows can be divided into.

Answer 5

Pre analytical, Analytical, and Post analytical

Question 6

Aim at quality, format, and amount of
specimen/sample, which should be
documented in detail.

Answer 6

Pre analytical standards

Question 7

Analytical standards

Answer 7

Consider the “proof of these aspects”,
concerning DNA/RNA extraction,
quantification, and purity determination
via fluorometry or spectrophotometry.

Question 8

Mainly focuses on the documentation and
bioinformatics process.

Answer 8

Post analytical analysis

Question 9

Allow _________ to be allocated to samples as they enter the laboratory.

Answer 9

Accession numbers

Question 10

Allow accession numbers to be allocated to samples as they enter the laboratory as per

Answer 10

ISO 15189 and ISO 9001

Question 11

SOPs means

Answer 11

Standard operating procedures

Question 12

The SOPs should follow

Answer 12

ISO 15189

Question 13

True or False:
The use of fixed tissue that has been frozen previously is advised.

Answer 13

FALSE, This only applies to TISSUES.

Question 14

The number one fixing reagent in
Histopath lab is

Answer 14

Formalin

Question 15

Decalcification means

Answer 15

Removing the calcium from a tissue

Question 16

True or False:
Decalcification may reduce DNA and particularly RNA recovery

Answer 16

TRUE

Question 17

Specimen requirements for molecular diagnosis can be highly variable, depending on the:

Answer 17

Disease setting,
Individual practices of acquisition,
Tissue handling,
Processing protocols, and
Testing method

Question 18

Quality control (QC) must be clear and done _____

Answer 18

Periodically

Question 19

Before running a test, make sure that the
reagents are in its

Answer 19

Optimal condition

Question 20

These measure total nucleic acids as well as impurities that markedly overestimate amplifiable DNA or RNA content.

Answer 20

Spectrophotometric methods

Question 21

Advantages of Spectrophotometer

Answer 21

More readily available in the market and is
cheaper.

Question 22

For stool testing, however, might supplant monoplex PCR assays for viral and parasitic pathogens

Answer 22

Multiplex PCR Assays

Question 23

Factors to be considered when choosing an Analytical Method

Answer 23

Number of samples
Number of genes
Percentage of mutations
Amount of tissue available
Degree of staff expertise
Equipment and infrastructure required separation of stages in different compartments

Question 24

Under A260/A280nm read:
1.8 means

Answer 24

Pure DNA

Question 25

> 1.8

Answer 25

Proteins and solvents contaminants

Question 26

> 2.0

Answer 26

Chloroform or Phenol contaminants

Question 27

2.0

Answer 27

Pure RNA

Question 28

Storage of DNA & RNA required temperature is

Answer 28

-20ºC or lower

Question 29

Used to investigate fragment size distribution and final library
quality assessment of the sample.

Answer 29

Capillary gel electrophoresis

Question 30

Determine the input DNA/RNA amount and to check sample quality

Answer 30

Fluorometer

Question 31

The time/period on where the
molecular test releases the result.

Answer 31

TAT (Turn around time)

Question 32

Three key areas that should
be included in Molecular Diagnostic Reports.

Answer 32

1. Patient Identification
2. Reporting Style and Content
3. Interpretation

Question 33

True or False:
There should be a total of 3 identifiers in Patient Identification

Answer 33

TRUE

Question 34

True or False:
One page, or better still, single-screen reports are preferred in Reporting Style and Content

Answer 34

TRUE

Question 35

Also known as proficiency testing (PT), are inevitable for monitoring of performance of the lab.

Answer 35

External Quality assurance (EQA)

Question 36

Is necessary to ensure high assay reproducibility and performance and enable detection and correction
of errors in daily practice.

Answer 36

Internal Quality Assurance (IQA)

Question 37

Check for volumetric accuracy and
reproducibility, and recalibrate at least _____

Answer 37

once every 6 months (twice a year).

Question 38

Thermometers: Test against a standardized thermometric device annually

Answer 38

Once a year

Question 39

Refrigerated centrifuge and
must be maintained within

Answer 39

2-6°C.

Question 40

the NABs (National Body) will perform surveillance visits typically

Answer 40

Every 1 to 2 years.