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MOL. BIO LAB > PRELIM LAB 1: QUALITY ASSURANCE AND CONTROL > Flashcards

PRELIM LAB 1: QUALITY ASSURANCE AND CONTROL Flashcards

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Biology 101 flashcards
1
Q

wide range of techniques and methods used to study biomolecules (DNA, RNA, proteins, nucleic acids and other protein molecules)

A

MOLECULAR ANALYSIS

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2
Q

Main purpose: for diagnostic or investigative purposes
- SPECIFIC APPLICATION OF MOLECULAR ANALYSIS TECHNIQUES
- To define a treatment strategy for individual patient
- Should be made appropriately and should be offered in a timely manner to achieve accurate and effective results

A

MOLECULAR TESTING

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3
Q

Workflow Molecular Test
activities that occur BEFORE the actual analysis of specimen

A

PREANALYTICAL PROCESS

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4
Q

Workflow Molecular Test
ACTUAL TESTING and analysis of the specimen in laboratory
Ex: extraction of DNA and RNA in cell

A

ANALYTICAL PROCESS

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5
Q

Workflow Molecular Test
- activities that occur AFTER the analytical testing is complete and results is generated

A

POSTANALYTICAL PROCESS

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6
Q

errors encountered in preanalytical process

A

PREANALYTICAL ERRORS

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7
Q

An aliquot removed from a specimen is NEVER RETURNED to the original tube or vessel

T OR F?

A

TRUE

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8
Q

Collection Tubes for Molecular Testing
chemistry, serum, viral antibody

A

RED

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9
Q

Collection Tubes for Molecular Testing
molecular biology studies

A

YELLOW

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10
Q

Collection Tubes for Molecular Testing
Immunology, virology

A

GREEN

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11
Q

Collection Tubes for Molecular Testing
Virology, molecular biology studies

A

LAVENDER

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12
Q

Collection Tubes for Molecular Testing
cytogenetics studies & molecular studies

A

BROWN

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13
Q

Special Collection Tubes
- WBC separation upon configuration and also used for HIV, HCV analysis
Tubes designed to stabilize RNA.

A

PLASMA PREPARATION TUBE (PPT)

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14
Q
  • Designed by Center Disease Control and Prevention (CDC)
  • A SET OF INFECTION PRECAUTION PRACTICES to protect the transmission of infectious diseases
  • Hand hygiene, PPE, safe handling of sharps
  • Transmission based precautions: prevents airborne/contact transmissible agents
  • Contact precautions: for direct patient care where there is the potential for direct exposure to infectious agents on or from the patient
A

STANDARD PRECAUTION

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15
Q

Common Decontamination Agent

A

Heat
Ethylene oxide
Glutaraldehyde
10 % Hydrogen peroxide
10% Formalin
5.25% Hypochlorite
Formaldehyde
Detergents
Phenols
UV radiation
Ionizing radiation
Photo-oxidation

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16
Q

developed a series of warning label for universal use on all chemical container
Ex: chemical has the following NFPA hazard

A

NATIONAL FIRE PROTECTION ASSOCIATION (NFPA)

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17
Q

documents that provide information about the properties, hazards, handling, storage and emergency measures for substances/mixtures

A

MATERIAL SAFETY DATA SHEETS (MSDS)

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18
Q

___________require validation of the performance of clinical test methods & reagents in accurately detecting/ measuring analytes prior to use in human testing

A

FOOD AND DRUG ADMINISTRATION (FDA)

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19
Q

Outcome where the model correctly predicts the positive class

A

TRUE POSITIVE

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20
Q

Outcome where the model correctly predicts negative class

A

TRUE NEGATIVE

21
Q

Outcome where the model incorrectly predicts the positive class

A

FALSE POSITIVE

22
Q

Outcome where the model incorrectly predicts the negative class

A

FALSE NEGATIVE

23
Q
  • CHANGE IN ASSAY RESPONSE with corresponding change in analyte
    Ex: All positive reference standard tested positive with the new assay and the analytical sensitivity of the assay is 100 %
  • TP/ TP + FN × 100

ANALYTICAL SPECIFICITY
ANALYTICAL ACCURACY
ANALYTICAL SENSITIVITY

A

ANALYTICAL SENSITIVITY

24
Q
  • ABILITY TO DETECT ONLY THE ANALYTE and not nonspecific targets
    Ex: The invader assay for factor V Leiden successfully detected mutation in 18 positive specimen while yielding negative results (for 30 normal specimens
    TP/TN + FN × 100

ANALYTICAL SPECIFICITY
ANALYTICAL ACCURACY
ANALYTICAL SENSITIVITY

A

ANALYTICAL SPECIFICITY

25
Q
  • PRODICTION OF CORRECT RESULTS
    Ex: Of 100 specimens with mutations in HCM gene, 90 are detected by sequencing with no mutations detected in normal specimens
  • TN + TP/TN + TP + FN + FP × 100

ANALYTICAL SPECIFICITY
ANALYTICAL ACCURACY
ANALYTICAL SENSITIVITY

A

ANALYTICAL ACCURACY

26
Q
  • Refers to external specimen from reference source supplied to independent laboratories
  • Determines the performance individual laboratory for specific tests/measurement and is used to monitor laboratory continuing performance
  • Performed at least 2x a year

CONTROLS
PROFICIENCY TESTING
VALIDATION

A

PROFICIENCY TESTING

27
Q
  • Sample of known type/amount that are treated like and run with patient specimen
  • Serve as reference points to validate and monitor various steps of molecular experiments, ensuring the reliability of and accuracy of results

CONTROLS
PROFICIENCY TESTING
VALIDATION

A

CONTROLS

28
Q
  • Range of activities that enable laboratory to achieve high level of accuracy and proficiency
  • Periodic review and documentation of test result is required
  • Monitored controls and conditions are reviewed monthly at determined intervals to document outliers/systems errors.
A

QUALITY ASSURANCE

29
Q
  • Systematic process and procedures to monitor, assess and ensure the accuracy, precision and reliability of molecule assays and experiments
  • Use positive, negative and sensitivity control to monitor assay performance
A

QUALITY CONTROL MEASURE

30
Q
  • Essential document that provide detailed instruction on how to perform specific task/processes
  • Should be clear, detailed, and readily accessible to all laboratory personnel
A

DOCUMENT SOP

31
Q
  • Through training for laboratory staff on SOPs, protocols, and safety procedures
  • Regular assessment of competency personnel (ex: proficiency testing and training programs)
A

TRAINING AND COMPETENCY ASSESSMENT

32
Q

Detect a specific target (cell surface protein/DNA mutation

Analytic Specific Reagents (ASRs)
OR
In vitro Diagnostic Devices/Reagents

A

Analytic Specific Reagents (ASRs)

33
Q

for use in the diagnosis of disease, products that may be to collect, prepare and examine specimen

Analytic Specific Reagents (ASRs)
OR
In vitro Diagnostic Devices/Reagents

A

In vitro Diagnostic Devices/Reagents

34
Q

Result verification
Data interpretation
Result reporting
Storage of sample and data
Archiving

A

POSTANALYTICAL PROCESS

35
Q

DNA/RNA extraction
DNA/RNA Quantification
Purity Determination

A

ANALYTICAL PROCESS

36
Q

Isolating nucleic acids (DNA/RNA from biological samples

A

DNA/RNA extraction

37
Q

Characterization of nucleic acids

A

DNA/RNA Quantification

38
Q

Assessing the presence of contaminants (proteins or organic compounds) in nucleic acid samples.

A

Purity Determination

39
Q

Ability of test result to predict a clinical
condition

A

Clinical sensitivity

40
Q

Least detectable presence of the analyte

A

Detection limit, limit
of detection

41
Q

Disease-associated results only in patients
who actually have the disease conditions

A

Clinical specificity

42
Q

Agreement between independent test
results

A

Precision

43
Q

Consistency of test results produced from
the same procedure

A

Reproducibility

44
Q

The range within which a specimen may be measured directly (without dilution or
concentration

A

Analyte measurement range

45
Q

The range within which test results are considered to be valid (with or without
dilution)

A

Reportable range

45
Q

Expected analyte frequency or levels from
a population of individuals

A

Reference range

46
Q

Quantitative correlation between test result and actual amount of analyte

A

Linearity

47
Q

CONTROLS:
defines the lower limit of detection for more meaning interpretation of negative results

A

sensitivity control

48
Q

distinguishes true-negative amplification results from false negatives resulting from amplification failure.

A

amplification control

MOL. BIO LAB (9 decks)

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