PRELIM LAB 1: QUALITY ASSURANCE AND CONTROL Flashcards

(49 cards)

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
- 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
ANALYTICAL ACCURACY
26
- 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
PROFICIENCY TESTING
27
- 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
CONTROLS
28
- 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.
QUALITY ASSURANCE
29
- 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
QUALITY CONTROL MEASURE
30
- Essential document that provide detailed instruction on how to perform specific task/processes - Should be clear, detailed, and readily accessible to all laboratory personnel
DOCUMENT SOP
31
- Through training for laboratory staff on SOPs, protocols, and safety procedures - Regular assessment of competency personnel (ex: proficiency testing and training programs)
TRAINING AND COMPETENCY ASSESSMENT
32
Detect a specific target (cell surface protein/DNA mutation Analytic Specific Reagents (ASRs) OR In vitro Diagnostic Devices/Reagents
Analytic Specific Reagents (ASRs)
33
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
In vitro Diagnostic Devices/Reagents
34
Result verification Data interpretation Result reporting Storage of sample and data Archiving
POSTANALYTICAL PROCESS
35
DNA/RNA extraction DNA/RNA Quantification Purity Determination
ANALYTICAL PROCESS
36
Isolating nucleic acids (DNA/RNA from biological samples
DNA/RNA extraction
37
Characterization of nucleic acids
DNA/RNA Quantification
38
Assessing the presence of contaminants (proteins or organic compounds) in nucleic acid samples.
Purity Determination
39
Ability of test result to predict a clinical condition
Clinical sensitivity
40
Least detectable presence of the analyte
Detection limit, limit of detection
41
Disease-associated results only in patients who actually have the disease conditions
Clinical specificity
42
Agreement between independent test results
Precision
43
Consistency of test results produced from the same procedure
Reproducibility
44
The range within which a specimen may be measured directly (without dilution or concentration
Analyte measurement range
45
The range within which test results are considered to be valid (with or without dilution)
Reportable range
45
Expected analyte frequency or levels from a population of individuals
Reference range
46
Quantitative correlation between test result and actual amount of analyte
Linearity
47
CONTROLS: defines the lower limit of detection for more meaning interpretation of negative results
sensitivity control
48
distinguishes true-negative amplification results from false negatives resulting from amplification failure.
amplification control