Podcast
Questions and Answers
How are the outcomes of a new test compared during validation?
How are the outcomes of a new test compared during validation?
- Against established procedures or clinical diagnosis (correct)
- Against the clinical diagnosis only
- Against the developer's predictions
- Against historical laboratory data
- Against results from different laboratories
Which storage condition is NOT advisable for isolated RNA?
Which storage condition is NOT advisable for isolated RNA?
- Room temperature
- Diethylpyrocarbonate-treated water (correct)
- Refrigerator temperature
- Ethanol at -20°C
- Ethanol at -70°C
What types of specimens are utilized for test validation?
What types of specimens are utilized for test validation?
- Only frozen tissue
- Only cultured cells
- Various types encountered in routine use (correct)
- Only body fluids
- Only paraffin-embedded tissue
What is crucial for the prolonged viability of RNA?
What is crucial for the prolonged viability of RNA?
When integrating predeveloped and FDA-approved molecular methods, what is ascertained?
When integrating predeveloped and FDA-approved molecular methods, what is ascertained?
How long can RNA suspended in ethanol remain stable at -20°C?
How long can RNA suspended in ethanol remain stable at -20°C?
What is a crucial step in ensuring accurate test results according to the text?
What is a crucial step in ensuring accurate test results according to the text?
Where should calculations and comparisons with standards be documented?
Where should calculations and comparisons with standards be documented?
What is NOT true regarding periodic review and documentation of test results for clinical testing, including molecular tests?
What is NOT true regarding periodic review and documentation of test results for clinical testing, including molecular tests?
What is an essential part of the validation process for molecular quantitative methods?
What is an essential part of the validation process for molecular quantitative methods?
Why is it important to establish a direct correlation in test procedures?
Why is it important to establish a direct correlation in test procedures?
What role does periodic monitoring play in the context of test validation?
What role does periodic monitoring play in the context of test validation?
Which of the following is the primary purpose of including high, low, sensitivity, and negative standards in each run?
Which of the following is the primary purpose of including high, low, sensitivity, and negative standards in each run?
How are critical values that require physician notification typically established and confirmed?
How are critical values that require physician notification typically established and confirmed?
Which statement about assay levels (cut-off values) is true?
Which statement about assay levels (cut-off values) is true?
How is the linear range of an assay typically established?
How is the linear range of an assay typically established?
Which of the following is NOT typically included as part of the validation process for a diagnostic assay?
Which of the following is NOT typically included as part of the validation process for a diagnostic assay?
Which of the following statements about the purpose of including standards in each run is correct?
Which of the following statements about the purpose of including standards in each run is correct?
