18 Questions
How are the outcomes of a new test compared during validation?
Against established procedures or clinical diagnosis
Which storage condition is NOT advisable for isolated RNA?
Diethylpyrocarbonate-treated water
What types of specimens are utilized for test validation?
Various types encountered in routine use
What is crucial for the prolonged viability of RNA?
Proper handling of the specimen
When integrating predeveloped and FDA-approved molecular methods, what is ascertained?
The established procedures
How long can RNA suspended in ethanol remain stable at -20°C?
Several months
What is a crucial step in ensuring accurate test results according to the text?
Using a standard curve
Where should calculations and comparisons with standards be documented?
In the laboratory procedure manual
What is NOT true regarding periodic review and documentation of test results for clinical testing, including molecular tests?
Test performance is not monitored in molecular quantitative methods.
What is an essential part of the validation process for molecular quantitative methods?
Defining band patterns, melt curves, and peak characteristics
Why is it important to establish a direct correlation in test procedures?
To enhance the accuracy of test results
What role does periodic monitoring play in the context of test validation?
It identifies trends or shifts in rates of positive or negative results.
Which of the following is the primary purpose of including high, low, sensitivity, and negative standards in each run?
To monitor test performance
How are critical values that require physician notification typically established and confirmed?
During the validation process
Which statement about assay levels (cut-off values) is true?
They distinguish positive from negative results and must be well defined and verified at regular intervals.
How is the linear range of an assay typically established?
During the validation process
Which of the following is NOT typically included as part of the validation process for a diagnostic assay?
Establishing the narrow temperature range for viral types
Which of the following statements about the purpose of including standards in each run is correct?
To monitor the performance of the test and ensure consistent results
Learn how to observe raw data and interpret final results in laboratory analysis. Understand the importance of calculating and comparing with standards to verify test results.
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