Interpreting Test Results and Standard Curve in Lab Analysis

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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?

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?

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?

Proper handling of the specimen Signup and view all the answers

When integrating predeveloped and FDA-approved molecular methods, what is ascertained?

The established procedures Signup and view all the answers

How long can RNA suspended in ethanol remain stable at -20°C?

Several months Signup and view all the answers

What is a crucial step in ensuring accurate test results according to the text?

Using a standard curve Signup and view all the answers

Where should calculations and comparisons with standards be documented?

In the laboratory procedure manual Signup and view all the answers

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. Signup and view all the answers

What is an essential part of the validation process for molecular quantitative methods?

Defining band patterns, melt curves, and peak characteristics Signup and view all the answers

Why is it important to establish a direct correlation in test procedures?

To enhance the accuracy of test results Signup and view all the answers

What role does periodic monitoring play in the context of test validation?

It identifies trends or shifts in rates of positive or negative results. Signup and view all the answers

Which of the following is the primary purpose of including high, low, sensitivity, and negative standards in each run?

To monitor test performance Signup and view all the answers

How are critical values that require physician notification typically established and confirmed?

During the validation process Signup and view all the answers

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. Signup and view all the answers

How is the linear range of an assay typically established?

During the validation process Signup and view all the answers

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 Signup and view all the answers

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 Signup and view all the answers

Interpreting Test Results and Standard Curve in Lab Analysis

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