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Clinical Study Specimen Analysis

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Questions and Answers

What information is provided in the Run Details section?

Sample ID and operator information

Instrument used and protocol followed

Pouch information and run status (correct)

Change summary and operator identity

When can the Sample ID be edited?

During the test execution

Only if there is an instrument error

Before starting the run

After the run has been completed (correct)

What does the Change Summary section of the test report contain?

List of all system errors encountered

Original and revised entries of changed fields (correct)

Details of all operators involved

Additional protocols added to the test

Which system is the BIOFIRE RP2.1 performance established on?

BIOFIRE 2.0 and BIOFIRE Torch Systems Signup and view all the answers

What type of test is the BIOFIRE RP2.1?

Qualitative test Signup and view all the answers

What should results from the BIOFIRE RP2.1 test be correlated with?

Clinical history and epidemiological data Signup and view all the answers

What kind of specimens is the BIOFIRE RP2.1 evaluated for use with?

Human specimens only Signup and view all the answers

What should be considered when evaluating results from the BIOFIRE RP2.1?

Clinical history and epidemiological data Signup and view all the answers

What is a key limitation mentioned for the BIOFIRE RP2.1 test?

For prescription use only Signup and view all the answers

What kind of systems are compatible with the BIOFIRE RP2.1 performance?

BIOFIRE 2.0 and BIOFIRE Torch Systems only Signup and view all the answers