Clinical Study Specimen Analysis

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10 Questions

What information is provided in the Run Details section?

Pouch information and run status

When can the Sample ID be edited?

After the run has been completed

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

Original and revised entries of changed fields

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

BIOFIRE 2.0 and BIOFIRE Torch Systems

What type of test is the BIOFIRE RP2.1?

Qualitative test

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

Clinical history and epidemiological data

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

Human specimens only

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

Clinical history and epidemiological data

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

For prescription use only

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

BIOFIRE 2.0 and BIOFIRE Torch Systems only

Learn about the analysis of Category I and Category II specimens in a clinical study, including reasons for specimen exclusion. Explore the testing procedures and protocols followed in the study.

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