60-00398-1miniVIDAS® Online Workbook © 2009 bioMérieux, Inc. Chapter 6, Page 1 of 5

Chapter 6: Interpreting Test Results

OBJECTIVES

Upon completion of this chapter, you will be able to: • Identify information found in assay report headers and results

portion • Describe function of a threshold • Calculate relative fluorescent values (RFV) and test values • Interpret assay report results in terms of Standard, Calibrator and

Control PRINTING & VIEWING INSTRUCTIONS

Print (preferably in color) and read the objectives and questions for each chapter prior to viewing the associated video. Questions may be answered as you view the video. For specific instructions on video viewing, please refer to the Getting Started link. GUIDED VIEWING QUESTIONS

When an assay is complete, a report of the results will automatically print on the internal printer. All assay reports are similar but not identical.

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1. The quantitative assay report headers include specific information.

Read each description below and determine which item(s) is/are NOT included in the report header by placing an “X” in the appropriate space. _____ Name of institution or lab, if configured _____ Section in which assay was run _____ Date and time assay was completed _____ User ID, if configured _____ Threshold _____ Assay name and code _____ Date and time standard was run _____ Mean relative fluorescent value (RFV) of the standard

2. The result portion of the assay report also includes very specific information. Read each description below and determine which item(s) IS/ARE included in the result portion by placing an “X” in the appropriate space. _____ Threshold _____ Sample position _____ Background reading and RFV of each strip _____ Result

Read the statements below and circle the correct letter for each answer.

3. The threshold determines ______.

A. whether a result is positive, negative or equivocal B. the RFV C. the test value, which is calculated from the difference between

the sample RFV and the standard RFV D. the calibration curve to determine analyte concentrations

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4. The relative fluorescent value (RFV) is calculated at the end of a run

by _____. A. subtracting the final fluorescent reading from the background

fluorescent reading B. adding the final fluorescent reading to the background

fluorescent reading C. subtracting the background fluorescent reading from the final

fluorescent reading D. adding the background fluorescent reading to the final

fluorescent reading 5. Qualitative assays also have a test value. One method of

calculating this test value is to _____. A. subtract the sample RFV from the standard RFV B. add the sample RFV to the standard RFV C. subtract the standard RFV from the sample RFV D. add the standard RFV to the sample RFV

6. Comparing the test value to a set of thresholds determines the _____. A. result B. ratio C. difference between the RFV and the background number D. mean

7. For ______ test results the package insert recommends repeating

with a fresh specimen or repeating the assay with the original sample. In the event the same result is achieved after the second testing another testing method is recommended. A. positive B. equivocal C. negative D. neutral

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Determine whether each statement is correct or incorrect by circling either “True” or “False”. 8. When calibrators and standards are correctly defined, only a

background number and RFV will appear on the results printout of a D-dimer assay.

True False

9. Quantitative assays use a calibration curve to determine analyte concentrations in test samples.

True False

10. Operators may report patient results when controls are out of range

as long as they provide an explanation with the results.

True False

11. The miniVIDAS® will not flag either internal or external controls that fall out of the expected range therefore, the operator must check the expected ranges on the control’s package insert and verify that they are within acceptable range.

True False

12. Although expected values for patient results are listed in each

specific VIDAS® assay package insert, each lab should establish its own expected values on a well-defined population.

True False

13. When running a diluted sample, an operator must enter a dilution

factor in order for the miniVIDAS to automatically multiply the result.

True False

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14. What is the assay name and code of this test?

A. Section A B. Toxo IgG Avidity (TXGA) C. 300068113 D. R5.2.0