AP-HIS-501 New Reagent Lot Confirmation of Acceptability
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Questions and Answers

What is the purpose of this procedure?

  • To compare new antibody/probe detection system reagent lot numbers to previous lot numbers. (correct)
  • To control for variables such as disparity in the lots of detection reagents or instrument function.
  • To confirm the acceptability of a new reagent lot before patient testing.
  • To test one antibody or detection kit at a time to avoid confusion.

    • True or false: The laboratory must use a multi-tissue control when testing new antibody or detection kit lots?

    True

    What is the purpose of this procedure?

    The purpose of this procedure is to compare new antibody/probe detection system reagent lot numbers to previous lot numbers concurrently or before being placed into service.

    What should the IHC section of the laboratory do before patient testing?

    <p>Confirm the acceptability of a new reagent lot</p> Signup and view all the answers

    What must be performed to control for variables such as disparity in the lots of detection reagents or instrument function?

    <p>Parallel staining</p> Signup and view all the answers

    What must be done to control for variables such as disparity in the lots of detection reagents or instrument function?

    <p>Perform parallel staining</p> Signup and view all the answers

    True or false: The laboratory must test one antibody or detection kit at a time?

    <p>True</p> Signup and view all the answers

    What quality control measures are used in this procedure?

    <p>Quality control measures include a multi-tissue control (for detection verification, and U6 probe) and one positive control.</p> Signup and view all the answers

    What must be printed at the end of the procedure?

    <p>Date and time</p> Signup and view all the answers

    True or false: The laboratory should use the same block of tissue for parallel staining with the two detection kits?

    <p>True</p> Signup and view all the answers

    What is the role of the Immunohistochemistry (IHC) section of the laboratory?

    <p>The Immunohistochemistry (IHC) section of the laboratory must confirm the acceptability of a new reagent lot before patient testing and test one antibody or detection kit at a time to avoid confusion.</p> Signup and view all the answers

    What must the laboratory do to confirm the acceptability of a new reagent lot before patient testing?

    <p>Run a viability test</p> Signup and view all the answers

    What must be used in order to perform parallel staining?

    <p>Known positive and one known negative</p> Signup and view all the answers

    True or false: A viability test should be used to compare new reagent lots to previous reagent lots?

    <p>True</p> Signup and view all the answers

    What type of control should be used to verify detection?

    <p>Multi-tissue control</p> Signup and view all the answers

    What is the procedure for comparing the reagent lots?

    <p>The IHC staining has to be performed with the old lot on the first run and the new lot on the same run (utilizing the landing zone feature on the Ventana software for the new lot) due to the fact the instrument will select the older reagent if both lots were placed at the beginning of the run.</p> Signup and view all the answers

    What should be done to avoid confusion when testing one antibody or detection kit?

    <p>Test one at a time</p> Signup and view all the answers

    What is the final step in the procedure?

    <p>The final step is to run a viability test to confirm the reagent and compare it to previous reagent lots and applicable datasheets.</p> Signup and view all the answers

    True or false: The laboratory should use the landing zone feature on the Ventana software for the new lot?

    <p>True</p> Signup and view all the answers

    What is the date of the printed text?

    <p>01-Mar-2023</p> Signup and view all the answers

    Study Notes

    • The purpose of this procedure is to compare new antibody/probe detection system reagent lot numbers to previous lot numbers concurrently or before being placed into service.
    • For Immunohistochemistry (IHC) parallel staining using one known positive and one known negative will be performed on the same instrument with the two detection kits using the different multi-tissue control tissue.
    • This comparison should be made on slides cut from the same control block. Parallel staining is required to control for variables such as disparity in the lots of detection reagents or instrument function.
    • The IHC staining has to be performed with the old lot on the first run and the new lot on the same run (utilizing the landing zone feature on the Ventana software for the new lot) due to the fact the instrument will select the older reagent if both lots were placed at the beginning of the run.
    • Quality control measures include a multi-tissue control (for detection verification, and U6 probe).
    • One positive control will be used.
    • The Immunohistochemistry (IHC) section of the laboratory must confirm the acceptability of a new reagent lot before patient testing.
    • The Immunohistochemistry (IHC) section of the laboratory must test one antibody or detection kit at a time to avoid confusion.
    • If the aforementioned happens and a positive and a negative result are obtained, the laboratory will run a viability test to confirm the reagent and compare it to previous reagent lots and applicable datasheets.
    • printed by Jacqueline Poinsette on 01-Mar-2023 9:11 (CST). Page 5 of 5

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