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Nationwide replacement of High Volume Chemistry analyzers – Infectious Disease Serology Tests (Hepatitis and Rubella) in Ontario

August 19 2022
Throughout this fall and winter we will be gradually replacing Roche and Abbott analyzers used nationally for High Volume Chemistry, which includes immunoassays, clinical chemistry, and infectious disease (serology) testing.

Dear health care providers,

The quality of our organization’s technology infrastructure serves as an important pillar to ensuring we continue to offer you and your patients timely and accurate laboratory diagnostic testing services. To support this, it is imperative we conduct routine updates on a national scale to our instrument fleet with new technology that will perform quality assays.

We are pleased to share that throughout this fall and winter we will be gradually replacing Roche and Abbott analyzers used nationally for High Volume Chemistry, which includes immunoassays, clinical chemistry, and infectious disease (serology) testing.

In the first phase, the tests used for infectious disease serology (Hepatitis and Rubella) will transfer to the Abbott Alinity i platform on Sunday, August 21, 2022, so that the new analyzers are live by August 22 for all our Ontario clients. 

We do not anticipate these changes will impact the turnaround time of your patients’ test results.

The test results on the new platform compare well with our current platform. Table 1 provides a list of serology tests moving to the new testing platform along with a description of notable changes. We will be providing regular updates on the changes to other tests as they become available.

 

Table 1. Tests that are being transferred to the Abbott Alinity i platform.

Tests switching from the Roche Cobas e602 to the Abbott Alinity i platform

Test

Description of change

Anti-HAV, IgG

–          The previous assay detected all antibody isotypes (i.e., IgM and IgG), but the new assay only detects the IgG isotype.

–          The reporting comments have been updated to reflect this change.

–          Clinical utility of the assay remains unchanged.

Anti-HBs

–          Compared to the previous platform, antibody titers may vary due to differences in assay standardization.

–          There is no impact on test interpretation – antibody titers ≥ 10 IU/L continue to indicate immunity towards Hepatitis B infection.

Anti-HBc, Total

–          Accurate interpretation of Anti-HBc, Total requires consideration of Anti-HBs and HBsAg results. This recommendation is now provided as a comment with all test results.

Anti-HBe

–          No Change

HBeAg

–          No Change

HBsAg

–          No Change

Anti-HCV

–          No Change

Rubella, IgG

–          Compared to the previous platform, antibody titers may vary due to differences in assay standardization.

–          Interpretive comments have been updated to reflect this change:

o        Antibody titers > 10 IU/mL continue to indicate immunity towards Rubella.

o        Titers between 5.0 and 9.9 IU/mL may indicate low levels of Rubella-specific antibodies but would require clinical correlation (clinical symptoms, previous vaccination and/or exposure history) to assess immunity. This recommendation is provided with all reports that have a titer in this range.

o        Titers less than 5.0 IU/mL indicate no immunity towards Rubella.

Tests switching from the Abbott Architect i2000sr to the Abbott Alinity i platform

Anti-HAV, IgM

–          All specimens that test positive in the screening test will be reported as such and the sample will also be sent to Public Health Ontario Laboratories (PHOL) for confirmatory testing.

Anti-HBc, IgM

–          No Change

Method validations were performed for all the above tests at LifeLabs to ensure the assays meet our clinical requirements. A temporary notification will be included with all test results indicating a change in testing platform and highlighting any significant changes (as applicable and described in Table 1 above). This notification will be provided for 3 months. Please note, minor updates to interpretive comments for some of the tests will also be implemented to align with current clinical guidelines and improve interpretation of laboratory results.

We will continue to inform you as further replacements take place.

For any clinical or technical questions regarding this change please contact the following LifeLabs biochemists:

Uvaraj Uddayasankar, PhD FCACB

Clinical Biochemist                      

T   416-675-4530 Ext. 42211

E uvaraj.uddayasankar@LifeLabs.com

 

Kika Veljkovic (she/her) PhD FCACB

Discipline Head, High Volume Chemistry

T   416-675-4530 Ext. 42832

Kika.Veljkovic@LifeLabs.com

 

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