Dear health care providers,
We are pleased to share an update on the replacement of Roche Cobas and Abbott Architect analyzers used nationally at LifeLabs. At LifeLabs sites in Ontario, the testing performed on these analyzers includes clinical chemistry assays, immunoassays, and infectious disease (serology) assays. We are moving to the Abbott Alinity testing platform for these assays.
The first and second phase of this process took place between August 2022 and February 2023, with the move of Hepatitis and Rubella serology tests, and high-volume immunoassay tests to the new Abbott Alinity i platform. Please refer to the previous communication (July 2022 and September 2022) for details. In the third phase, all of core chemistry and therapeutic drug monitoring (TDM) tests will transition to the Abbott Alinity c platform. This will take place gradually, starting on May 28th 2023 for the tests performed at the Sudbury and Thunder Bay sites, followed by June 11th 2023 for the tests performed at Belleville testing site. Tables 1 and 2 below list the chemistry and TDM tests, respectively, which will require reporting changes on the new platform at that time. Further changes will occur with the platform transition at the Toronto and Mississauga LifeLabs testing sites later this year, and they will be communicated prior to implementation at these sites. The remaining tests not listed in this notice, will not require changes upon transition.
As per our quality standards, method validations were performed for all assays at LifeLabs to ensure the assays meet our clinical and analytical performance requirements.
Importantly, reporting of lipid tests will be updated to align with the most recent Canadian guidelines and recommendations.1-3 These changes include updates to decision limits/thresholds as listed in Table 3 below, and a new (NIH) equation to calculate Low-Density Lipoprotein Cholesterol (LDL-C) for adults and children. LDL-C, a calculated test, has been reported using the Friedewald equation. The Friedewald equation has several limitations: it is not accurate when triglycerides are > 4.52 mmol/L, and when LDL-C is < 1.50 mmol/L. The new NIH equation4, validated in the Canadian population5 and verified using LifeLabs internal data, is more accurate when triglycerides are high (between 4.52 and 9.04 mmol/L) and when LDL-C is low (between 0.50 and 1.50 mmol/L). This enables improved monitoring of patients on new lipid lowering therapies.
A notification will be included with all test results for 3 months indicating a change in testing platform and highlighting any other significant changes (as applicable and described in Tables 1-3 below). For any clinical or technical questions regarding this change please contact the following LifeLabs biochemists:
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Dr. Kika Veljkovic, PhD FCACB Discipline Head, High Volume Chemistry T 416-675-4530 Ext. 42832 |
Dr. Mohamed Abouelhassan PhD FCACB Clinical Biochemist T 416-675-4530 Ext. 42216 E mohamed.abouelhassan@lifelabs.com
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Thank you,
Dr. Catherine Ross, MD, MSc, FRCPC
Medical Director, ON
T 647-943-2413 Ext: 42980
Table 1. Clinical chemistry tests that are undergoing changes with the transfer to Abbott Alinity c platform:
|
Test |
Description of test change |
|
Albumin (Urine) |
Reported values may show up to 15% increase compared to the previous method. Reference intervals are unchanged. |
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Aspartate Aminotransferase (AST) |
Reported values may show up to 14% increase compared to the previous method. Reference intervals are unchanged. |
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Bicarbonate (CO2) |
Test name changed to Carbon Dioxide to align with other laboratories. |
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Chloride (Serum) |
Reference interval has been adjusted as a result of the transfer to the new Abbott Alinity c platform. |
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Gamma-Glutamyl Transferase (GGT) |
Reference intervals have been adjusted as a result of the transfer to the new Abbott Alinity c platform. |
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Lipase |
Reported values may show up to 13% decrease compared to the previous platform. Reference intervals are unchanged. |
Table 2. TDM tests that are undergoing changes with the transfer to Abbott Alinity c platform:
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Lithium |
Therapeutic ranges have been updated to reflect recent guidelines. |
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Table 3. Summary of the Reporting Changes for Lipid Tests:
|
Test |
Adult (≥ 20years old) decision limits (mmol/L)1,3 |
Pediatric (< 20 years old) decision limits (mmol/L)2 |
|
LDL-C |
<3.50 Decision limits and interpretative comments are consistent with recommendations for the management of dyslipidemia in adults with intermediate risk (Framingham Risk Score 11-19%)1,3 |
Desired: :<2.80 Borderline: 2.80-<3.40 Increased risk: ≥3.40 |
|
Non-HDL-C |
<4.20 Decision limits and interpretative comments are consistent with recommendations for the management of dyslipidemia in adults with intermediate risk (Framingham Risk Score 11-19%)1,3 |
Desired: <3.10 Borderline: 3.10 to < 3.75 Increased risk: ≥ 3.75 |
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Total Cholesterol |
<5.20 |
Desired: <4.40 Borderline: 4.40 to 5.10 Increased Risk: ≥ 5.20 |
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HDL-C |
Males: ≥1.00 Females: ≥1.30 |
Desired: >1.20 Borderline: 1.00 to 1.20 Increased risk: < 1.00 |
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Triglycerides |
Fasting: <1.70 Non-fasting: <2.00 |
0-9 years old: Fasting: Desired: <0.80 Borderline: 0.80 to <1.10 Increased risk: ≥ 1.10 Non-fasting: Desired: <1.00 Borderline: 1.00 to <1.30 Increased risk: ≥ 1.30 10-19 years old: Fasting: Desired: <1.00 Borderline:1.00 to <1.50 Increased risk: ≥ 1.50 Non-fasting: Desired: <1.20 Borderline: 1.20 to <1.80 Increased risk: ≥ 1.80 |
REFERENCES:
- Pearson GJ, Thanassoulis G, Anderson TJ, et al. 2021 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in Adults. Can J Cardiol. 2021;37(8):1129-1150.
- Khoury M, Bigras JL, Cummings EA, et al. The Detection, Evaluation, and Management of Dyslipidemia in Children and Adolescents: A Canadian Cardiovascular Society/Canadian Pediatric Cardiology Association Clinical Practice Update. Can J Cardiol. 2022;38(8):1168-1179.
- White-Al Habeeb N & Higgins V, et al. Harmonized Lipid Reporting for Clinical Laboratories based on the 2021 Canadian Lipid Guidelines. Can J Cardiol. 2022;38(8)1180-1188.
- Sampson M, et al. A new equation for calculation of low-density lipoprotein cholesterol in patients with normolipidemia and/or hypertriglyceridemia. JAMA Cardiology 2020;5(5):540-548.
- Higgins V, et al. Validating the NIH LDL-C equation in a specialized lipid cohort: Does it add up? Clin Biochem. 2022;99:60-68.
