On March 3, 2021, the BC Provincial Laboratory Medicine Services released an information bulletin stating that some lab results for markers of kidney function have been affected by production issues with analytical reagents. Some serum creatinine measurements (SCr) may show higher than expected results, and calculated glomerular filtration rate values (eGFR) may be lower than expected
The shift towards higher SCr values is associated with some batches of reagents used in Roche chemistry analyzers for serum creatinine. This problem has been reported internationally. In BC, the affected sites are LifeLabs, Valley Medical Laboratories, and some Northern Health laboratories. The upward shift in SCr results affects samples drawn in November 2020 to March 2021.
Affected laboratories have posted additional information on their websites and/or have added interpretation notes to affected test results, and are communicating with healthcare providers. For information updates:
- To view the BC Provincial Laboratory Medicine Services bulletin, click here. (Updated March 15, 2021)
- To view BC LifeLabs notification and alert updates, click here.
- To view Valley Medical Laboratories news updates, click here.
Note that a variety of analytical systems are employed by BC laboratories, and this issue only affects the Roche serum creatinine assay (not the plasma creatinine assay).
Implications for antiretroviral safety monitoring:
- Use caution when making renal dose adjustments to antiretroviral medications (e.g. lamivudine, tenofovir DF). Excessive dose reduction based on a falsely low eGFR result could result in inadvertent under-dosing.
- When monitoring kidney function, be aware that affected laboratories may report SCr values an average of 9 μmol/L higher than previous samples, and corresponding eGFR values may be an average of 8 mL/min/1.73 m2 lower. Consider the overall clinical picture and results of serial monitoring.
Update: The affected laboratories advised that the issue with the manufacturer’s serum creatinine reagent was resolved in mid-March 2021.