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Creatinine Reagent Lot Positive Bias – Resolution

March 18 2021
On March 3rd 2021, LifeLabs sent a memo to all clients informing them of a positive bias on the serum creatinine assay, causing a positive shift of up to 8 umol/L in creatinine results, along with the concurrent negative shift in eGFR. The root cause was the manufacturer reagent lot bias. An interpretive comment was added to all serum creatinine results at that time, to inform clients of the shift, while LifeLabs worked on resolution. A new reagent lot has been made available recently, and LifeLabs validation has confirmed that it corrects the previously introduced bias. This lot is implemented at all LifeLabs laboratory sites as of March 18, 2021.

On March 3rd 2021, LifeLabs sent a memo to all clients informing them of a positive bias on the serum creatinine assay, causing a positive shift of up to 8 umol/L in creatinine results, along with the concurrent negative shift in eGFR. The root cause was the manufacturer reagent lot bias. An interpretive comment was added to all serum creatinine results at that time, to inform clients of the shift, while LifeLabs worked on resolution.

A new reagent lot has been made available recently, and LifeLabs validation has confirmed that it corrects the previously introduced bias. This lot is implemented at all LifeLabs laboratory sites as of March 18, 2021.

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Creatinine Reagent Lot Positive Bias.

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