Cedars-Sinai Medical Center

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CME Newsletter - December 2016 (PDF)  


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Core Labs to Switch to STAT Immunoassay Dec. 21

The Core laboratories in the Department of Pathology and Laboratory Medicine will switch from a standard PTH immunoassay to a STAT immunoassay beginning Wednesday, Dec. 21.

The new STAT PTH assay from Roche Diagnostics will have an incubation time of about nine minutes, approximately half the current time. This shorter test will particularly benefit intraoperative PTH measurement, where patients are held in surgery under anesthesia to ensure sufficient parathyroid tissue has been removed during parathyroidectomy.

There is a large negative bias with the new Roche assay (compared to the existing Abbott assay) of 33 percent. Many immunoassays are not standardized to a reference method or to each other, so biases between manufacturers are to be expected.

Since the new STAT PTH assay will be used for routine PTH measurement, in addition to intraoperative assessment, it is important to note this difference once live. Reference intervals will also be adjusted in accordance with a validation of Roche expected values.

Please see below:

Abbott (current method) Roche (new method)
Bias -33% (lower)
Reference Interval 8.7 – 77.1 pg/mL 15.0 – 65.0 pg/mL

When new STAT PTH assay begins use, a comment will also be appended to all new results noting the bias. This comment will be present for 90 days.

If you have questions, please contact Kimia Sobhani, PhD, at kimia.sobhani@cshs.org, or Holli Mason, MD, at holli.mason@cshs.org.