Quantimetrix, Redondo Beach, Calif, recently released the new Complete D 25-OH Vitamin D Control-an FDA-cleared, ready-to-use liquid control. CLP recently spoke with Andrew Schaeffer, senior R&D scientist at the company, to learn more about it.

CLP: Why did Quantimetrix develop the new Complete D 25-OH Vitamin D Control?

Schaeffer: The decision was driven by the explosive growth in the volume of vitamin D testing being performed in clinical laboratories worldwide. The growth in testing has created a clear need for FDA-approved third-party control materials. Our product meets that need.

CLP: What does it monitor?

Schaeffer: The control was approved in the United States to monitor the performance of clinical assays used to quantitate total 25-OH Vitamin D. For international customers, it may be used to monitor the performance of assays distinguishing the 25-OH D2 and D3 forms of Vitamin D as well.

CLP: What test or marker is the control designed to be used with?

Schaeffer: For the US market, the analyte is total 25-OH Vitamin D. For international customers, values are provided for total 25-OH Vitamin D, as well as 25-OH D2 and D3.

CLP: What instruments is this control designed to be used on?

Schaeffer: The insert has ranges for the following methods; LC-MS-MS systems, with separate values for laboratories using JCTLM reference methods C8RMP3 and C8RMP4, Diasorin Liaison, IDS-EIA, and IDS-RIA. We will have additional assays on our insert soon.

CLP: What type of specimen/sample is used?

Schaeffer: Because these assays are all performed using serum samples, our control is formulated using a human serum matrix.

CLP: What is the time to result under optimal conditions and how are the results made available?

Schaeffer: Because this is a control product, it will vary based on the analytical system.

CLP: Is there anything else you would like to add?

Schaeffer: Our control is liquid and requires no reconstitution, making it easy to use. It also has an open-vial shelf life of 1 year at 2 to 8 C and 30 days at room temperature (18 to 25 C). The control values are traceable to NIST standard SRM 972.