Endocrine Abstracts

The Waters MassTrak Vitamin D Kit is designed for the quantitative determination of serum or plasma 25-hydroxyvitamin D3 (25OHD3) and 25-hydroxyvitamin D2 (25OHD2), which in combination provide the total 25-hydroxyvitamin D concentration as an aid in the assessment of vitamin D sufficiency.

The MassTrak Vitamin D Kit is validated for use with the Waters® ACQUITY UPLC® I-Class/Xevo® TQD IVD System and the sample preparation has been validated using the Tecan® Freedom 100/4 EVO® Offline Automated Liquid Handling system. Screening for vitamin D deficiency is recommended by the Endocrine Society Clinical Guidelines- Evaluation, Treatment and Prevention of Vitamin D Deficiency by the Task Force for all individuals at risk for deficiency.

Vitamin D status (Total 25OHD, which is the sum of 25OHD2 and 25OHD3) has been a challenge to measure accurately because the antibodies used in many immunoassays do not have 100% co-specificity for both 25OHD2 and 25OHD3.

Precision, sensitivity, linearity, potential interferents and carryover were all assessed during the development of the MassTrak™ Vitamin D kit and found to meet the performance criteria specified for the kit.

To further assess the accuracy and performance of the MassTrak™ Vitamin D kit assay, Waters enrolled in the CDC Vitamin D Standardisation Certification Program (VDSCP) for 25(OH)D in serum, which assesses bias and precision of assays relative to reference measurement procedures.

The MassTrak™ Vitamin D kit calibrator materials are traceable to NIST SRM2972a via a documented unbroken chain of calibrations. The accuracy of this traceability to NIST SRM2972 has been verified through participation of the Vitamin D Standardisation Certification Program (VDSCP).