First-of-its-Kind Vitamin-D Assay Provides Results in Minutes

An innovative assay kit provides the first direct test for Vitamin D, on the CLC720 analyzer, reducing labor and reagents, and providing a high-quality measurement in 20 minutes.

Carolina Liquid Chemistries Corp. (Winston-Salem, NC, USA) now provides "Vitamin D-Direct," the first direct—no pretreatment—Vitamin D test, currently available only on the automated CLC720 general chemistry analyzer. The company takes inefficient complex tests and develops user-friendly applications on clinical chemistry analyzers so that these tests can be performed at, or as close as currently possible to, point-of-care.

With this assay, the CLC720 analyzer can produce a Vitamin D result in 20 minutes without a technologist having to manually pretreat the specimen or the reagent. “The reality of a no-pretreatment Vitamin D-direct assay in minutes exemplifies innovation in clinical chemistry,” said Phil Shugart, president of Carolina Liquid Chemistries. The CLC720 analyzer can run up to 400 Vitamin D tests/hour, and can be run in random access mode with other chemistry tests, eliminating the need for batch testing. In comparison, microtiter plate Vitamin D tests are run in batch and require from 2 to 7 hours to complete.

Testing Vitamin D levels has become the cornerstone for the diagnosis and management of Vitamin D deficiency, which clinical studies have linked to pain, cancer, cardiovascular disease, diabetes, osteoporosis, multiple sclerosis, and Alzheimer’s disease.

Carolina Liquid Chemistries’ Vitamin D-Direct is an innovative homogenous immunoassay which measures the true total 25-Hydroxy Vitamin D. This new, FDA-cleared assay introduces a number of enhancements which include the following: a wide dynamic range with improved precision, elimination of time-consuming washing steps, and the elimination of inaccurate results caused by “matrix effects.” It correlates with LC/MS/MS, and has a 30-day on-board stability. The test is traceable to the newest standard reference material from the National Institute of Standards and Technology (NIST).

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