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

By LabMedica International staff writers
Posted on 12 May 2014

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.

Image: Vitamin D-Direct – the first direct vitamin D assay – no pretreatment, providing results in 20 minutes, with up to 400 tests/hour, on the CLC720 Chemistry Analyzer (Photo courtesy of Carolina Liquid Chemistries).

Image: The automated CLC720 Chemistry Analyzer provides discrete, efficient, and precise analysis, with multiple features including random access and 12 wavelengths (Photo courtesy of Carolina Liquid Chemistries).

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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Carolina Liquid Chemistries