Vitamin D-direct™ from Carolina Liquid Chemistries Corp. receives “Moderate Complexity” Categorization by the FDA

Carolina Liquid Chemistries Corp. announced today that its “Vitamin D-direct™” test has received a “Moderate Complexity” categorization by the Food and Drug Administration (FDA). The Moderate categorization makes it easier for physicians to test patient samples for Vitamin D, reducing the cost of care.

“Our direct Vitamin D test runs in 20 minutes without the need to pre-treat the sample or reagent,” says Chief Operating Officer Patricia Shugart. The speed and ease of Vitamin D-direct™ is made possible by the company’s CLC720 chemistry analyzer which, unlike most anlyzers in its class, automates steps that would otherwise have to be performed manually.

The CLC720 can run up to 400 Vitamin D tests per hour, and it 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. Carolina Liquid Chemistries’ direct Vitamin D test is an innovative homogenous immunoassay which measures the true total 25-Hydroxy Vitamin D (sum of both D3 + D2). This new, FDA-cleared, moderate complexity 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.” The test is traceable to the newest standard reference material from the National Institute of Standards and Technology (NIST).

Vitamin D testing has increased due to recent clinical studies on Vitamin D deficiency, which has been linked to conditions such as psoriasis, asthma, arthritis, diabetes, rickets, thyroid conditions, chronic pain, osteoporosis, cancer, multiple sclerosis, and Alzheimer’s disease. Testing Vitamin D levels has become the cornerstone for the diagnosis and management of Vitamin D deficiency.

Carolina Liquid Chemistries Corp. is an ISO certified and FDA regulated repackager/relabeler of chemistry systems. The company specializes in innovative reagent technologies, taking inefficient complex tests and developing user friendly applications on clinical chemistry analyzers, so that these tests can be performed in physicians’ offices. Carolina Liquid Chemistries offers a broad range of chemistry analyzers from moderate throughput bench top analyzers to ultra high speed floor models, along with the reagents and service to support the instrumentation.