has announced that its LC-MS/MS method for the analysis of Vitamin D in infant formula has been granted “Official First Action” status as an Official Method by AOAC International (AOAC).
This, said the company, makes the Covance testing method the international “dispute resolution” test for infant formula, an agreed-upon standard for resolving conflicting test results. It also means that labs across the globe will adopt the Covance method.
AOAC is the Association of Analytical Communities, an international, not-for-profit scientific association that provides independent assessment of food nutrition and safety testing methods. To meet these goals, AOAC has two methods validation programs; the AOAC Official Methods Program and the AOAC Performance Tested Methods Program.
“Having a method that is accepted across multiple countries and regulatory bodies is significant, especially for international food manufacturers, who don’t want to have to go through multiple types of testing to sell globally,” said Doug Winters, executive director, science and technology, Covance Nutritional Chemistry & Food Safety. “We are proud that the Covance method was selected to be the industry standard.”
AOAC initiated a review of infant formula testing methods as a result of significant changes in the industry since the group’s last evaluation in the 1980s.
“Infant formula produced today is far superior, with novel new ingredients, more stability and increased bioavailability,” said Darryl Sullivan, director of scientific and regulatory affairs. “AOAC wanted to be sure that testing methods were keeping pace with the industry’s innovation.”
The Covance method was one of more than a dozen studied by international scientists on the AOAC’s Stakeholder Panel on Infant Formula and Adult Nutritionals. The panel drafted a set of requirements all Vitamin D testing methods had to meet before even being considered for evaluation. Those methods that met this standard were put through rigorous single laboratory validation studies where they were assessed for precision, accuracy, specificity, practicality and a series of other attributes.
“The panel was looking for a standard method that met all the requirements, but was also ‘rugged’ enough to be easily used across many different manufacturers, formulas and countries,” said Sullivan. “The Covance method came out on top.”
Covance has been involved in the testing of Vitamin D for more than 80 years. The company pioneered a bioassay in the 1930s, when Vitamin D first began being added to milk. Today’s LC-MS/MS method for Vitamin D is, according to the company, another innovation. Also known as a ‘triple-quad mass spec’, LC-MS/MS has been used by the pharmaceutical industry for 20 years. Covance says that it was one of the first to apply it to nutritional testing. The company took four years to apply and refine this technology to the analysis of Vitamin D, not only in infant formula, but in a wide range of food and dietary supplement matrices.
“This method is a lot more straightforward than previous tests, simplifying many of the sample preparation steps. It’s more selective and tests for multiple forms of Vitamin D, including D2 and D3,” said Winters. “While Vitamin D is an essential nutrient, over-fortification of Vitamin D can be lethal, so accurate measurement is critical. This test produces data more quickly, it’s simpler and more accurate – and now it’s available for labs across the world to use.”
The Covance method will now be adopted by hundreds of labs across the globe. Data from these tests will be evaluated to move the method to AOAC Official Final Action Status, expected within the next two years.
