North American Instruments, Inc.
The Calais Human Milk Analyzer is FOR INVESTIGATIONAL USE ONLY. The performance characteristics of the product have not been established.
The Calais Story
Elena Medo, Founder & CEO
The story of the Calais Analyzer began shortly after I developed and commercialized the first human milk fortifier made from human milk. Trying to fortify mother's milk to an unknown base was an impossible task and I wanted to help neonatal staff overcome this challenge. Neonatologists, nurses and nutritionists working with preterm babies have known for a long time that babies thrive when given a diet of exclusively human milk. Recent published research has further amplified that fact. But, because very small preterm babies need more protein than mother's milk provides, fortification is often required. The amount of protein in mother's milk fluctuates, adding to the difficulty of achieving accurate fortification without analysis. Too little protein may result in sub-optimal growth and brain development, while too much protein may trigger mild protein shock and intolerance.
Recognizing the need for clinical human milk analysis, I founded North American Instruments to find a solution to this vexing problem.
Prior to developing the Calais Analyzer, we searched the world for an instrument that would work for this application. I had purchased a midrange analyzer for my previous company, but it was designed for dairy milk and the reference methods and calibration sets had never been optimized for human milk. All other instruments I found were available were either designed for dairy use or laboratory use. Having worked with neonatal units for over 25 years, I had a very good understanding of what type of instrument was needed. Accuracy, precision and ease of use were our biggest priorities, yet none of the instruments available performed up to the standards we required. Human milk differs substantially from cow's milk so it was vital to use internationally recognized standards for milk analysis and to provide reference methods, calibration and control samples to assure the highest level of accuracy and precision based on optimized wet bench reference methods.
Analyzers fall into 3 categories, using 3 different methods:
Mid infrared Range
Near infrared Range
We met with manufacturers in Europe, Asia and North America and looked at analyzers utilizing all three methods above. Our goal was to find something that offered a validated quality standard because the neonatal intensive care unit is not a place to experiment with unproven analytical methods. We also wanted to bring a unit that was easy to use, avoiding preliminary steps such as homogenization and heating of the sample.
We quickly discovered that there was nothing available off the shelf that would be appropriate. We knew that we would need to co-develop this instrument with a leading, high quality manufacturer. We felt it was important to have technical support available here in this country instead of trying to adapt for foreign languages and large time zone differences. We briefly considered laboratory instruments using NIR (near infrared analysis) but decided against this method because 1) NIR is not a validated method for milk, 2) the unit does not heat and homogenize the milk sample, those steps would have to be done separately, 3) the sample would need to be within a half degree C to avoid an error result, 4) the potential for lower cost did not offset the disadvantages.
We soon found that David Anderson of Metron Instruments in Cleveland, Ohio shared our passion for the well-being of preterm babies and had a great reputation for high quality and excellent technical service. During the next 18 months, we worked together to implement modifications on existing dairy analyzers and to optimize reference methods for human milk so that we could better serve the needs of neonatal critical care units. After speaking with dozens of hospital quality professions we found that our focus on quality standards was also very important to them. Wanting to bring the most accurate and precise method to NICUs, we adopted the only method that meets the international standard set by the AOAC for milk analysis, which is mid-range infrared spectroscopy (MIR). We felt that the application in neonatal units demanded that we provide only the best, most accurate unit and since MIR is the only method validated by the AOAC, it was an easy decision to make.
We delivered our first analyzer to a major medical center in 2009 and worked with them over the next 18 months to optimize its use in a busy clinical environment. Streamlined methods for periodic calibration plus the development of Calais control samples have resulted in a high level of user confidence in the accuracy and precision of the instrument.
In August 2011, North American Instruments and Metron Instruments celebrated our third anniversary as partners. We look forward to many more. We are proud that the Calais Analyzer is now the subject of numerous research projects in major intensive care units and data is forthcoming. We're happy to share all that we've learned about human milk analysis so take a few minutes and review the material we provide.
All over the world, there are barriers that still exist, preventing or minimizing the use of human milk in critical care units. This Company's mission is to design innovative solutions to remove those barriers, increasing access to breast milk for hospitalized babies and children.
For 27 years, I have worked to help improve access to human milk in hundreds of the nation's top neonatal intensive care units. My longstanding relationships at these hospitals demand that we deliver only the best and that we stand firmly behind our product. We're proud of our contribution to the quality of nutritional care for preterm babies and we hope you will consider implementing human milk analysis in your neonatal unit, initially as part of a research project and later, as part of your standardized care. In the meantime, stay tuned for more solutions to your human milk handling challenges. We're not finished yet.
Contact Us at (971) 322-4311 or email us at: info at calaisanalyzer dot com