Manufacturing
SciMed Technologies is committed to providing a high quality product to its customers. To this end, every VitaKit™ is manufactured in a cGMP and ISO 13485 certified facility.
Internal Validation – Blind Test Results
Comparison of Methodology: Vitakit™ A & D vs Accepted HPLC methods
Introduction
The current standard for vitamin A & D determination is via HPLC, with an accepted variance in the results of 50-150% of the target value. The goal of this study is to ascertain whether the VitaKits™ are statistically comparable to the HPLC standard, i.e., fall in the range of 50-150% of target value In order to complete this study, commercial milk samples were purchased, and tested for vitamin content using the currently accepted HPLC methodology and the new ELISA-based methodology of the VitaKit™.
Summary of Validation Protocol
Methods Used
- HPLC determination of Vitamin A followed the AOAC Official Methods 992.04, 992.06, 2002.06, or an analogue thereof.
- HPLC determination of Vitamin D followed the AOAC Official Method 981.17 or an analogue thereof.
- ELISA determination of Vitamin A & D followed the methods developed by SciMed, and was included in the package inserts.
Test Protocol
In order to complete the test, seven clients spread over three continents were selected for Vitamin A and eight clients for Vitamin D. In a blind study, commercial milk samples were purchased and sub divided for HPLC and ELISA analysis by the clients. VitaKits™ were supplied to the clients by SciMed. An effort was made to select equal numbers of different milk-fat content products to demonstrate the flexibility and consistency of the VitaKit™. HPLC and ELISA results were performed simultaneously. Results from the trial were pooled and tabulated.
Results
Testing has been performed following the above protocol to compare the VitaKits™ to the current HPLC methods of analysis. 41 Vitamin A and 44 Vitamin D samples were tested, and the mean values calculated:
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The data shows that ELISA-based VitaKits™ are within a 3% variance with the HPLC for Vitamin A and a 1.5% variance for Vitamin D. These values are well within the acceptance ranges of variation for HPLC as specified by FDA (50 – 150 %).
Conclusion
The data indicates that the VitaKit™ method is comparable to the established HPLC methods, and may provide a feasible alternative to the HPLC methods.