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Inoue K.,Kinjo Gakuin University | Dowell D.,AOAC INTERNATIONAL
Journal of AOAC International | Year: 2012

Official MethodSM 2011.21 is for the quantitation of the following nucleotides: adenosine 5'-monophosphate (AMP), guanosine 5'-monophosphate (GMP), uridine 5'-monophosphate (UMP), cytidine 5'-monophosphate (CMP), and inosine 5'-monophosphate (IMP) in infant formula and adult/pediatric nutritional formula. It uses hydrophilic interaction liquid chromatography with tandem mass spectrometry (HILIC-MS/MS). Preparation of the internal standards was conducted using centrifugal ultrafiltration and the standards are AMP-13C 10, 15N5; GMP-13C10, 15N5; UMP-13C9, 15N 2; and CMP-13C9, 15N3. Data were collected by using multiple reaction monitoring of the product ions of protonated molecules of the five nucleotides generated by positive-electrospray ionization. The HILIC conditions were conducted with ammonium formate (30 mmol/L) in water (pH 2.5, adjusted with formic acid) and methanol. The LOD and LOQ of the standard solution were 0.005-0.01 and 0.01-0.03 μg/mL, respectively. Recovery data were collected for intraday and interday testing and ranged from 98.1 to 108.9% with an RSD of 0.7-5.4%. The analytical range of the method is between 0.04 to 5 μg/mL for standard solution. © 2012 Publishing Technology.

News Article | February 28, 2017

Shimadzu Scientific Instruments, Inc. (Columbia, MD) and MIDI, Inc. (Newark, DE) have formed a strategic partnership to develop and market automated chromatographic solutions for agri-biotech, biodefense, dietary supplement, food science, forensics and renewable energy laboratories. These automated testing solutions will save analysis time and reduce labor costs, while providing unprecedented analytical accuracy over the “manual” chromatography approaches used in these industries. Under the terms of the agreement, Shimadzu is combining its 2010 GC, i-Series UHPLC, GCMS chromatography systems and LabSolutions™ software with MIDI, Inc.’s expert system software. Sherlock™ chromatography analysis software is a comprehensive and powerful data analysis platform, which precisely names compounds, performs complex pattern recognition and gives customers the ability to visually analyze their data in many different ways. Results are delivered automatically, reproducibly and objectively. The first product launch will be for automated microbial identification and soil phospholipid fatty acid (PLFA) analysis on Shimadzu’s 2010 GC product line, followed by solutions for the UHPLC and GCMS instruments. Gary Jackoway, MIDI Inc.'s Vice President and Director of Software Development, said, “We are delighted to partner with Shimadzu Scientific Instruments and have been impressed by their technology, team and customer support philosophy. This partnership will make automated and precise chromatography available to more customers than ever before and allow those customers to achieve maximum efficiency, reduce the learning curve and lower their labor costs.” “Shimadzu Scientific Instruments, Inc. is pleased to establish this important partnership. MIDI, Inc. has a long history of expertise in successfully automating and analyzing complex chromatographic data in growth markets. By combining their Sherlock™ software platform with state-of-the-art Shimadzu analytical instrumentation, along with our breadth of sales and support, we can offer even more customer-focused solutions,” said Mark Janeczko, Shimadzu Scientific Instruments, Inc. Marketing Manager. The Shimadzu and MIDI-integrated products will be exhibited at the 2017 Pittsburgh Conference and Expo - booth #4112. About Shimadzu Scientific Instruments, Inc. Established in 1975, Shimadzu Scientific Instruments (SSI), the American subsidiary of Shimadzu Corporation (Kyoto, Japan), provides a comprehensive range of analytical solutions to laboratories throughout North, Central, and parts of South America. SSI maintains a network of nine regional offices strategically located across the United States, with experienced technical specialists, service and sales engineers situated throughout the country, as well as applications laboratories on both coasts. For more information, please visit About MIDI, Inc. MIDI, Inc. is a private biotechnology company that specializes in automated and precise chromatography solutions. Founded in 1991, MIDI’s Sherlock™ software platform is used by scientists in more than 45 countries for automated analysis of: dietary supplements, fatty acids (FAME), fire debris, microbes, soil phospholipid fatty acids (PLFA) and spices. Sherlock™ has been US FDA 501(k) cleared for the identification of Bacillus anthracis (Anthrax pathogen) and Mycobacterium tuberculosis (TB pathogen). In addition, Sherlock™ is AOAC INTERNATIONAL cleared for Bacillus anthracis and US CDC-NIOSH cleared for aerobic bacterial identification. For more information, please visit

News Article | February 15, 2017

Charm Sciences, Inc. is pleased to announce the Charm TRIO test (TRIO) has received AOAC Performance Tested Methods (SM) (PTM) certification 121601. The Charm TRIO test detects beta-lactams, sulfonamide drugs, and tetracyclines in raw commingled milk at or below Canadian Maximum Residue Limits and US Tolerance/Target Levels in 3 minutes. “The TRIO test is the first multiplex assay validated by AOAC Research Institute (AOAC-RI) for three families of antibiotics,” said Bob Salter, Vice President of Regulatory Affairs for Charm Sciences. “The TRIO test is widely used in milk production, on farms, milk trucks, in dairy manufacturing, and in milk testing laboratories, due to speed, ease of use and broad detection ranges. Dairy stakeholders are increasingly interested in validating proper medicinal use in animal treatment and in assuring residue-free milk production beyond the most commonly used beta-lactam antibiotics. This validates a tool that casts a wider net in milk quality and production control that reduces time and complexity.” The Charm TRIO test is a lateral flow strip that detects three antibiotic families. It uses patented technology to target drug sensitivities at regulatory levels, which prevents unnecessary rejection of milk caused by overly sensitive screening tests. Results may be obtained using the Charm EZ system, an incubator and reader in one compact unit. Data can be transferred via Ethernet connection to network systems for full traceability with auto-alerts when positive loads are detected. About Charm Sciences, Inc. Charm Sciences is a world leader provider of food safety, water quality and environmental diagnostics. Charm’s diagnostics portfolio includes test kits and systems for antibiotics, mycotoxins, pesticides, alkaline phosphatase, microorganisms, end product microbial assessment, allergen control, water quality and ATP hygiene. Directly and through its network of distributors, Charm products serve the food, beverage, water, pharmaceutical, medical, personal care, environmental, and industrial markets in more than 100 countries. Customers rely on Charm products for excellence in quality, innovation and customer support. About AOAC-RI This method’s performance was reviewed by AOAC Research Institute and was found to perform to the manufacturer’s specifications. The AOAC Research Institute (AOAC-RI) was incorporated in 1991 as a wholly owned subsidiary of AOAC INTERNATIONAL. The AOAC-RI serves as an independent, third-party, nongovernment administrator of AOAC conformity assessment programs including the AOAC Performance Tested Methods(SM) (PTM) and Official Methods of Analysis(SM) (OMA) programs for alternative and sole source methods. For more information, visit

Vyas P.,Asure Quality Auckland Laboratory | O'Kane A.A.,Queen's University of Belfast | Dowell D.,AOAC International
Journal of AOAC International | Year: 2012

At the "Standards Development and International Harmonization: AOAC INTERNATIONAL Mid-Year Meeting" on June 29, 2011, an Expert Review Panel (ERP) agreed to further examine AOAC Official MethodSM 2011.01, "Determination of Vitamin B12 by Surface Plasmon Resonance," for use with infant formula and adult nutritionals. The original collaborative study was conducted using the Biacore Q TMbiosensor instrument and the Biacore QTM Qflex TM Kit Vitamin B12 Pl. Samples included in the study were infant formula, cereals, premixes, vitamin tablets, dietary supplements, and baby food. Eleven laboratories participated in the collaborative study. The results demonstrated a repeatability RSD (RSDr) of 1.59-27.8 and HorRat values for reproducibility of 0.34-1.89 in samples with levels ranging from ppm to ppb. The assay studied is a label-free protein binding-based assay that uses the principle of surface plasmon resonance to measure the interaction between vitamin B12 and a specific binding protein by passing a portion of the prepared sample extract combined with binding protein solution across a functionalized sensor chip. The response from the functionalized sensor chip is given as free-binding protein, as the mixture binds to the prepared surface of the chip. The ready-to-use Qflex Kit Vitamin B12 PI provides the reagents and accessories necessary to perform this assay. AOAC Method 2011.01 was approved by the AOAC Method Committee on Food Nutrition for Official First Action status, applicable to a wide range of food products, dietary supplements, and multivitamin premixes. After evaluation of the validation data available, an ERP agreed in June 2011 that the method meets standard method performance requirements, as articulated by the Stakeholder Panel on Infant Formula and Adult Nutritionals. The ERP granted the method First Action status, applicable to infant formula and adult/pediatric nutritional formula. © 2012 Publishing Technology.

Wehling P.,General Mills Inc. | LaBudde R.A.,Least Cost Formulations Ltd. | Brunelle S.L.,AOAC INTERNATIONAL | Nelson M.T.,AOAC INTERNATIONAL
Journal of AOAC International | Year: 2011

A statistical model is presented for use in validation of qualitative methods. This model, termed Probability of Detection (POD), harmonizes the statistical concepts and parameters between quantitative and qualitative method validation. POD characterizes method response with respect to concentration as a continuous variable. The POD model provides a tool for graphical representation of response curves for qualitative methods. In addition, the model allows comparisons between candidate and reference methods, and provides calculations of repeatability, reproducibility, and laboratory effects from collaborative study data. Single laboratory study and collaborative study examples are given.

The method for the "Determination of Vitamins D2 and D 3 in Infant Formula and Adult Nutritionals by Ultra-Pressure Liquid Chromatography with Tandem Mass Spectrometry Detection (UPLC-MS/MS)" was adopted as AOAC Official First Action during the "Standards Development and International Harmonization: AOAC INTERNATIONAL Mid-Year Meeting" held June 29, 2011. During the meeting, an Expert Review Panel (ERP) evaluated the available validation information against standard method performance requirements (SMPRs) articulated by stakeholders. The method, approved by the ERP, is applicable for the determination of vitamin D (total vitamins D 2 and D3). A range of products had been tested during a single-laboratory validation study. The products included butter, National Institute of Standards and Technology SRM 1849, eggs, cheese, yogurt, ready-to-eat cereal, bread, mushrooms, and tuna. The testing of the method established linearity in the range of 0.005-50 μg/mL. The recovery range was 93.4-100.9% for vitamin D2 and 102.4-106.2% for vitamin D 3. The LOD and LOQ for vitamin D2 were reported as 0.20 and 0.61 μg/100 g, respectively; for vitamin D3, the reported values were 0.47 and 1.44 μg/100 g, respectively. The method met the SMPRs set by the Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN). It was, therefore, decided that the method was appropriate for Official First Action Method status. © 2012 Publishing Technology.

Pacquette L.H.,Abbott Laboratories | Levenson A.M.,Abbott Laboratories | Thompson J.J.,Abbott Laboratories | Dowell D.,AOAC International
Journal of AOAC International | Year: 2013

After an assessment of data generated from a single-laboratory validation study published in the Journal of AOAC InternAtIOnAl 95, 169-176(2012), a method for determining the total level of iodine in infant formula and nutritional products was presented for consideration for adoption by AOAC during the AOAC Annual Meeting held September 30-October 3, 2012 in Las Vegas, NV. An Expert Review Panel on Infant Formula and Adult Nutritionals concluded that the method met the established standard method performance requirements, and approved the method as AOAC Official First Action. The method involves digestion of the sample with nitric acid in a closed vessel microwave oven, followed by determination by inductively coupled plasma/MS using tellurium as the internal standard. The method LOQ for total iodine was 1.5 μg/100 g, but a practical LOQ was used at 5 μg/100 g total iodine. The analytical range of the method was 5-100 μg/100 g total iodine. The recoveries from 15 spiked nutritional products ranged from 90 to 105%.

Schimpf K.,Abbott Laboratories | Thompson L.,Abbott Laboratories | Baugh S.,AOAC INTERNATIONAL
Journal of AOAC International | Year: 2012

Myo-inositol is a 6-carbon cyclic polyalcohol also known as meso-inositol, meat sugar, inosite, and i-inositol. It occurs in nature in both free (myo-inositol) and bound (inositol phosphates and phosphatidylinositol) forms. For the determination of free myo-inositol, samples are mixed with dilute hydrochloric acid to extract myo-inositol and precipitate proteins, diluted with water, and filtered. For the determination of myo-inositol bound as phosphatidylinositol, samples are extracted with chloroform, isolated from other fats with silica SPE cartridges, and hydrolyzed with concentrated acid to free myo-inositol. Prepared samples are first injected onto a Dionex CarboPac PA1 column, which separates myo-inositol from other late-eluting carbohydrates. After column switching, myo-inositol is further separated on a CarboPac MA1 column using a 0.12% sodium hydroxide mobile phase; strongly retained carbohydrates are eluted from the PA1 column with a 3% sodium hydroxide mobile phase. Eluant from the CarboPac MA1 analytical column passes through an electrochemical detector cell where myo-inositol is detected by pulsed amperometry using a gold electrode. The method showed appropriate performance characteristics versus selected established standard method performance requirement parameters for the determination of myo-inositol: linear response; repeatability (RSDr) of 2%; and intermediate precision (RSDir) of 2.5%. Instrument LOD and LOQ were 0.0004 and 0.0013 mg/100 mL, respectively, and correspond to a free myo-inositol quantitation limit of 0.026 mg/100 g and a phosphatidylinositol quantitation limit of 0.016 mg/100 g. Correlation with the reference microbiological assay was good. The proposed method has been accepted by the Expert Review Panel as an AOAC First Action Method, suitable for the routine determination of myo-inositol in infant formula and adult nutritionals.

Accreditation and Quality Assurance | Year: 2011

AOAC INTERNATIONAL has developed a process to set Standard Method Performance Requirements (SMPRs). The fitness for intended use of the result of the measurement determines the criteria for these requirements. These criteria are specified by the stakeholder panels made up of key experts from global government, industry, academia, and contract research organizations. This process has been implemented for assays aiming at the detection of bio-threat agents, endocrine disruptors, and quantifying nutrients in infant formula. The process begins with the formation of a balanced stakeholder panel. The stakeholder panel specifies analytes, matrices, current technologies, analytical challenges, and regulatory information at the first meeting. Working groups are formed to provide specific technical expertise to the stakeholder panels. These groups perform the task of translating the specified needs of the stakeholder panel into concise measurement requirements. The draft SMPRs go back to the stakeholder panel for review and approval and then are posted for comment on the AOAC web site. These requirements become consensus requirements that have been developed with openness, balance of interests, an appeals procedure, consensus, and transparency. © 2011 Springer-Verlag.

Pacquette L.H.,Abbott Laboratories | Szabo A.,Abbott Laboratories | Thompson J.J.,Abbott Laboratories | Baugh S.,AOAC INTERNATIONAL
Journal of AOAC International | Year: 2012

An inductively coupled plasma/MS method was developed for the simultaneous determination of Cr, Se, and Mo in infant formula and other nutritional products. All samples were digested using a closed vessel microwave oven system, together with Ni and Te internal standards. The practical quantitation limits for Cr, Se, and Mo were 0.4, 0.2, and 0.4 ng/mL, respectively; dilution factors were 250 for powders and 50 for liquids. The Cr, Se, and Mo concentrations in 10 nutritional products were within specification limits; within-day and day-to-day (6 independent days) precision values were <5% RSD. For two control samples, the observed precision was =2% RSD over 10 independent days. Cr, Se, and Mo results were within the certified limits in three National Institute of Standards and Technology standard reference materials. The average sample spike recoveries for 10 nutritional products ranged from 93 to 107%. Robustness studies showed a minimal effect from concomitant easily ionized element concentrations. However, the choice of internal standard and matrix-matching carbon content were critical to obtaining accurate Se results. All indications are that this method would be a suitable candidate as a global reference method for the determination of these trace elements in infant formula, adult nutritionals, and other nutritional products. © 2012 Publishing Technology.

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