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Instructions for hygiena models including: KIT4001, KIT4001 RapiScreen Dairy 5000 Kit, RapiScreen Dairy 5000 Kit, Dairy 5000 Kit, 5000 Kit
Innovate™ Autosampler III | Hygiena
Innovate™ | Hygiena
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DocumentDocumentRapiScreenTM Dairy 5000 Kit For Hygiena's InnovateTM Rapid Microbial Screening System Product No. KIT4001 (5,000 tests) Introduction Description and Intended Use Hygiena's RapiScreenTM Dairy Kit, along with the InnovateTM System luminometer and InnovateTM software, provides a rapid screening method to confirm the absence of microbial contamination in long-life dairy, nondairy and similar shelf-stable products. The presence/absence of microorganisms is determined by using ATP bioluminescence technology. The system is intended for use by trained operators. Kit Components of the RapiScreen Dairy Kit (5,000 tests) Kit Configuration Sensilux Dilutor DS Cellsolver DE ATX Dilutor DA Microwash Polypropylene (PP) vials Microplates, 96-well 5,000-Test Kit 25 x 200 test vials 1 x 370 mL bottle 2 x 185 mL bottles 25 x 200 test vials 1 x 370 mL bottle 2 x 400 mL bottles 10 x 50 mL vials 60 plates Test Procedure Getting Started 1. Remove one vial of each reagent from storage at 2 to 8 °C, and allow reagents to warm to room temperature before reconstitution. Note: To avoid contamination, wear gloves when opening glass vials. 2. Carefully open a vial of Sensilux (yellow cap) and dispense 14 mL of Dilutor DS into the vial. Swirl gently to mix and pour the total contents into a 50 mL PP vial. Do not shake. 3. Carefully open a vial of ATX (red cap) and dispense 14 mL of Dilutor DA into the vial. Swirl gently to mix and pour the total contents into a second 50 mL PP vial. 4. The Cellsolver DE and Microwash are ready for use. 5. Place the reagents in the Innovate System reagent holder cooling unit and leave for 15 minutes before use. 6. Prime the Innovate System luminometer with the prepared reagents. www.hygiena.com 1 INS-KIT4001-REVB Protocol 1. Incubate the sample in its original packaging (or separate container) at 30 °C (or other validated temperature) for a minimum of 48 hours. Note: The typical incubation time for UHT dairy products is 24 72 hours. All users should determine the most appropriate sample preparation, incubation times and temperatures based on their product types and microorganisms of interest. 2. Following incubation, shake the sample to ensure any contamination is well-mixed. 3. Pipette 50 L of the sample into a well of the microtiter plate. 4. Place the microtiter plate in the luminometer and run the appropriate protocol. The light emitted is then measured and recorded in Relative Light Units (RLUs). Refer to the Innovate System Operator Manual for full instructions on the programming and operation of your instrument. Additional Information Controls It is recommended to run an instrument blank, reagent blank and ATP positive control daily to ensure the system is functioning properly. Interpretation of Results Compare the RLU values to the product RLU threshold and determine the pass/fail status of each sample. Refer to the Innovate System Implementation Guide or contact your Hygiena® Technical Support Representative to determine how the RLU readings should be interpreted. Positive results should be further confirmed and identified according to the user-defined microbiology methods for contamination investigations. AOAC RI Performance Tested Methods Certification The detection of mesophilic microorganisms using the Innovate System luminometer and the RapiScreen Dairy Kits have earned AOAC RI PTM Certification (License #092301) from the AOAC Research Institute. The AOAC validation studies included the following matrices: Matrix Ultra-high temperature (UHT) bovine milk UHT plant-based drink (almond drink) Half and half (10% fat) Protein-based drink (casein) Extended shelf life (ESL) plant-based drink (oat drink) RapiScreen Dairy 5000 Kit, KIT4001 2 INS-KIT4001-REVB Kit Storage and Shelf Life 1. The RapiScreen Dairy Kit for the Innovate System must be stored refrigerated at 2 to 8 °C when not in use. 2. The reconstituted RapiScreen reagents are stable for up to 5 days when stored in the Innovate reagent holder cooling unit. 3. Do not mix reagents from different kit lots. 4. The performance of this kit and its components cannot be guaranteed beyond the expiration date stated on the kit box. Safety and Precautions · Intended for in vitro use only. · Use good laboratory practices when performing this assay and when handling samples and materials. · Dispose of all assay material according to your laboratory standard operating procedures and appropriate prescribed local regulations. The Innovate System method includes procedures that could result in the growth of potential pathogens to detectable levels. Because pathogens can cause human illness, appropriate safety precautions must be taken and personal protective equipment must be worn when handling samples, media, reagents, glassware, equipment and other supplies that could be contaminated with potentially pathogenic bacteria. · Reagents used with the Innovate System assays should pose no hazards when used as directed. Before using this assay, please review the Safety Data Sheet (SDS) available at www.hygiena.com/documents. Hygiena Liability Hygiena will not be liable to the user or others for any loss or damage, whether direct or indirect, incidental or consequential from use of these devices. If this product is proven to be defective, Hygiena's sole obligation will be to replace the product, or at its discretion, refund the purchase price. Promptly notify Hygiena within 5 days of discovery of any suspected defect and return the product to Hygiena; contact Customer Service for a Returned Goods Authorization Number. Contact Information For more information, visit www.hygiena.com/contact. For technical support, visit www.hygiena.com/support. RapiScreen Dairy 5000 Kit, KIT4001 3 INS-KIT4001-REVB