hygiena KIT4015 RapiScreen Dairy Kit for Autosampler Instructions

: June 12, 2024
: Hygiena

Table of Contents

hygiena KIT4015 RapiScreen Dairy Kit for Autosampler
Test Procedure
Additional Information
Safety and Precautions
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

hygiena KIT4015 RapiScreen Dairy Kit for Autosampler

hygiena-KIT4015-RapiScreen-Dairy-Kit-for-Autosampler-
PRODUCT

RapiScreenTM Dairy Kit for Autosampler Product No. KIT4015 (25,000 assays)

Introduction Description and Intended Use:
The RapiScreenTM Dairy kit, together with the InnovateTM Rapid Microbial Screening System (luminometer and software), provides a rapid method to confirm the absence of microbial contamination in long-life dairy and dairy- alternative products. After first enriching samples by incubation in their original packaging, the Innovate System uses ATP bioluminescence to rapidly determine the presence/absence of microorganisms in the sample.

Kit Components of the RapiScreen Dairy Kit (25,000)

Quantity: 50 x 500 assay vials
Quantity: 5 x 575 mL bottles
Quantity: 4 x 325 mL bottles
Quantity: 50 x 500 assay vials
Quantity: 3 x 230 mL bottles
Quantity: 2 x 290 mL bottles
Quantity: 20 each
Quantity: 10 each
Quantity: 10 each
Quantity: 280 each

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Test Procedure

Getting Started

Prepare the sample by incubating it in its original packaging.
Set up the Innovate System.
Carefully open a vial of Sensilux (yellow cap) and dispense the first 25.5 mL Dilutor DS into the vial, swirl.

Protocol

1. Shake the sample to ensure any contamination is well-mixed.

Pipette 50 L of the sample into a well.*
the microtiter plate in the luminometer which will automatically run the following RapiScreen Dairy protocol:
Inject 25 L of ATX
Incubate for 10 minutes, shaking*
Inject 50 L of Cellsolver DE
Extract for 5 seconds
Inject 100 L of Sensilux
Measure and record the light emitted in Relative Light Units (RLUs)

Refer to the Innovate System Operator Manual for full instructions on the programming and operation of your instrument.
Protocol steps marked with an asterisk (*) refer to parameters that may need to be set for individual users or applications. Contact your local Technical Support Representative for further information.

Additional Information Interpretation of Results:
Compare the RLU values of the samples and determine the pass/fail status of each sample. Refer to the Innovate System Implementation Guide or your local Technical Support Representative to determine how the RLU readings should be interpreted.

Safety and Precautions:
The reagents in this kit do not pose any risk to health when used in accordance with standard laboratory practices. The reagents are non-toxic and may be flushed down the drain after use. For further safety instructions, refer to the Safety Data Sheet (SDS).

Covered by U.S. Pat. Numbers 5.583.024/5.674.713/5.700.673

Document number: INS-KIT4015-001 REVA

Kit Components of the RapiScreen Dairy Kit (25,000)

Required Materials (Not Provided)

Innovate System (Product No. MCH4000)
Autosampler III System (Product No. MCH4003)
ATP Positive Control Kit (Product No. KIT4014)
Pipette and tips

Important Tips and Notes Before Starting the Test

Do not mix reagents from different kit lots.
Wear gloves when running the test to prevent contamination.
Observe standard aseptic procedures when handling or transferring samples and reagents.

Test Procedure

Getting Started

Remove one vial of each reagent from storage at 2 to 8 °C.
Unscrew the Microwash cap and transfer 50 mL of Microwash to both 50 mL blue-capped PP vials on-board the Innovate System.
Carefully open a vial of Sensilux (yellow cap) and dispense the first 25.5 mL Dilutor DS into the vial, swirl gently to mix and pour it into the 150 mL PP vial. Do not shake. Dispense the second 25.5 mL Dilutor DS directly into the 150 mL PP vial.
Carefully open a vial of ATX (red cap) and dispense 13.2 mL of Dilutor DA into the vial, swirl gently to mix and pour the total contents into the 50 mL red-capped PP vial.
Place the reagents, including the Cellsolver DE bottle, in the Innovate System reagent holder and leave for 15 minutes before use.
Prime the Innovate System luminometer with the prepared reagents.

Protocol

Incubate the sample in its original packaging at 30 °C (or other validated temperature) for a minimum of 48 hours.*
Shake the sample to ensure any contamination is well-mixed.
Pipette 50 μL of the sample into a well.*
Place the microtiter plate in the luminometer which will automatically run the following RapiScreen Dairy protocol:
- Inject 25 μL of ATX
- Incubate for 10 minutes, shaking*
- Inject 50 μL of Cellsolver DE
- Extract for 5 seconds
- Inject 100 μL of Sensilux
- Measure and record the light emitted in Relative Light Units (RLUs)

Refer to the Innovate System Operator Manual for full instructions on the programming and operation of your instrument.

Protocol steps marked with an asterisk (*) refer to parameters that may need to be set for individual users or applications. Contact your local Technical Support Representative for further information.

Additional Information

Interpretation of Results
Compare the RLU values of the samples and determine the pass/fail status of each sample. Refer to the Innovate System Implementation Guide or your local Technical Support Representative to determine how the RLU readings should be interpreted.

Controls
Hygiena® recommends running an instrument blank, reagent control and ATP positive control on each day before using the instrument to ensure the system is functioning properly.

Storage and Shelf Life

Store at 2 to 8 °C (36 to 46 °F) upon receipt.
Once reconstituted, the reagents will remain stable for 5 days when stored in the Innovate System reagent cooling unit.
The performance of this kit and its components cannot be guaranteed beyond the expiry date stated on the kit box.

Safety and Precautions

The reagents in this kit do not pose any risk to health when used in accordance with standard laboratory practices. The reagents are non-toxic and may be flushed down the drain after use. For further safety instructions, refer to the Safety Data Sheet (SDS).

Hygiena Liability
Hygiena will not be liable to 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. Please 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 or email us at: