BetaStar® Advanced Training including the Raptor® Integrated Analysis Platform

[Music]

[BetaStar® Advanced Training]

[Using the Raptor® Integrated Analysis System]

Hello!

[Nate: Product Manager — Dairy Residue Diagnostics]

Neogen® is excited to introduce the next generation platform for dairy antibiotic testing BetaStar Advanced with Raptor Integrated Analysis Platform.

This training tutorial consists of three parts:

1. the Raptor platform overview
2. an in-depth step-by-step training using the FDA 2400 form and
3. a best practices section.

Let's begin!

The Raptor integrated analysis platform is a lateral flow test strip reader with built-in incubation.

The Raptor's left side has three USB ports to connect standalone printers and other USB devices. It also has an Ethernet port to transfer data in real-time to a laboratory information management system or other process control systems.

On the center-front, you'll find an industry-first built-in barcode scanner that serves two functions:

1. scanning lot specific information, like expiry dates and
2. scanning sample IDs

The right side includes the Power button a mini USB port for data transfer to a computer and the power input.

On top, a magnetic cover protects the three sample parts when not in use. Each port can test a unique milk sample simultaneously and independently. It's like having three readers in one!

Any milk accidentally spilled into the port so flows out through these three holes without damaging the Raptor.

To power the unit on, plug the power supply into an outlet then into the power input.

Every time the Raptor is powered on it performs a self-check analyzing the camera and LED. If for any reason there is an issue, it will be reported on screen.

You can use the capacitive touchscreen with or without gloves.

The Home screen has three main icons:

1. Run Tests
2. Test Results and
3. Settings

Touching the username takes you to a User Preference screen where you can adjust a number of options including Time and Date, Enable Automatic Printing, Wizards, etc.

Other Home screen icons include:

• Information for calibration status and firmware upgrades
• Data Transfer Mode for USB data transfer only
• Wi-Fi icon to configure Wi-Fi and other connections, and
• the Power icon to put the reader in Power Down Mode

To turn the reader off completely, you must use the Power button.

The Current Date and Time and Reader ID are also displayed on the Home screen.

Touching the Results icon displays all stored results on the reader.

The reader can hold approximately 2000 results and notifies the user when nearing capacity.

A summary displays for each result. Selecting a result brings up a screen that provides the ratios or quantitative results and a photo of the developed test strip.

Press the Print icon to print the Detailed Results screen.

Press the Home icon to return to the Home screen.

Network Connections and User Preferences can be accessed directly from the Home screen as shown previously.

The Lot ID Database is a record of all the test kit lots that have been added to the Raptor.

Calibration Renewal is performed once a year and takes only a few seconds.

To calibrate, insert the included calibration device into the middle port and press Proceed.

The calibration will be updated and the current date will be added to the last renewal section.

For every power cycle the Raptor performs a camera resolution and LED check and notifies the user if there are any issues with the Raptor.

The Advanced Settings are password protected for quality managers to access.

Here you can choose the Language displayed on the Raptor's screen.

Hardware Settings which is further password protected and reserved for Neogen Technical Support only.

Diagnostics is used for annual heater verification. The FDA laboratory proficiency and evaluation team is comfortable with annual heater verification, instead of daily verification, provided the real-time temperature readout displays on screen as well as on a physical printout.

To perform this verification, enable the heaters by pressing the Heaters Disabled button.

Once the temperature has been reached, insert the NIST traceable temperature probe into the first port and set a timer for 5 minutes.

At the end of 5 minutes, compare the reading on the screen to the reading on the temperature probe.

If the reading on the temperature probe is within 1 degree Celsius of the display temperature, the verification is considered valid.

Move to Port 2, then 3 and repeat the process.

If an offset or correction factor is required, select the Offsets tab.

Enter in the appropriate temperature offset for each of the ports.

After all 3 ports have been verified, select Approve.

When prompted to confirm to approve all heaters, choose Yes.

The display changes to reflect the new approved to date.

The Run Test icon looks like a Raptor cartridge.

Select it to enter the Test Routine screen.

The numbers 1, 2, 3 display representing each port. Remember, each port can run independently, simultaneously.

To begin, insert a Raptor cartridge containing at least one BetaStar test strip into any of the ports.

Note that the position of the test strip within the cartridge has no bearing on performance.

The same 400 microliters sample volume is used whether running one, two or three tests for the milk sample.

The Raptor's HD camera automatically scans the test strips barcode and the Lot ID is recognized.

If this is the first time the lot is being used, the Raptor prompts the user to Scan the QR code on the test strip tube.

To do this, hold the test strip tube a few inches away.

The QR code will be scanned transferring lot information such as the assay type and expiry date.

You can either Enter a Sample ID using the on-screen keyboard or Scan a Sample ID with an available barcode.

After the port reaches 65 degrees Celsius, add the sample and select Next.

The Raptor counts down while waiting for fluid front then starts the 5-minute timer when the sample fluid front is detected.

After five minutes, the result appears and automatically prints.

This concludes the overview section of the Raptor Integrated Analysis Platform.

[FDA NCMIS 2400 Form Overview]

Most FDA 2400 forms may seem intimidating at first, but once you understand the overarching concepts within the form, it's easy to follow.

The form is broken into three sections:

1. the equipment and reagents required to run the tests
2. the daily performance checks and
3. the procedure to run the tests

There are 14 bolded sections within the BetaStar Advanced for beta-lactams 2400 Form. Let's go through them.

The first section specifies general requirements for antibiotic testing that are applicable to this 2400 Form. Instead of listing all the details on the form they are referenced here in the first two sections.

The Appendix N General Requirements form can be found on the FDA.gov website.

This next section details all the required equipment and reagents needed to perform the tests.

Beginning with equipment in Section 3, record your Raptor's serial number and the date of last temperature verification.

You can find this information either on the Home screen or within Advanced Settings under Diagnostics.

Incubator temperature will be recorded and printed during each analysis. As stated, this is acceptable for daily temperature check.

Positive and Negative Reader Calibrators are used as part of the daily performance check. A 400 microliter pipetter with disposable tips must be used to dispense the milk sample for confirmation labs or the included poly-pipettes for screening labs.

Section 4 specifies the test kits noting lot number, expiry date, QC date and person responsible.

Section 5 refers to both milk sample and positive negative control mixing.

[Shaking 25 times in seven seconds with a one foot arc is the standard.]

Section 6 refers to reagent stability and preparation. BetaStar Advanced tests are the only tests within the NC IMS Appendix N Program that can be stored at room temperature.

Daily performance checks require previously tested raw milk as a negative control.

This next part refers to the proper labeling of negative controls specifying the numerical ratio and date tested. The negative control must be used within 72 hours or frozen controls can be prepared and used instead.

Once frozen controls are thawed, they must be used within 48 hours.

Neogen supplies positive controls that contain two different beta-lactam antibiotic.

Positive controls are prepared by reconstituting the drug with one milliliter of negative control milk.

If using a previously frozen positive control, the control should be properly labeled and have the ratios on the label.

If the positive control is being prepared fresh, you'll need to come back and complete the ratios after the daily performance check is complete.

Just like the negative controls, positive controls can also be frozen. Do not freeze the positive controls if previously frozen negative milk was used to reconstitute the positive control.

Section 7 details the daily performance checks as well as verifying that annual verification is within compliance.

Annual calibration of the instrument is required and is a requirement in many other food safety programs such as SQF and BRC.

To verify the date of last calibration, select the Information icon from the Home screen. For an overview on how to perform this annual verification, please refer to the first part of this video tutorial.

The daily reader check is designed to assess the readers ability to distinguish between a positive and negative result. The daily check also tests every possible interpretation/permutation. Each of the three ports is evaluated as well as each of the three positions within the cartridge.

Each cartridge has 12 total test lines which are analyzed to provide a combined ratio. A ratio is the measurement of the test line intensity divided by the control line intensity. This provides a numerical relationship and determines a positive or negative result. The positive calibrators must produce a ratio less than or equal to 0.85 for each port.

The daily calibration process can now be automated to provide the user with step-by-step instructions in accordance with the 2400 Form.

To enable the daily calibration wizard, please select User Preferences and navigate to the Wizards tab.

Select both the Daily Calibration Wizard and Presumptive Positive Wizard, then return to the Home screen by selecting the Home icon.

You'll notice that a fourth main icon is now present depicting a Magic Wand.

Select the Wizard icon to begin the Daily Calibration Test Routine.

There are on-screen prompts indicating the next step in the daily calibration process.

There are also icons above: yellow, which indicate which step you are on, and green, which represent the steps completed in the process.

Begin by inserting the Negative Reader Calibrator in the first port.

The reader automatically recognizes and analyzes the calibrator then prompts the user to move to the next step.

Continue following the on-screen prompts until the Reader Calibrator section is complete.

With the reader's ability to distinguish between a positive and negative result established, you can now continue to follow the on-screen prompts to run the negative and positive control to ensure the particular lot you're using performs as expected with a known positive and negative sample.

Only one negative and one positive test needs to be performed as this is an assessment of kit lot performance.

When you receive a brand new kit lot, this assessment must also be performed using positive and negative controls.

After the controls are complete, a daily control summary will appear on the screen and will also be printed.

Section 8 refers to the test procedure.

Make sure to set out the number of test strips and cartridges to be used for the day. Unused test strips must be discarded at the end of the testing day.

A beta-lactam test strip is added to the Raptor cartridge and up to two more test strips for other antibiotics or residues may also be added.

Place the cartridge into any of the three ports.

The Lot ID Barcodes on the test strips are automatically scanned. If the QR code for the lot of strips has not been entered into the system, the Barcode Reader automatically turns on.

Scan the QR code found on the container. Either Enter a Sample ID with the on-screen keyboard or Scan a Sample ID with the built-in barcode scanner.

Add the 400 microliters of milk to the back of the cartridge.

After loading the sample, leave the tip in the back of the cartridge as a visual cue you've already added the sample.

Press Next to continue.

The countdown begins while waiting for fluid front as the camera is constantly looking for the sample fluid front.

When the sample fluid front reaches the test strip membrane, the 5-minute timer starts. This ensures the 5 minute incubation is the same for everyone running the test.

Since all three ports operate independently, you can move on to the next sample when the first sample is in process.

After the 5 minute incubation period, the result displays on the screen and prints automatically.

Remove the cartridge from the instrument and discard.

Touch any given result to see details. If the ratios are greater than or equal to 1.0, the test is negative. If the ratio is less than 1.0, it is positive.

For Presumptive Positive and Confirmation testing you must run two different cartridges containing a beta-lactam test strip with your positive and negative controls. Two beta-lactam test strips cannot be added to the same Raptor cartridge to run the sample in duplicate.

With the Presumptive Positive Wizard previously enabled, the user can engage the Presumptive Positive Wizard to receive step-by-step, on-screen instructions to perform the testing requirements.

If one or more of the duplicate samples is found to be positive, a prompt to engage the Confirmation Wizard will appear to perform the testing requirements.

As not all laboratories are confirmation testing sites, the Confirmation Wizard can be engaged when the presumptive positive sample arrives at a confirmation testing location.

To do this, start by navigating to User Preferences and the Wizards tab, then by selecting the Confirmation Wizard button.

If for any reason it is not conducive to use the Wizards, they can be disabled and Presumptive Positive and Confirmation testing can resume by following the steps outlined in the 2400 Form.

For traceback testing and reinstatement, refer to the Appendix N General Requirements and the latest revision of Ma-85 on the FDA.gov website.

This concludes the 2400 Form overview section. If you have any questions, please contact us at any time.

Now I'd like to take a minute to go over some best practices for using the Raptor Integrated Analysis Platform.

When using Neogen's BetaStar test strips with the Raptor reader there's one easy way you can avoid user error: pipetting carefully.

When pipetting your milk sample into the Raptor cartridge, don't squeeze too quickly or the force might cause milk to spell out of the cartridge and into the reader or form bubbles.

To avoid spillage, squeeze smoothly and evenly so the milk stays where it belongs, better ensuring accurate results and preventing damage to the Raptor reader.

To clean the Raptor after a spill, use a common, extended, cotton-tipped swab.

This is the proper way to insert the cartridge into the Raptor port. Dropping it in may cause the test strips to pop out of position.

It's important to pay attention to the on-screen prompts. For instance, do not add your milk sample unless the sample port is at the correct temperature. Adding the sample too early will extend the total incubation time of the assay, meaning you'll need to repeat the test.

There's no need to worry if you touch the test strip when loading it into the Raptor cartridge because there's a protective over-laminate across the device.

When adding the milk sample, many people leave the poly-pipette in the back of the cartridge as a visual aid that the cartridge has been dosed. If you do this, don't lift the cartridge with the poly-pipette because it may trigger the sample fluid front detection and start the incubation timer.

Neogen is dedicated to the success of the NCIMS Program and will continue to provide best practices to support it.

We look forward to working with you and your team in the future.

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