Fecal Occult Blood Testing Using the Sentinel FIT Alliance Application - Routine Operation and Workflow

Continue Continue Continue Continue Main Scene Fecal Occult Blood Testing Using the Sentinel FIT Alliance Application - Routine Operation and Workflow Day in the Life of the Lab Series Look for more content in our Day in the Life of the Lab Series. Welcome Welcome to the Fecal Occult Blood Testing Using the Sentinel FIT Alliance Application - Routine Operation and Workflow Training. A part of our Day in the Life of the Lab Series. Atellica CH Analyzer configurations that support the FIT assay: Direct Load Sample Handler Sample Handler with Decapper Blank Hi, it’s me Sandy. I am an experienced user and I have responsibility for training others in my lab on the Atellica analyzers. One of the new hires recently asked me about the Fecal Immunochemical Test Assay commonly referred to as FIT and what workflow we should follow to utilize this assay in our lab. I am going to show you how I train people in my lab on the proper procedure so we can continue to process samples efficiently. I like to make sure everyone uses the same steps. The FIT assay is supported on the Atellica CH Analyzer and the Atellica CI Analyzer. For the Atellica CH Analyzer, the supported configurations are the Direct Load, Sample Handler, and Sample Handler with Decapper. Atellica CI Analyzer configurations that support the FIT assay: Rack Handler Sample Handler Sample Handler with Decapper Blank For the Atellica CI Analyzer, the supported configurations are the Rack Handler, Sample Handler, and Sample Handler with Decapper. Let’s Begin – Terminology Table with 2 columns and 4 rows FOB Fecal Occult Blood Sentinel FIT Alliance Application FIT = Fecal Immunochemical Test (Siemens Healthineers Assay name) Sentinel FOB Gold® Product line name from Sentinel Diagnostics Sentinel FOB Gold® NG Wide Reagent name from Sentinel Diagnostics This is an Alliance Application assay that was developed with Sentinel Diagnostics. Blank I would like to begin by saying welcome to the world of GI testing and before we get started, I would like to go over some of the terminology we will be using as we explain this workflow in my lab. FOB means Fecal Occult Blood, which is the analyte we’re measuring. To understand the next term, you must understand that this test is an Alliance Application assay that was developed with Sentinel Diagnostics. Siemens Healthineers named this test the Sentinel FIT Alliance Application, which we call FIT for short, which stands for Fecal Immunochemical Test. FIT is the Siemens Healthineers assay name and this is the name that appears on the application sheet on the Siemens Healthineers website. Sentinel FOB Gold is the product line name that is used on the Sentinel IFU on the Sentinel Diagnostics website and also the name on the reagent box and on the patient collection tube. Finally, Sentinel FOB Gold NG Wide is the reagent name from Sentinel Diagnostics. What is FIT? FIT = Fecal Immunochemical Test FOB Gold Patient sample collect tube Quantitative measurement of human hemoglobin Can be used for: Screening for early stages of colorectal cancer Symptomatic testing for other lower gastrointestinal tract conditions associated with bleeding such as colorectal carcinoma, colon polyps, Crohn’s disease, and ulcerative colitis Blank The test utilizes the FOB Gold sample collection tube. This test provides a quantitative measurement of human hemoglobin in the fecal sample, also referred to as fecal occult blood. Journey of FIT Sample Did you know? That the FIT Assay tube has two orientations? Makes it easy for the patient as well as my lab. Let me show you the journey of the sample… Blank Did you know that the FIT assay tube has two orientations? You may wonder, what does that mean? Well, it makes it easy for the patient as well as my lab! Each end of the tube is used in different phases of testing. One end is for collection of the sample and the other end is for access to the buffered sample for analysis by the instrument. The sample can be collected either by the patient at home or in a stool sample collection container in the hospital and the lab then will take a sample from the collection and insert in the tube. Let’s look at an example of a recent journey of a sample that was collected by the patient and delivered to our lab. My manager is going to help with narrating this journey for you. A crucial test for Colorectal Screening The Journey of FIT FIT Journey Welcome to the journey of FIT, a crucial test for colorectal screening. Our story begins in a doctor's office. Meet Grace, a patient visiting Dr. Hunter for her annual physical. Dr. Hunter recommends the FIT Test for colorectal screening. Grace is happy to hear from Dr. Hunter that the FIT test has been designed so no preparation by the patient is required. At the Patients Home… FIT Journey At her home. Grace reads the collection instructions meticulously. She opens the green cap, removes the stick and uses the scooper. At the Patients Home… The distribution of hemoglobin in feces is not homogeneous Important to physically collect the sample in four different areas of the sample stool and perform a crosswise movement FIT Journey Did you know that the distribution of hemoglobin in feces is not homogeneous? As stated in the instructions it is important to physically collect the sample in 4 different areas of the sample stool using the sampling stick. Then perform a crosswise movement as Grace has done. At the Patients Home… The Tube: Includes a buffer that dilutes the sample as well as extracts and stabilizes the hemoglobin if present, from sample to transportation. Did you know? The tube has a device to ensure that a definitive measurable amount of sample is collected. “The FIT collection tube made it so easy!” - Grace FIT Journey Grace then avoids squeezing the tube and closes it tightly. The patient collection tube not only is a collection device but one that includes a buffer that dilutes the sample as well as extracts and stabilizes the hemoglobin, if present, from sample to transportation. Did you know that the tube has a device to ensure that a definitive measurable amount of sample is collected? Grace then places her sample into the prepared package for delivery to the lab. She comments to herself how the FIT collection tube made it so easy. FIT Sample Arrives at the Lab… Check the Sample If the sampling was performed correctly: The buffer should have a brownish color Grooves of the sampling stick should be clean FIT Journey Next, the FIT sample arrives at the lab in the accessioning area. Lab technicians check that the sample was stored properly, labeled, and at room temperature before testing. The tube has a transparent body to allow you to visually check the status of the sample inside the buffer. If the sampling was performed correctly, the buffer should have a brownish color and the grooves of the sampling stick should be clean, indicating that the sample is completely dissolved. It happens sometimes that if the stool sample is too hard, the sampling is not successful. In the worst-case scenario, no sample is collected at all, in this case the buffer would appear transparent and in this case, a new sample collection is needed. FIT Sample Arrives at the Lab… Did you know? The sample is stable for 14 days at room temperature and can be kept for 32 days at 2-8°C FIT Journey Did you know this about the sample? It is stable for 14 days at room temperature and can be kept for 32 days at 2-8 degrees celsius. FIT Sample Arrives at the Lab… “When the tube arrives – re-barcode it!” - Sandy FIT Journey A quick tip from Sandy. When the tube arrives in your lab, make sure you rebarcode it. The Atellica Solution cannot read the barcode that comes on the tube. Loading the FIT Sample… Load the tubes directly with the colorless cap end up If your system does not include a Decapper, remove colorless cap when loading It is not necessary to use a special rack “The FIT test cannot be run on the same analyzer running whole blood or hemolysate samples.” - Sandy FIT Journey Next in the journey, loading the FIT sample. Load the tubes directly with the colorless cap end up. If your system does not include a Decapper, remove the colorless cap when loading. It is not necessary to use a Special Rack for the FIT tubes. The FIT tubes can be mixed with other samples in a Routine rack. Be aware that the FIT test cannot be run on the same analyzer running whole blood sample or hemolysate samples. Due to the sensitivity of the FIT test, whole blood and hemolysate samples can not be performed on the same Atellica CH or CI analyzer. If you have an Atellica Solution with 2 CH analyzers or 2 CI analyzers, one can be used for whole blood and hemolysate samples while the other is running the FIT test. For Rack Handler and Direct Load configurations, your lab will need to designate a colored sample rack to load the FIT patient sample tubes. If your system has… A Sample Handler: You can configure a Sort Group for the FIT samples to be sorted once processing is complete. One option is to sort samples to a designated location based on a positive result, for easy follow up.   FIT Journey If your system has a Sample Handler. You can configure a Sort Group for the FIT samples to be sorted once processing is complete. One option is to sort samples to a designated location based on a positive result, for easy follow up.   If your system has… A Sample Handler Connect: All tubes must be front loaded on the Sample Handler. The FIT tubes cannot be processed through the Sample Handler Connect / automation line. FIT Journey If your system has a Sample Handler Connect. All tubes must be front loaded on the Sample Handler. The FIT tubes cannot be processed through the Sample Handler Connect or automation line. If your system has… A Decapper: The Decapper will remove the cap and discard it, then route the tube for aspiration and testing. FIT Journey If your system has a Decapper. The Decapper will remove the cap of the FIT sample and discard it, then route the tube for aspiration and testing. FIT Journey That concludes our journey of the FIT sample from initial patient visit at their doctor's office, to collection at the patient’s home, lab arrival and sample processing. Are you ready to learn about FIT sample results? Sandy, take it away! Sample Results FIT Test can be used to provide: Qualitative result for asymptomatic colorectal cancer screening The laboratory determines its own cut-off based on patient population Quantitative result for patients with symptomatic lower GI hidden bleeding conditions Blank Thank you. Now that you know the journey of the sample, did you know that the FIT test can provide both qualitative and quantitative results? The results can be used to screen for asymptomatic colorectal cancer, to help to triage patients for a follow up colonoscopy or other tests. And FIT can also be used for identifying or screening for other possible lower GI bleeding conditions. A normal stool sample should not contain hemoglobin. Test results can be reported in two units of measure, ng/mL or ug of hemoglobin / g of feces. The instrument can be configured for the unit of measure your laboratory requires. As always, be sure to follow your lab protocol for test result interpretation and reporting. Knowledge Check You have just learned about the Fecal Occult Blod Testing Using the Atellica® CH Sentinel FIT Alliance Application – Routine Operation and Workflow. Select Start to test your knowledge of the presented content. Start Knowledge Check Select two (2) answers. Knowledge Check Which of the following are TRUE about the sample tube used for the FIT test? The tube body is transparent in color. The tube has a device to ensure that a definitive measurable amount of sample is collected. The white cap is removed for sample collection. The lab does not need to re-barcode the sample tube once it arrives to the lab. Multiple Answer One or more answers are incorrect. Knowledge Check Completion Review Retry Retry Continue Continue You have just completed the Knowledge Check. Select Review to assess how your responses compare to the correct answers. Select Retry to test your knowledge again or select Continue to advance through the course. Knowledge Check Completion Fecal Occult Blood Testing Using the Sentinel FIT Alliance Application - Analyzer Preparation Online Training Blank Thank you for taking the time to learn more about the Fecal Occult Blood Testing Using the Sentinel FIT Alliance Application – Routine Operation and Workflow. For more information on running tests on the Atellica Solution, you can search by specific keywords on Online Help, or check out the Siemens Healthineers Academy, where you have access to additional job aids and videos. For more advanced information on how to set up the FIT assay in your lab, refer to the Fecal Occult Blood Testing Using the Sentinel FIT Alliance Application – Analyzer Preparation Online Training. I look forward to spending another day in the life of the lab with you very soon and sharing more information about the Atellica Solution. Disclaimer Please note that the learning material is for training purposes only. For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. 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