The Transplant Journey and the Role of Clinical Diagnostics
Demystifying Your Journey to Wellness
While each person’s journey is unique, here is an overview of what you can expect to experience before, during, and after your transplant. One of the most important initial steps you can take is to empower yourself with information, so we have prepared this summary to help demystify your journey—specifically, to help you understand the role modern diagnostics play in supporting your care throughout the transplant process and your path toward an improved quality of life.
Understanding the Six Major Phases of the Transplant Process
The tests that labs use to help understand the genetic and physiological realities between a donor and recipient are vital to the transplant process, and will hopefully seem less mysterious to you. Ultimately, what all transplant diagnostics have in common is that, at every phase of your journey, they help your transplant team better understand your immune system. They also help make sure that you are ready to receive the new organ as quickly as possible, and that, after surgery, it will function harmoniously with your body. Even with the challenges of surgery and medication, transplantation is far less restrictive than other treatment options and holds the promise of a dramatic increase in both the quality and length of your life. (Click to expand this card)
The journey begins when your doctor identifies the need for a transplant. Depending on the nature of your case—the type of transplant needed and the urgency of your medical condition—your doctor may advise you to make lifestyle changes to increase the likelihood of a successful transplant or of your eligibility for placement on the organ transplant waiting list.
Your doctor will then refer you to a transplant program for further evaluation, or you may choose a program based on your location, resources, insurance, or other circumstances.
To begin preparing for your potential transplant, your transplant program team will learn more about you and help you understand the decisions that will determine your individual transplant journey. There are two types of donor organs for which you may be eligible: organs from either a deceased or living donor. Heart, and most lung and liver, donations are from deceased donors. For kidney, stem cell, and other transplant types, you may seek a living donor. Both types have a high success rate, but the scheduling can be more predictable with living donors. According to the Organ Procurement and Transplantation Network, in 2020, 85% of organ donations were from deceased donors. And while most living donations are from family members, one out of four are from donors who are not biologically related to the recipient (American Transplant Foundation). You will confer with your transplant team to determine the right type of donor for you.
Each transplant hospital team has its own criteria for determining your eligibility for receiving a transplant or being placed on the national waiting list. If you are found to be a good transplant candidate through the screening process, your team may schedule your transplant if you have been matched with a living donor, or they may add you to the waiting list, where your wait time will vary depending on your needs and the availability of a compatible donor. Transplant hospitals in the United States enter information from donors and candidates into a database operated by the United Network for Organ Sharing (UNOS), which helps match candidates with donor organs.
As part of determining your transplant eligibility and needs, the pretransplant screening process involves three main types of clinical diagnostics (laboratory tests):
- Blood-type testing determines your “ABO” blood type. Everyone has one of the four inherited blood types: A, B, AB, or O, and within those types are many subtypes; this test is important since ideally the transplant donor and recipient should have compatible blood types. Labs use real-time PCR technologies to identify ABO blood type quickly and accurately.
- HLA typing (tissue typing), along with blood type testing, helps your transplant team assess the compatibility of a donor. This test looks at gene types that encode human leukocyte antigens (HLAs), the molecular markers on your cells that help your body identify the difference between self (i.e., parts of your body) and non-self (i.e., things that are not part of your body). Recognizing this difference helps the body protect itself by attacking what isn’t a part of it, like a bacterial or viral infection. When your body recognizes antigens on a transplanted organ as different from its own, it directs white blood cells to attack. This is what is meant by rejection of a transplanted organ. In other words, HLA typing gives your transplant team information about how your body recognizes what is you and what is new.
Modern HLA typing uses next-generation sequencing (NGS) technology to indicate whether the donor’s and recipient’s HLA genes are closely matched. In some transplants, such as for the kidney, a close match results in better graft function, longer graft and patient survival, and reduced risk of rejection. A graft is any tissue that is transplanted from one body to another.
To further help prevent rejection, when you receive a new organ, you will be prescribed immunosuppressants—medicines that help control your immune system’s response to the organ. In kidney transplant patients, the level of donor and recipient HLA compatibility also helps determine how much immunosuppressant is needed to enable acceptance of the new organ. - HLA antibody testing determines whether your body already has antibodies formed against HLA. While most patients won’t have HLA antibodies, if you do, it will be important to find a compatible donor that doesn’t display that antigenic target, so your immune system won’t recognize the transplant, and your body won’t trigger a rejection event.
Under what conditions would you already have antibodies against a donor? The formation of HLA antibodies usually occurs via one of three different routes: previous transplantation, previous transfusion of blood products, or pregnancy.
If you have received a previous transplant where there was not an optimal match, you may have formed antibodies against that transplant. Some patients who have had multiple transplants may have formed many different HLA antibodies. These patients may find that identifying a match for a further transplant is significantly more challenging.
In the case of blood transfusions, cells with HLA genes that don’t match those of the person receiving the blood can be passed on to the recipient from the blood donor. This can result in an immune response in the patient, which may in turn lead to antibody production.
Because a pregnant woman is exposed to the genetic material of the fetus, and the fetus contains HLA-coded genes from not only the mother but also the father, there is a high probability that HLA antibody formation will follow. Thus, clinicians have observed that there is a significant number of women on transplant waiting lists worldwide who have antibodies to HLA formed in this way.
Even if your pretransplant test does not identify the presence of HLA antibodies, your antibody profile can change. That’s why you will undergo regular blood tests for HLA antibody screening when you are placed on a waiting list.
The most important thing to know about HLA antibodies and your transplant journey is that transplant teams have tools and strategies to identify and characterize these antibodies and to know exactly what they target. Your transplant team can leverage that knowledge to help find the right donor. In recent years, patients with HLA antibodies have begun to receive priority status from organ allocation systems worldwide since their cases present a greater challenge. Additionally, laboratories now have at their disposal an advanced suite of antibody detection products like our LABScreen™ Single Antigen assays. Together, advancements in policy and innovation have led to significant increases in the successful transplant rates of even the most immunologically challenging patients. Thus, while HLA antibodies can complicate the transplant journey, the majority of patients will still be matched with a suitable donor.
Immediately prior to surgery, an additional test, called a crossmatch test, is performed to verify that your donor organ is compatible. Think of it as a miniature test run on the transplanted organ, undertaken in the laboratory. Donor and recipient blood samples are mixed. If antibodies in the recipient's blood attack and kill the donor cells, the crossmatch is considered positive. This means the recipient has previously developed antibodies against the donor’s cells and the transplant cannot move forward. If the crossmatch is negative, the recipient does not have antibodies against the donor HLA and the transplant can be performed.
For heart and lung transplant patients, the crossmatch test is typically performed immediately after surgery, though there are exceptions where the transplant clinical team may choose to perform it beforehand.
Some transplant centers may perform a “virtual” crossmatch test, in which data on the patient’s HLA typing and antibody status are compared with the donor’s typing via analytical software, such as our HLA Fusion™ Software. This allows the transplant center to assess how a patient’s antibodies would interact with the donor cells in a regular crossmatch test. This virtual test is particularly helpful in cases when the transplant clinical team is trying to determine whether a donor organ from outside the regional area would be a good match for their patient.
The typical recovery time after transplant surgery can vary depending on the type of transplant. Kidney patients may require 3 to 4 weeks for recovery; heart and lung patients may take around 6 to 8 weeks. Regardless of the type of transplant, this is when you will begin your regimen of immunosuppression medication, which you’ll need to maintain for the life of your transplant. Transplant doctors emphasize the critical importance of complying with this medication regimen since there is a high rate of correlation between lack of adherence and transplant rejection. Simply put: after your transplant, taking your medicine becomes as vital a part of your life as breathing, eating, and sleeping.
Your journey doesn’t end with the transplant—even if you’ve received a donor organ from an excellent match, it’s not an exact duplicate of your organ. Therefore, an organ transplant is a lifelong treatment rather than a cure. Your life after transplant will include continued adherence to your medical regimen as well as regular monitoring for donor-specific antibodies (DSAs), usually every few months in the first year and less frequently in subsequent years, depending on your health, the circumstances of your transplant, and the protocols of your transplant center. You may require additional tests such as biopsies during the monitoring phase, and your immunosuppressive regimen may be adjusted based on the results.
In cases where your medical team may need a closer view of the state of your transplanted organ, a biopsy of the transplant organ may be required. By taking a biopsy sample, your transplant clinician can determine whether your organ is normal or may be experiencing rejection or injury. A test such as our Molecular Microscope® Diagnostic System for Heart and Kidney (MMDx® Heart and MMDx® Kidney) allows your clinical team to assess the health of the organ on a molecular level and make a more accurate diagnosis.
Testing Enables Life!
The tests that labs use to help understand the genetic and physiological realities between a donor and recipient are vital to the transplant process, and hopefully, they now seem less mysterious to you. Ultimately, what all transplant diagnostics have in common is that, at every phase of your journey, they help your transplant team better understand your immune system. They also help make sure that you are ready to receive the new organ as quickly as possible, and that, after surgery, it will function harmoniously with your body. Even with the challenges of surgery and medication, transplantation is far less restrictive than other treatment options and holds the promise of a dramatic increase in both the quality and length of your life.
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The Transplant Journey and the Role of Clinical Diagnostics
While each person’s journey is unique, here is an overview of what you can expect to experience before, during, and after your transplant.
