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Standardized screening, diagnosis and monitoring are critical for transplant patients and donors

Transplant patients and their donors must be screened, diagnosed and monitored for common transplant-associated infections with polymerase chain reaction (PCR) and serology tests. Transplant recipients are often immunosuppressed and can become seriously ill even with minor infections. 

 

 

About 50% to 65% of transplant recipients will develop symptomatic viral infection within 90 days post–solid organ transplant without prophylaxis, and infections account for about 20% of the deaths within 100 days after hematopoietic stem cell transplant (HCT). The earlier these infections can be detected, the higher the likelihood that clinicians can place patients on treatment to produce better outcomes.3,4

Labs have a critical role to play in screening viruses in the donor and the recipient, as well as monitoring the transplant recipient over time. Labs are charged with making sure that patients receive comparable diagnostic testing across institutions and throughout the continuum of care. This can be complex due to many patients receiving their testing and monitoring labs at different locations from where their transplant is performed.

Post-transplant viral infections: Challenges with clinical management

Hear from Elena Beam, M.D., Mayo Clinic College of Medicine and Science, and Joseph Yao, M.D., Mayo Clinic, as they discuss the need for standardization in post-transplant diagnostics with an emphasis on cytomegalovirus (CMV), Epstein-Barr Virus (EBV) and BK polyomavirus (BKV).

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Need for transplant standardization

A transplant patient’s journey can span several healthcare facilities, including transplant centers that may be hundreds of miles away from the coordinated care of the patient’s local specialist. Transplant recipients must be monitored closely for viral infections such as CMV, EBV and BKV after transplantation. Treatment for these viral infections is driven by the viral load test result in each case. The more accurate and comparable the test result is across institutions or testing sites, the more informed the clinicians will be. For example, CMV PCR results are needed to assess virologic response to treatment, and to determine duration of treatment.5 The use of different testing methodologies across various sites makes it difficult to compare viral load results, not to mention that send-out test results may take up to six to 10 days to return.

For many years, testing for transplant viruses could only be accomplished via laboratory-developed tests (LDTs). LDTs are protocols developed, validated and used by a single laboratory to perform a specific test that has not been approved by a regulatory body.6 Studies have demonstrated 2-4 log (copies/mL) inter-assay variability with LDTs using the same samples.7 We now have access to in-vitro diagnostic (IVD) tests, developed and manufactured by an IVD manufacturer, which undergo rigorous clinical validation and a regulatory body approves. This means that transplant patients can have access to reliable test results regardless of the facility utilized. This also means that clinicians can be more confident in the treatment decisions they are making for these patients. 

Without access to accurate viral infection monitoring tests, clinicians face numerous challenges when deciding on their patients’ optimal treatment plans. This could potentially result in the patient facing adverse outcomes related to infection or their new organ.

Roche transplant portfolio

Roche’s portfolio spans the core 10 to 12 tests needed for pre-transplant and post-transplant monitoring, as well as several supporting assays. Roche is committed to developing more transplant related testing to overcome the existing gap between the range of tests needed and what is actually FDA approved or cleared today. 

CMV, EBV, BKV viral assays that are run on instruments in the cobas x800 series are all IVD tests, which enable commutability within and across institutions. With the launch of the cobas 5800 series, labs have access to instruments with a 24-well format, especially convenient for CMV, EBV and BKV. 

Roche offers dozens of tests to monitor infections commonly associated with transplant patients, including core tests, such as cobas® CMV, cobas® EBV and cobas® BKV, as well as tests commonly performed on transplant patients, such as cobas® HIV-1/HIV-2 Qualitative, cobas® HIV-1 Quantitative and cobas® HCV  tests. Roche continues to develop new molecular and serological tests that can be used to monitor transplant patients throughout the continuum of care.

cobas 5800
cobas 5800 System

The cobas 5800 System is a compact, fully automated molecular system that balances a broad menu and testing efficiency with flexible workflows and ease-of-use.

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cobas 6800
cobas 6800 System

The cobas 6800 System can help you meet the growing needs of your lab with highly efficient workflows, from sample processing to result interpretation.

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cobas 8800
cobas 8800 System

The cobas 8800 System can help you meet the growing needs of your lab with highly efficient workflows, from sample processing to result interpretation.

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References

  1. https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/# Last accessed May 9, 2024. 

  2. https://bloodstemcell.hrsa.gov/data/donation-and-transplantation-statistics Last accessed May 9, 2024. 

  3. Fishman JA. Infection in Organ Transplantation. Am J Transplant. 2017 Apr;17(4):856-879. doi: 10.1111/ajt.14208. Epub 2017 Mar 10. PMID: 28117944.

  4. Freeman RB Jr. The 'indirect' effects of cytomegalovirus infection. Am J Transplant. 2009 Nov;9(11):2453-8. doi: 10.1111/j.1600-6143.2009.02824.x. PMID: 19843027.

  5. Razonable RR, Humar A. Cytomegalovirus in solid organ transplant recipients-Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019 Sep;33(9):e13512. doi: 10.1111/ctr.13512. Epub 2019 Mar 28. PMID: 30817026.

  6. https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests. Last accessed April 18, 2024.

  7. Hayden RT, Sun Y, Tang L, Procop GW, Hillyard DR, Pinsky BA, Young SA, Caliendo AM. Progress in Quantitative Viral Load Testing: Variability and Impact of the WHO Quantitative International Standards. J Clin Microbiol. 2017 Feb;55(2):423-430. doi: 10.1128/JCM.02044-16. Epub 2016 Nov 16. PMID: 27852673; PMCID: PMC5277511.

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