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Invalid Nucleic Acid Test Results May Limit Deceased Donor Organ Utilization
Sara Dionne1, Hillary Akana1, Kaitlin Logue1
1Eurofins Donor & Product Testing, LLC, Centennial, Colorado, USA.
Summary
Invalid discriminatory nucleic acid testing (dNAT) results in organ donors, though rare, cause significant delays and reduce organ availability. Standardized reporting and rapid confirmatory testing are crucial for safe organ allocation.
Area of Science:
- Transplantation immunology
- Infectious disease diagnostics
- Public health
Background:
- Nucleic acid testing (NAT) is critical for identifying viral infections in deceased organ donors.
- Invalid discriminatory NAT (dNAT) results can lead to donor exclusion and decreased organ availability.
Purpose of the Study:
- To analyze the frequency and impact of invalid dNAT results in deceased organ donors.
- To evaluate the clinical and operational consequences of these invalid results on organ utilization.
Main Methods:
- Retrospective analysis of HIV-1/2, HBV, and HCV NAT results from US deceased organ donors.
- Review of donor serologic results and organ utilization outcomes.
- Evaluation of invalid dNAT results across eleven testing laboratories.
Main Results:
- Invalid dNAT results occurred in 0.027% of cases, primarily associated with HCV infection.
- These infrequent results disproportionately impacted organ utilization, with organs not transplanted in 30% of available cases.
- Repeat testing did not resolve invalid results and caused median reporting delays of 22 hours.
Conclusions:
- Rare invalid dNAT results lead to clinical delays, conservative donor classification, and reduced organ utilization.
- Standardized reporting and rapid confirmatory testing are needed to improve clinical decision-making.
- Addressing invalid dNAT results can minimize unnecessary organ discard and optimize organ availability.
