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Nucleic acid testing for monkeypox in United States blood donor specimens
Jamel A Groves1, Laura Tonnetti1, Deanna Self2
1Scientific Affairs, American Red Cross, Rockville, Maryland, USA.
Transfusion
|August 3, 2023
Summary
A new monkeypox virus (MPXV) assay shows high specificity for detecting MPXV DNA in blood donations. This research use only assay could aid in safeguarding the blood supply during outbreaks.
Area of Science:
- Virology
- Public Health
- Blood Transfusion Safety
Background:
- The 2022 multi-country monkeypox (mpox) outbreak prompted monitoring of blood supply safety.
- While mpox virus (MPXV) is not known to be transfusion-transmissible, MPXV DNA has been detected in blood samples.
Purpose of the Study:
- To evaluate the performance characteristics of a research use only (RUO) nucleic acid amplification test for MPXV.
- To assess the assay's suitability for detecting MPXV DNA in human blood donor plasma and serum specimens.
Main Methods:
- Sensitivity was determined using synthetic DNA, purified genomic DNA, and chemically inactivated virus.
- Specificity was assessed using plasma from blood donors during the mpox outbreak, including those at increased risk.
Main Results:
- The 95% limit of detection (LOD) ranged from 0.26 to 166.61 copies/mL depending on the target material.
- The RUO MPXV Assay demonstrated 100% specificity (95% CI, 99.93%-100.00%) with all tested donor samples being nonreactive.
Conclusions:
- The RUO MPXV Assay was developed as a potential screening tool for blood donations in response to the mpox outbreak.
- The assay exhibited high specificity, suggesting its utility for safeguarding blood donations.
