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Updated: Aug 26, 2026
Antigen-Capture Enzyme-Linked Immunosorbent Assay for Specific Detection of Mycoplasma pneumoniae
Published on: February 24, 2023
Inactivation of mycoplasma species in blood by INACTINE PEN110 process
Boris Zavizion1, Andrei Purmal, John Chapman
1V. I. Technologies, Inc., Watertown, Massachusetts 02472, USA. boris.zavizion@vitechnologies.com
Background:
Mycoplasmas have been associated with multiple acute and chronic diseases. Mycoplasma genome is found in the blood of 10 to 15 percent of subjectively healthy individuals. If blood borne and viable in donated blood, mycoplasmas could potentially be transfusion transmissible. The INACTINE PEN110 technology is a pathogen reduction process that is in Phase 3 clinical studies. The present study investigated the ability of this process to eradicate mycoplasmas in human blood.
Study Design And Methods:
Identical whole blood or RBC units inoculated with Mycoplasma arthritidis or M. pneumoniae were incubated with PEN110 (inactivating agent) for 24 hours at 23 degrees C. Sham controls were treated with buffer under the same conditions. 4 degrees C controls were put on storage immediately after the spike.
Results:
No viable microorganisms were detected in PEN110-treated units after 24 hours of incubation. Sham controls showed no changes to mycoplasma titers during the incubation. In 4 degrees C controls, minor decrease of mycoplasma titers was observed during the storage.
Conclusion:
The INACTINE process inactivates more than 107 mycoplasma CFU per mL in whole blood and RBCs. This study is the first demonstration of susceptibility of mycoplasmas to pathogen reduction. The data provide further support for the ability of INACTINE technology to address microbial safety issues that are not well characterized.
Insights
The INACTINE PEN110 pathogen reduction process effectively inactivates mycoplasmas in human blood and RBCs. This study demonstrates the technology
Area of Science:
- Blood safety
- Microbiology
- Pathogen reduction technologies
Background:
- Mycoplasmas are linked to various diseases and can be present in healthy individuals' blood.
- Bloodborne mycoplasmas pose a risk of transfusion transmission.
- INACTINE PEN110 is a pathogen reduction technology in clinical trials.
Purpose of the Study:
- To evaluate the efficacy of INACTINE PEN110 in eradicating mycoplasmas from human blood.
- To assess the potential of this technology for improving blood safety.
Main Methods:
- Human whole blood and RBC units were inoculated with Mycoplasma arthritidis or M. pneumoniae.
- Units were treated with INACTINE PEN110 or a buffer control for 24 hours at 23°C.
- Refrigerated (4°C) controls were assessed during storage.
Main Results:
- No viable mycoplasmas were detected in PEN110-treated units after incubation.
- Sham controls showed no significant change in mycoplasma titers.
- A minor decrease in mycoplasma titers was observed in refrigerated controls during storage.
Conclusions:
- The INACTINE process inactivates >10^7 mycoplasma CFU/mL in whole blood and RBCs.
- This is the first study showing mycoplasmas are susceptible to pathogen reduction.
- INACTINE technology shows promise for addressing uncharacterized microbial safety concerns in blood products.
