Routine blood donor screening on a new NAT platform

Background

According to the German guidelines all blood donations must be screened for transfusion-relevant viruses by nucleic acid amplification testing (NAT). In June 2022, a new high-throughput, fully automated NAT platform called PoET Instrument (GFE) running CE-IVD PCR-based assays was introduced. In this study, we used this new platform to test minipools of whole blood and apheresis donor plasma samples for the presence of HCV, HBV, HIV-1/-2, HAV and B19V.

Methods

NAT screening of the blood donations was performed in minipools of up to 96 EDTA-Plasma samples. On the PoET Instrument three-times 1.3 ml plasma of each pool was extracted followed by PCR amplification (real-time RT-PCR) and detection. CE-IVD PCR assays (PoET HCV, PoET HBV, PoET HIV, PoET HAV, PoET B19V) were used. Analytical sensitivity (95% LoD) according to manufacturer information for detection of HCV, HBV, HIV, HAV and parvovirus B19 is 9.1 IU/ml, 1.6 IU/ml, 15 IU/ml, 0.9 IU/ml, and 8.6 IU/ml, respectively. In a routine setting, up to 1,440 donor samples per run were tested for 5 viruses within 3.5 hours. Result evaluation was performed by the system (Calliope Management Software).

Results

From June 2022 to April 2023, a total of 525,276 donations in 7,174 pools were tested. 97.4 % of the runs were successfully completed. In valid test runs, 99.8 % of the test results were valid. Inhibition rates for each PCR test were between 0.01% (PoET HBV) and 0.1% (PoET HIV). Rates of initially positive, not confirmed pools were between 0% (PoET HCV, PoET HAV) and 0.24% (PoET HBV).

Conclusion

Our experience with a total 10 months of testing demonstrates that the new PoET screening platform is a sensitive and robust system for routine infection screening of blood donors.

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