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Performance profile of an updated safety measure rapid assay for bacteria in platelets
Remo P Vallejo1, Lisa Shinefeld1, David LaVerda1
1Research and Development Department, Verax Biomedical Incorporated, Worcester, Massachusetts, USA.
Background:
The Verax PGD rapid test for bacteria in platelets (PLTs) has been updated to simplify workflow and improve specificity and sensitivity by employing a novel sequential format. The performance of this updated version, called PGDprime, was evaluated to determine its suitability for use as an FDA-cleared "safety measure" to supplant the current PGD test.
Study Design And Methods:
Three consecutive cGMP-manufactured lots of PGDprime were evaluated for specificity (at three separate sites), sensitivity, reproducibility, interfering substances, assay robustness, and detection in analytical growth and ultralow-inoculum growth studies. PGDprime's performance was compared to that of PGD.
Results:
Specificity studies yielded no false-positive results among 3802 individual indate PLTs of seven different types (observed specificity, 100%). PGDprime detected all 10 PGD claim bacteria at the same limit of detection or better. Wild-type Gram-negative bacteria growing in PLTs were detected at earlier elapsed times than PGD by 12 to 30 hours. In growth studies, PGDprime detected bacteria growing in PLTs within the same 12-hour interval as PGD or 12 to 48 hours earlier. Assay reproducibility was not affected by operator, day of test, or manufacturing lot. PGDprime tolerated a wide variation in volume transfers, timing, temperature, and relative humidity and was not affected by 15 of 16 potential interferents found in samples at extremely high or low levels.
Conclusion:
The PGD test has been successfully updated to PGDprime with an innovative sequential assay format to deliver a robust simplified workflow and improved specificity and sensitivity.
Insights
The updated Verax PGDprime rapid test for bacteria in platelets (PLTs) offers improved specificity and sensitivity. This new test simplifies workflow and detects bacterial contamination earlier than the previous PGD test.
Area of Science:
- Medical Diagnostics
- Microbiology
- Blood Safety
Background:
- The Verax PGD rapid test for bacteria in platelets (PLTs) has been a key tool for ensuring blood product safety.
- An updated version, PGDprime, was developed to enhance workflow, specificity, and sensitivity.
Purpose of the Study:
- To evaluate the performance of the updated PGDprime test.
- To determine its suitability as an FDA-cleared safety measure to replace the current PGD test.
Main Methods:
- Three cGMP-manufactured lots of PGDprime were tested for specificity, sensitivity, reproducibility, and robustness.
- Performance was assessed across multiple sites and compared directly to the existing PGD test.
- Interfering substances and growth studies were conducted to evaluate detection capabilities.
Main Results:
- PGDprime demonstrated 100% specificity with no false positives in 3802 samples.
- It detected all target bacteria at or better than the PGD test's limit of detection.
- Bacterial contamination was detected 12-48 hours earlier than with the PGD test, with high reproducibility and robustness.
Conclusions:
- The PGDprime test represents a significant improvement over the PGD test.
- Its innovative sequential assay format provides a simplified workflow with enhanced specificity and sensitivity.
- PGDprime is a robust and reliable option for bacterial detection in platelets.
