Liver function testing on the Abaxis Piccolo Xpress: Use in Ebola virus disease protocols

Healthcare settings evaluating patients for Ebola virus disease (EVD) require reliable liver function testing. Traditional laboratory methods may not be suitable for point-of-care use in high-containment environments. Prior research has shown that CLIA-waived systems can offer flexibility in such contexts, but few have been evaluated for EVD protocols. The need for a portable, accurate, and biosafe system remains unmet. This gap motivated the assessment of the Piccolo Xpress analyzer for liver function testing. The system’s performance in a BSL-2 environment is a key uncertainty. No prior work had resolved the compatibility of this device with EVD protocols. This study aimed to bridge that knowledge gap.

The study aimed to evaluate the analytical performance of the Piccolo Xpress for liver function testing in EVD protocols. A CLIA-waived system was chosen to support point-of-care diagnostics in biosafety-restricted settings. The researchers sought to confirm the device’s accuracy, precision, and stability across specimen types. They also aimed to assess pipette reliability and instrument airflow. The motivation stemmed from the lack of suitable point-of-care options for EVD diagnostics. The study focused on ensuring the device could meet biosafety standards. The researchers wanted to validate its use in a BSL-2 cabinet within a BSL-3 suite. The goal was to provide a reliable alternative for liver function testing in high-risk environments.

The study used the Liver Panel Plus reagent discs on the Piccolo Xpress analyzer to assess instrument performance. Precision, linearity, and accuracy were evaluated through repeated testing. Reference intervals were verified using pre-programmed values. Multiple specimen types, including whole blood and plasma, were tested for compatibility. Stability of analytes over time was assessed using lithium-heparin whole blood. Disposable pipettes were tested for volume transfer accuracy. Airflow was measured to determine biosafety compliance. The device was placed in a BSL-2 cabinet for final validation.

The Piccolo Xpress showed acceptable linearity with slopes ranging from 0.938 to 1.061. Precision was within acceptable ranges, with %CV values from 0.0 to 5.6%. Method comparison with Roche analyzers showed strong correlation for most assays. However, alkaline phosphatase and amylase showed notable differences. Reference intervals were verified except for alkaline phosphatase and alanine aminotransferase. Specimen type comparisons revealed minor differences for aspartate aminotransferase and total protein. Whole blood stability was observed for albumin and amylase. Airflow studies supported instrument placement in BSL-2 cabinets.

The Piccolo Xpress demonstrated analytical performance suitable for liver function testing in EVD protocols. The device met CLIA-waived standards for precision and linearity. Reference intervals were largely consistent, with exceptions noted for specific enzymes. Specimen type compatibility was confirmed, though minor differences were observed. Whole blood showed stability for some analytes but not all. Disposable pipettes were found to be effective for disc loading. Airflow studies justified placement in BSL-2 cabinets. The device was successfully integrated into the hospital’s diagnostic protocol for EVD.