Development of a Laboratory Verification Protocol for Concurrent Detection of Bacterial, Fungal, and Antimicrobial Resistance Genes in a Multiplex Syndromic Joint Infection Panel
Performance verification is a critical component of implementing a diagnostic test in a clinical lab and can be time consuming and costly. A verification protocol and organism panel were developed in collaboration with ZeptoMetrix ® to verify all analyte detections for the BioFire ® Joint Infection (JI) Panel*. The proposed BioFire Joint Infection Panel detects 31 potential pathogens and 8 potential antimicrobial resistance (AMR) genes associated with joint infections from synovial fluid specimens.
A protocol was developed using pilot NATtrol controls from ZeptoMetrix ® synovial fluid, and the BioFire ® FilmArray ® 2.0 and the BioFire ® FilmArray ® Torch Systems Control materials were tested in the presence of synovial fluid from pooled human donors Synovial fluid was characterized for Joint Infection Panel targets by screening the specimen on the BioFire Joint Infection Panel prior to starting the verification procedure The 32 targets required for all analyte detections were divided into 5 pools of 6 to 7 analytes and then tested over multiple days on several systems.
*For research use only not for use in diagnostic procedures.
ZeptoMetrix® NATtrol Joint Infection Panel is packaged to allow maximum flexibility for laboratory validation and QC needs:
NATJIP-BIO- Joint Infection Verification Panel (32 x 0.2 mL, 5 x 1.4 mL)
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