Multiplex Polymerase Chain Reaction Panels for Gastrointestinal Infections: Current Evidence, Regulatory Hurdles, and the Way Forward
Giannoula S. Tansarli, David R Allen, Ferric C. Fang
Abstract
Syndromic multiplex polymerase chain reaction (PCR) panels have revolutionized the diagnosis of gastrointestinal infections, allowing the rapid and simultaneous detection of multiple pathogens, including rare or difficult-to-identify organisms, with superior analytic sensitivity as compared with conventional methods. Although multiplex PCR panels are costly, their costs are offset by lower health care costs resulting from improved diagnostic accuracy and more targeted therapy. However, significant barriers to reimbursement may discourage providers from ordering PCR panels or incentivize them to use smaller panels that are less comprehensive. Addressing these challenges will require a collaborative effort, including regulators, payors, and clinicians. Key steps will include updating clinical guidelines to better define appropriate utilization of gastrointestinal panels, harmonizing reimbursement criteria to align with evidence-based practice, and modernizing diagnostic codes for acute gastroenteritis to match payors' requirements. These reforms will be essential to improve access to advanced diagnostics and ensure better patient care.