Overview
Between April 2019 and March 2024, 82,032 patients across 49 U.S. states were tested using the BioCode® Gastrointestinal Pathogen Panel (GPP) at Path AI Reference Laboratory (Quest Diagnostics, Memphis). This large-scale dataset provides valuable insights into gastrointestinal infection trends, sample collection method performance, and diagnostic assay performance.
U.S. Nationwide Analysis · 2019–2024
82,032
Patients
Tested
49
U.S.
States
5 Yrs
Sample
Data Set
17
Targets
Multiplex Panel
Sample Types & Positivity Rates
Which GI Molecular Diagnostic Sample Type Performed Best?
Three specimen collection methods were evaluated. As illustrated in the chart below, fresh stool samples represent the predominant specimen type collected for GI panel testing.
Positivity rates and result reliability differ meaningfully across collection methods. An invalid rate measures how often a sample fails its internal quality control triggering a rerun, delaying results, and adding cost. The table below shows both metrics side by side.
| Sample Type | Positivity Rate | Invalid Rate |
|---|---|---|
| Rectal Swab (At Clinic)* | 21% | 0.7% |
| Fresh Stool | 17% | 4.5% |
| Fecal Swab (At Home)** | 17% | 0.4% |
* Sample collected at clinical site by a healthcare provider (Rectal sample has not been cleared by the FDA 510(k))
** Sample collected at home by the patient
GI Pathogen Detection
Which of the 17 GI Pathogens Were Detected Across a Five-Year Period with the BioCode® Gastrointestinal Pathogen Panel (GPP)?
Of the 82,032 samples tested, 17.6% were positive for at least one GI panel target and every single one of the GI panel’s 17 pathogens was detected at least once across the five-year study. Approximately 8% of positive samples demonstrated co-infections, detectable only with a multiplex panel. The chart below quantifies detections across all 17 GI pathogen panel targets.
Key Takeaways
What Does This Mean for Your Lab?
Rectal swabs showed the highest GI pathogen detection and most reliable results, while fresh stool samples had more invalid results due to inhibitory failures. Multiplex testing also identified co-infections that single-plex testing may miss, with all 17 BioCode® Gastrointestinal Pathogen Panel (GPP) targets detected during the study.
See the BioCode® GPP in Action