B-244 BioCode® Gastrointestinal Pathogen Panel (GPP) Testing data over five years at a regional reference laboratory

Background Gastroenteritis is a leading cause of death worldwide across all age groups. It is estimated that 1.31 million people died from diarrheal disease in 2015. The BioCode® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous detection and identification of 17 targets including bacteria (Campylobacter, C. difficile toxin A/B, Salmonella, Shigella/enteroinvasive E. coli, enteroaggregative E. coli, enterotoxigenic E. coli, shiga toxin-producing E. coli, E. coli O157, Vibrio spp., Y. enterocolitica), viruses (Norovirus GI/GII, Adenovirus F, Rotavirus A), and parasites (Cryptosporidium, E. histolytica, G. lamblia). The BioCode® GPP is an FDA-cleared panel and was validated with KingFisher Flex (ThermoFisher), easyMAG (bioMerieux), and MagNA Pure 96 (Roche) systems. This is an observational statistical analysis of five years of BioCode® GPP testing data at Path AI Reference Laboratory (now Quest Diagnostics, Memphis), using the MagNA Pure 96 as the extraction method. Methods Retrospective data was abstracted from electronic records of patient samples tested with BioCode® GPP at Path AI Reference Laboratory. Data was analyzed and summarized as follows:Demographics (ages and genders, geographic distribution, sample types)Assay Results (positive and negative rates, coinfection, positives by pathogens and sample types, and invalid rates) Results A total of 82,032 patients from 50 states were tested with the BioCode® GPP at Path AI Reference Laboratory from April 2019 to March 2024. Female and male patients were 67% and 33%, respectively. Patients were grouped via the following age brackets: 0–5 years (2%), 6–21 years (6%), 22–59 years (43%), and 60+ years (49%). The positive rates for patients aged 0–5, 6–21, 22–59, and 60+ years was 49%, 20%, 17%, and 16% respectively. Sample types were fresh stool (78%), rectal swab (15%), and fecal swab (7%). The positive rates of fresh stool, fecal and rectal swabs were 17%, 17%, and 21%, respectively. Eighteen percent of patients were positive for at least one target, of which 57% were C. difficile positives. Of positive patients, 8% were positive for more than one target. Invalid rates were 4.5%, 0.7%, and 0.4% for fresh stool, rectal, and fecal swab, respectively. Conclusion The BioCode® GPP testing data from April 2019 to March 2024 offers key insights into patient demographics and results. The panel was used to test patients from all 50 states, with twice as many individuals identified as female versus male at birth. While more than 90% of patients were older than 22, children aged five and under had over twice the positivity rate of all other age groups. Eighteen percent of patients tested positive for at least one target. Both rectal and fecal swabs were valid sample types. Fresh stool and fecal swabs exhibited equivalent positivity rates, whereas rectal swabs showed a higher positivity rate than the other sample types. C. difficile emerged as the leading cause of gastroenteritis, responsible for more than half of all positive results. Additionally, rectal and fecal swabs demonstrated significantly lower invalid rates compared to fresh stool when evaluated on the BioCode® GPP.