2141. Potential for Harm From Rapid Campylobacter Antigen Test: Quality Improvement Process Reveals 84% False-Positive STAT! Campy Stool Antigen Results

BACKGROUND: The Immunocard STAT! Campy is known to have a poor correlation with Campylobacter culture, and bloody stools are thought to be the most common cause of false-positive tests. A CDC investigation of 11 cases of Campylobacter in premature infants with non-bloody stools between March and April, 2018 at the Children’s Hospital of Illinois identified a pseudo-outbreak secondary to false-positive stool antigen tests. METHODS: Beginning May 1, 2018, Immunocard STAT! Campy (Meridian BioScience) positive stools from 14-hospitals in the OSF network were sent to the OSF System lab for confirmation prior to resulting in the medical record (MR). Stool was placed into Cary Blair media and a STAT! Campy stool antigen test was repeated in the OSF System Lab. BioFire GI Panel (GIP) PCR was performed on STAT! Campy positive stools, and results reported in the MR. RESULTS: Between May 1, 2018 and April 30, 2019, 3,639 stools were submitted for culture. 372 tested positive by the STAT! Campy rapid antigen test and were referred for confirmation. Repeat rapid antigen tests were negative for 56% (208/372) of stools and were finalled in the MR as negative without GIP testing. GIP PCR was performed on 164 samples from 163 patients (mean age = 18). 43% (71/164) of GIP were completely negative; 16% (27/164) positive STAT! Campy antigens were confirmed by the GIP (84% were false positive). Pathogens detected by the GIP included: 30 viral infections (50% Norovirus), 27 cases of C. difficile, and 19 pathogenic E. coli (Table 1). Multiple pathogens were detected in 15% (25/163) patients (1 patient was positive for 4 pathogens). One case of Salmonella was not detected by GIP. One patient tested negative by the GIP but remained symptomatic and C. difficile was detected on repeat testing 10 days later. CONCLUSION: C. difficile and Norovirus were the most common pathogens detected in stools that yielded false positive STAT! Campy results. These findings have important patient care and infection control implications. Currently neither FDA nor CDC requires Campylobacter culture (or other laboratory methods) of confirmation of positive Campylobacter stool antigen tests. Missed and incorrect diagnoses represent a significant risk of harm for patients (particularly C. difficile or Shiga toxin-infected patients, Table 1), and outbreaks in institutional settings. [Image: see text] DISCLOSURES: All authors: No reported disclosures.