394. Impact of Misdiagnosis of Clostridioides difficile Infection (CDI) by Standard-of-care Specimen Collection and Testing on Estimates of Hospitalized CDI Incidence Among Adults in Louisville, Kentucky, 2019-2020 (2022)

Abstract Background Public health surveillance indicates that there is a high population-based incidence of laboratory-confirmed hospitalized CDI cases in the United States. Although reported CDI cases are identified via standard-of-care (SOC) specimen collection and CDI testing practices, the impact of SOC misdiagnosis on the reported CDI incidence is uncertain. Methods Active surveillance from Oct 14, 2019, to Apr 11, 2020, identified inpatients aged ≥50 years with diarrhea (≥3 stools with Bristol score ≥5 in 24 hours) at all wards at 8 of the 9 adult hospitals in Louisville, Kentucky (population &amp;gt;50 years = 276 456). Study stool specimens from inpatients with diarrhea were screened by rapid GDH/toxin membrane enzyme immunoassay and the positive samples tested by PCR and cell cytotoxicity neutralization assay (CCNA). A study CDI case was a patient with PCR positive/CCNA positive stool or PCR positive stool with pseudomembranous colitis (PMC). Incidence (non-recurrent CDI cases/100 000 persons aged &amp;gt;50 years per year [PY]) was adjusted for the hospitalization share of participating hospitals and, in a sensitivity analysis, for patients with diarrhea without a CDI test result. SOC stool specimen CDI testing occurred independent of the study. Results Among 1541 inpatients with diarrhea, study testing identified 109 non-recurrent CDI cases; 18 (16.5%) had PMC, 36 (33.0%) were admitted to intensive care, and 21 (19.3%) died during the 90-day follow-up. Study hospitalized CDI incidence was 154/100 000 PY (202/100 000 PY in the sensitivity analysis). SOC hospitalized CDI incidence was 121/100 000 PY. Of the 109 study CDI cases, 44 (40%) were not SOC-diagnosed (SOC under-diagnosis). Of the 75 SOC CDI cases that also had study testing, 12 (16%) were not study CDI cases (SOC over-diagnosis). SOC-undiagnosed and SOC-diagnosed CDI cases had similar demographics, medical histories, and clinical outcomes. Study testing identified 24% more CDI cases than SOC testing. Conclusion There was a high incidence of hospitalized CDI in persons aged &amp;gt;50 years (154-202/100,000 PY). Of the hospitalized CDI cases, one-third were admitted to ICU and one-fifth died. Public health surveillance estimates of the incidence of laboratory-confirmed hospitalized CDI cases, which are based on SOC testing, may be under-estimated by 24%. Disclosures Frederick Angulo, DVM PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Joann M. Zamparo, MPH, Pfizer: Employee|Pfizer: Stocks/Bonds Elisa Gonzalez, MPH, Pfizer: Employee|Pfizer: Stocks/Bonds Pingping Zhang, MS, Pfizer: Employee|Pfizer: Stocks/Bonds Michael W. Pride, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Sharon Gray, MPH, Pfizer: Employee|Pfizer: Stocks/Bonds Catia Matos Ferreira, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Forest W. Arnold, DO, MSc, Gilead Sciences, Inc.: Grant/Research Support Raul E. Isturiz, MD, Pfizer: Employee|Pfizer: Stocks/Bonds Nadia Minarovic, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Jennifer Moisi, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Luis Jodar, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds.