Performance characteristics and optimal cut-off value of triple adenylate nucleotides test versus adenosine triphosphate test as point-of-care testing for predicting inadequacy of duodenoscope reprocessing.

ABSTRACT

BACKGROUND: Adenosine triphosphate (ATP) test based on one nucleotide has been applied as point-of-care testing (POCT) for bacterial contamination in the medical and food industries. Hypothetically, testing three adenylate nucleotides (A3) may provide better detection of duodenoscope bacterial contamination than ATP test. AIM: To evaluate performance characteristics and optimal cut-off value of A3 and ATP tests in predicting bacterial contamination of duodenoscopes. METHODS: Four hundred duodenoscope samples obtained after 100 endoscopic retrograde cholangiopancreatography procedures were randomized into group A (A3 test) or B (ATP test). Samples were collected from the elevator at the four-step cleaning process of duodenoscope. We defined the new cut-off value of the test for reaching 100% negative predictive value (NPV) from our receiver operating characteristic (ROC). FINDINGS: Using the cultures from the four-step cleaning process as the reference, the areas under ROC (AUROC) were 0.83 and 0.84 for group A (N = 200) and group B (N = 200), respectively. Using the cultures from post-high-level disinfection (HLD) as the reference, the AUROC were 0.35 and 0.74 for group A (N = 50) and group B (N = 50), respectively. We investigated ATP as a POCT after HLD with a new cut-off value of 40 RLU. However, this threshold did not allow detection of low numbers of bacteria. CONCLUSION: A3 and ATP tests provide good performances in predicting bacterial contamination of duodenoscopes for the four-step cleaning process. The ATP <40 RLU is helpful as a POCT after HLD; however, the limitation of this cut-off value is its inability to detect low numbers of bacteria.