Differentiation of biliary atresia using a rapid point-of-care matrix metalloproteinase-7 assay: A multicenter diagnostic study

BACKGROUND: Delayed diagnosis and surgery are the main causes of poor prognosis in biliary atresia (BA). This delay is frequently attributed to the complexity of current outpatient evaluation methods. While serum MMP-7 analysis via currently available methods, such as ELISA, offers high diagnostic accuracy, its utility in outpatient settings is often limited by turnaround time. To address this challenge, we developed and evaluated the MMP-7 Quick Test for accurately differentiating BA. METHODS: This multicenter prospective diagnostic study was conducted between November 2021 and December 2024 at the pediatric surgery outpatient departments of 5 tertiary centers. A total of 423 patients aged <6 months who presented with persistent jaundice were included. Samples collected from November 2021 to May 2023 were analyzed by ELISA (n=221) in batches once or twice weekly. From June 2023 to December 2024, samples were measured using the MMP-7 Quick Test (n=202), in which residual serum was tested individually with routine liver function tests. RESULTS: Among 202 infants evaluated using the rapid test, 98 were diagnosed with BA. The rapid test demonstrated a sensitivity of 91.84% (95% CI, 86.42%-97.26%), and a negative predictive value of 92.00% (95% CI, 86.68%-97.32%). These diagnostic parameters were comparable to the ELISA method, with a sensitivity of 90.82% and a negative predictive value of 91.74%. The rapid test provided results in 15 minutes at a cost of $14 per test, whereas the ELISA workflow required batch processing, taking an average of 3 days with a higher cost ($70). CONCLUSIONS: The MMP-7 Quick Test serves as a rapid, accurate, and cost-effective screening tool suitable for outpatient settings, thus facilitating the early diagnosis of BA.