摘要Globally,approximately 10 million new tuberculosis(TB)cases are reported annually.Delayed diagnosis due to low detec-tion rates is the primary cause of mortality.Although pathological examination is commonly used for diagnosing TB,5%-30%of cases remain undiagnosed,emphasizing the urgent need to establish quality control(QC)standards to reduce rates of misdiagnosis and missed diagnoses.To address this,we introduced a novel QC chip for detecting Mycobacterium tuberculo-sis(MTB).A quantitative pathological QC model was constructed by precisely and uniformly integrating MTB and HeLa cells into a photocurable hydrogel.This model was then sliced into uniform sections to create QC chips.It demonstrated that the QC chips exhibited no significant differences in intra-batch or inter-batch variation(coefficient of variation<5%),and re-mained stable at-80 ℃ for one year.Furthermore,these chips were found to be 100%effective when tested with 240 clini-cal samples(200 with special staining and 40 with polymerase chain reaction).In addition to enhancing TB detection rates,this approach offers visualization,quantification,and sustainable production.Overall,this work provides a novel framework for developing QC chips for pathological testing,offering a reliable solution to enhance clinical diagnostic workflows.
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