Clinical validation of serum immunosignatures in early diagnosis of Crohn's disease

Background:The search for biomarkers suitable for early diagnosis of Crohn's disease(CD)is challenging.This study investigated the efficacy of serological markers for the early diagnosis of CD.Methods:This was a retrospective nested cohort study.Indirect immuno-fluorescence and enzyme‐linked immunosorbent assay were used to detect ASCA IgG,ASCA IgA,AYMA IgG,AYCA IgG,FI2Y IgG,p‐ANCA IgG,GAB IgG and PAB IgG in patient serum samples.Results:The positive rates of ASCA IgG,ASCA IgA,AYMA IgG,AYCA IgG,FI2Y IgG,p‐ANCA IgG,GAB IgG and PAB IgG in patients with early CD,advanced CD and other intestinal diseases were 37.0%versus 56.8%versus 27.8%;3.7%versus 20.5%versus 19.4%;14.8%versus 2.3%versus 2.8%;25.9%versus 9.1%versus 8.3%;18.5%versus 15.9%versus 8.3%;0.0%versus 2.8%,18.5%;13.6%versus 18.2%versus 16.7%;and 7.4%versus 20.5%versus 0.0%,respectively.The positive rates of ASCA IgG,AYCA IgG and PAB IgG were significantly different among the three groups(p<0.05).In 85.2%of early CD patients,at least one antibody was detected 1 year before diagnosis.The sensitivity of the ASCA/AYMA/AYCA/FI2Y/GAB combination for early diagnosis was 85.2%.The sensitivity of the ASCA/AYMA/AYCA/FI2Y/GAB/PAB/PANCA combination for differentiating CD from other diseases was 87.3%.Conclusions:ASCA IgG and AYCA IgG have potential value in identifying the course of CD.AYCA IgG may be a potential marker for the early diagnosis of CD,and ASCA IgG indicates an advanced stage.The combination of ASCA,AYMA,AYCA,FI2Y,and GAB improves early diagnostic accuracy of CD.

Comparison of an automated digital cell morphology analysis system with manual counting

Background:Bionovation's CSFA800 is a new automated digital cell imaging analyzer.We evaluated the performance of the CSFA800 by comparing it with artificial peripheral blood white blood cell counting.Methods:According to inclusion and exclusion criteria,131 randomly selected samples(77 abnormal samples and 54 normal samples)were compared.Correlations between automated and manual counting results were analyzed.Manual counting was carried out according to the guidelines of the Association of Clinical and Laboratory Standards.Results:Counts of neutrophils,lymphocytes,monocytes,eosinophils,baso-phils,and immature granulocytes obtained from CSFA800 and artificial methods were linearly and positively correlated,with R values of 0.73,0.65,0.24,0.2,0.4,and 0.63,respectively,all p<0.05.Therefore,correlations be-tween CSFA800 and manual counting are acceptable.Compared with the DI‐60 Automated Digital Cell Morphology System(DI‐60;Sysmex),CSFA800 is more efficient and can analyze 20,000 cells in 1 min.However,the overall accuracy of CSFA800 is not as good as DI‐60,although its counting perfor-mance is better for basophils.Conclusions:The performance of CSFA800 for WBC counts is acceptable,and it displayed good performance for neutrophils,lymphocytes,and imma-ture granulocytes.Compared to DI‐60,CSFA800 is more efficient but has slightly lower overall accuracy.To some extent,CSFA800 is helpful to opti-mize the clinical laboratory workflow and improve the working efficiency of inspectors.