Hypocholesterolemia and Inflammatory Biomarkers Act as Predictors of Severe Vitamin D Deficiency in Patients With Crohn's Disease: A Clinical Analysis of 862 Patients in China.

Background: In this study, we enrolled 862 patients with Crohn's disease (CD) in China to investigate the correlation between serum vitamin D (SVD) and serum lipids, inflammatory biomarkers, and important clinical parameters. Materials and Methods: 25(OH)D was measured by LS/MS/MS. Correlation analysis, chi-square tests, and logistic regression analysis were performed to determine the correlations between vitamin D and potential risk factors when vitamin D levels were lower than 10 ng/mL or 20 ng/mL. Results: The incidence of severe vitamin D deficiency (SVD < 10 ng/mL) in patients with CD was significantly higher than that in healthy controls (28.9 vs. 9.5%). Multinomial logistic regression analysis showed that penetrating disease [odds ratio (OR) = 2.18], low levels of high-density lipoprotein cholesterol (HDL) (OR = 1.91), high erythrocyte sedimentation rate (OR = 1.73), and platelet count (PLT) (OR = 2.71) were regarded as predictors of severe vitamin D deficiency, while only PLT (OR = 1.90) and HDL (OR = 1.76) were considered as predictors of mild vitamin D deficiency (SVD 10-20 ng/mL). Conclusion: Our results confirm a higher incidence of severe vitamin D deficiency in patients with CD in China and show that vitamin D deficiency could result from the combined effects of penetrating disease, inflammation, and low levels of HDL.

Mass SARS-CoV-2 molecular and serological screening of medical staff and patients in Hangzhou, China: no evidence of RNA detection, low seroprevalence, and limited exposure risk in the hospital setting.

BACKGROUND: To assess and limit the SARS-CoV-2 exposure risk from symptomless individuals in the hospital setting, molecular and serological screening of staff and patients attending a tertiary hospital in China was conducted. METHODS: SARS-CoV-2 RNA was tested by quantitative RT-PCR. Anti-SARS-CoV-2 IgM and IgG were screened initially with two lateral flow immunoassays (LFIs) and further confirmed with three chemiluminescence immunoassays (CLIAs). The assay performance was assessed using archived samples from 32 confirmed COVID-19 cases and 80 healthy individuals. RESULTS: Between April 24 and May 8, 2020, 16,043 subjects (7,392 medical staff, 4,714 inpatients, 1,209 chaperones, 1,705 outpatients, and 1,023 fever clinic patients) were screened. No subject tested positive for viral RNA. Seventy-three (0.46%) tested positive for IgM or IgG on the initial LFI screening, of whom 63 were investigated with CLIAs: 2 (0.01%) were confirmed as seroreactive and 18 (0.11%) were indeterminate. Unconfirmed seroreactivity was significantly more frequent in fever clinic patients. The CLIAs showed similar (95.0-100%) IgM or IgG specificity but higher IgG sensitivity (93.75-96.88% vs. 31.25-81.25%) than the LFIs. The confirmed seropositive cases included a previously discharged COVID-19 patient and an undiagnosed symptomless patient showing detectable IgM and IgG over 35 days of follow-up. No transmission was evidenced within the corresponding family cluster. CONCLUSIONS: Low SARS-CoV-2 prevalence and limited exposure risk were observed. Seroprevalence varied between 0.012% and 0.12% according to the testing algorithm and the confirmation criteria used, indicating that quality standards for serological tests are needed. Protective immunity in asymptomatic COVID-19 patients who recovered needs to be investigated further, but the associated risk of transmission appeared limited.

Measurement of HE4 and CA125 and establishment of reference intervals for the ROMA index in the sera of pregnant women.

INTRODUCTION: Cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) are biomarkers for ovarian cancer. Their specificity and sensitivity are often limited during pregnancy as a result of great fluctuations. The risk of ovarian malignancy algorithm (ROMA) score, which combines CA125, HE4, and menopausal status, may improve diagnostic performance. There are no reports regarding the ROMA index in pregnant women. Therefore, the aim of our study was to establish appropriate reference intervals (RIs) for the ROMA index in pregnant Chinese women and compare them with those of CA125 and HE4 during pregnancy. METHODS: Serum concentrations of CA125 and HE4 were simultaneously measured in healthy pregnant women via electrochemiluminescence immunoassay (ECLIA). The ROMA index was calculated using premenopausal algorithms. RESULTS: The RIs for the ROMA index calculated by premenopausal algorithms were substantially closer to the normal range in the first 2 trimesters. For pregnant women, the great misclassifications identified in CA125 may be reversed by the use of ROMA index. CONCLUSIONS: We established the RIs for HE4 and CA125, as well as the ROMA index, in pregnant women at different gestational periods. The ROMA index is suggested to be a more promising tumor marker for pregnant women diagnosed with malignance.

Performance of the Sysmex UF-1000i urine analyser in the rapid diagnosis of urinary tract infections in hospitalized patients.

BACKGROUND: Urinary tract infections (UTIs) are the second most frequently encountered nosocomial infectious diseases, and they greatly increase the cost of medical care and prolong the duration of hospital stays. AIM: We aimed to evaluate the performance of the Sysmex UF-1000i analyser for the rapid prediction of UTIs in hospitalized patients with or without indwelling catheters at a comprehensive teaching hospital that encounters complex disease types. METHODS: Urine specimens (n = 1016) were cultured and examined for WBC, RBC, bacteria (BACT) and yeast-like cell (YLC) count using the Sysmex UF-1000i. The results were compared with the urine culture results. Receiver operating characteristic curve analysis was applied to determine BACT and YLC cutoff values for bacterial and fungal UTIs independently. The diagnostic ability of the UF-1000i was also compared for patients with and without indwelling catheters. FINDINGS: A cutoff value of 38.7/µL was acceptable for ruling out bacterial UTIs. In this setting, we achieved a sensitivity of 90%, a negative predictive value of 94.5%, a false negative rate of 2.85% (29 cases), and avoided culturing in 52% of the samples. The BACT count presented a larger area under the curve for patients with indwelling catheters than for those without (0.939 vs. 0.861); however, no significant difference in the diagnostic ability of the two curves was found. CONCLUSION: The Sysmex UF-1000i analyser could be a reliable method for excluding bacterial UTIs in hospitalized patients with or without urinary catheters and could help clinicians determine whether antibiotic therapy is necessary.

The levels of carbohydrate antigen 19-9 are associated with gender and age in Chinese population.

BACKGROUND: CA 19-9 is one of the most frequently used biomarkers for tumors. METHODS: We analyzed the influential factors of the Carbohydrate Antigen 19-9 (CA 19-9) levels in Chinese general population to better interpret the results of the CA 19-9 screening tests. 36,924 apparently healthy individuals and 1,335 patients with gastrointestinal (GI) tumors were involved in this study. Serum CA 19-9 levels were measured using a Roche Cobas E601. RESULTS: The serum CA 19-9 levels in apparently healthy individuals were correlated with age and gender. Its level was positively correlated with the age of males, while it showed a V-shape curve in female populations. This effect could be due to sex hormones, such as prolactin, which were found to have a negative effect on the level of CA 19-9 in the present study. CONCLUSIONS: Our data indicates that gender and age could affect the CA19-9 serum level. We can set up different cut-off values according to the patient's gender and age, which can help us to get a more individualized representation in different populations.