An Immunochromatographic Test Strip for Rapid Quantitative Control of Monoclonal Antibodies against Programmed Cell Death Protein 1.

Cancer is one of the major public health challenges in the world, which is characterized by rapid progression and high mortality. Immunotherapy, represented by PD-1 monoclonal antibody, has significantly improved the efficacy of malignant tumors and has become one of the most popular immunotherapy methods at present. Therefore, there is an increasing demand for novel detection methods for PD-1 monoclonal antibodies. The aim of this work was to establish a rapid, simple, and sensitive immunochromatographic test strip (ICTS) based on the AuNPs enlargement for both visual and instrumental detection of the PD-1 monoclonal antibody concentration. The mixed solution of NH2OH·HCl and HAuCl4 was used as an enhancement solution to lower the detection limit and achieve higher sensitivity. A test strip reader was used to construct a visualized quantitative detection standard curve for the PD-1 monoclonal antibody concentration. The LOD was 1.58 ng/mL through a triple signal-to-noise ratio. The detection time was within 10 min. The constructed test strips can rapidly, accurately, and efficiently detect the concentration of PD-1 monoclonal antibody in real samples.

High Prevalence of and Risk Factors for Latent Tuberculosis Infection among Prisoners, Tianjin, China.

The high incidence of tuberculosis (TB) among prisoners calls for interventions to identify latent tuberculosis infection (LTBI) before disease onset. To identify LTBI prevalence among prisoners and factors associated with it, we conducted a cross-sectional study in Tianjin. We randomly sampled 959 HIV-negative adult prisoners by ward clusters in 5 prisons and determined LTBI by seropositivity using an interferon-γ release assay. The overall rate of LTBI was 52.0% (499/959) in the 5 facilities and ranged from 41.9% (72/172) to 60.9% (106/174). Age (adjusted odds ratio [aOR] 1.7, 95% CI 1.4-2.0 per 10 years), duration of imprisonment (aOR 1.2, 95 CI% 1.1-1.2 per year), previous incarceration (aOR 2.0, 95% CI 1.5-2.7), and facility-specific TB incidence (aOR 1.9, 95% CI 1.3-2.8) were risk factors for LTBI. These findings indicate possible TB transmission within prisons and suggest the necessity for early TB case detection, as well as prophylaxis.

Later emergence of acquired drug resistance and its effect on treatment outcome in patients treated with Standard Short-Course Chemotherapy for tuberculosis.

BACKGROUNDS: The failure of current Standard Short-Course Chemotherapy (SCC) in new and previously treated cases with tuberculosis (TB) was mainly due to drug resistance development. But little is known on the characteristics of acquired drug resistant TB during SCC and its correlation with SCC failure. The objective of the study is to explore the traits of acquired drug resistant TB emergence and evaluate their impacts on treatment outcomes. METHODS: A prospective observational study was performed on newly admitted smear positive pulmonary TB (PTB) cases without drug resistance pretreatment treated with SCC under China's National TB Control Program (NTP) condition from 2008 to 2010. Enrolled cases were followed up through sputum smear, culture and drug susceptibility testing (DST) at the end of 1, 2, and 5 months after treatment initiation. The effect factors of early or late emergence of acquired drug resistant TB , such as acquired drug resistance patterns, the number of acquired resistant drugs and previous treatment history were investigated by multivariate logistic regression; and the impact of acquired drug resistant TB emergence on treatment failure were further evaluated. RESULTS: Among 1671 enrolled new and previously treated cases with SCC, 62 (3.7%) acquired different patterns of drug resistant TB at early period within 2 months or later around 3-5 months of treatment. Previously treated cases were more likely to develop acquired multi-drug resistant TB (MDR-TB) (OR, 3.8; 95%CI, 1.4-10.4; P = 0.015). Additionally, acquired MDR-TB cases were more likely to emerge at later period around 3-5 months after treatment starting than that of non-MDR-TB mainly appeared within 2 months (OR, 8.3; 95%CI, 1.7-39.9; P = 0.008). Treatment failure was associated with late acquired drug resistant TB emergence (OR, 25.7; 95%CI, 4.3-153.4; P < 0.001) with the reference of early acquired drug resistant TB emergence. CONCLUSIONS: This study demonstrates that later development of acquired drug resistant TB during SCC is liable to suffer treatment failure and acquired MDR-TB pattern may be one of the possible causes.

[Treatment effect analysis of the standard regimen and the optimized regimen for retreatment pulmonary tuberculosis complicated with diabetes].

OBJECTIVE: To analyze the therapeutic effects of the standard regimen and the optimized regimen in retreatment pulmonary tuberculosis complicated with diabetes mellitus (DM). METHODS: In a multi-center cohort study, patients with smear positive retreatment pulmonary tuberculosis (TB) with DM and those without DM [excluding multi-drug resistance (MDR), extensively drug-resistant (XDR) and non-tuberculosis Mycobacterium pulmonary disease(NTM)] were enrolled. There were a total of 178 cases, including 60 smear positive retreatment TB patients with DM and 118 without DM, who were randomly divided into 4 groups: Optimized group 1 [individualized treatment in 30 DM cases, 29 males, age (48 ± 11)], retreatment group 1 [standard retreatment regimen in 30 DM cases, 28 males, age(48 ± 10)], Optimized group 2[individual regimen in 57 non-DM cases, 37 males, age (41 ± 14)], and retreatment group 2 [standard retreatment regimen in 61 non-DM cases, 49 males, age (43 ± 13)]. Patients in the optimized group were treated with optimized individualized regimen based on DST result, with 3-4 sensitive drugs in the regimen, while those in the retreatment group were treated with national standard retreatment regimen. The therapeutic effect of different groups were recorded and the related factors of treatment outcome were analyzed with Chi-square test and multi-factor analysis. RESULTS: The treatment success rates of the optimized group 1 and the retreatment group 1 were 83.3%(25/30) and 60.0%(18/30), respectively, and the difference was statistically significant (χ(2)=4.02, P=0.045<0.05). The treatment failure rate of the optimized group 1 (6.7%, 2/30) and the retreatment group 1(30.0%, 9/30) was statistically different (χ(2)=5.46, P=0.02<0.05). The outcome difference between the optimized group 2 and the retreatment group 2 showed no statistical significance. Multi-factor analysis showed that treatment regimen, DM, gender and drug resistance were the significant factors related with treatment outcome. The probability of treatment success using the individualized treatment regimen was 2.7 times higher than that using the standard regimen (P=0.025). The risk of treatment failure of the drug resistance cases was 2.8 times higher than that of the drug sensitive cases (P=0.038). The probability of treatment success in DM cases was 0.4 times that in non-DM cases (P<0.05). CONCLUSION: The outcome of the optimized regimen group was better than that of the standard regimen group, and retreatment TB patients complicated with DM faced a higher risk of treatment failure, which should receive more attention.

Insight to the Epidemiology and Risk Factors of Extrapulmonary Tuberculosis in Tianjin, China during 2006-2011.

BACKGROUND: The proportion of extrapulmonary tuberculosis (EPTB) among all the reported tuberculosis (TB) cases has increased in different populations. Despite the large burden of TB in China, the epidemiology of EPTB in China remains largely understudied and the risk factors for having EPTB diagnosis in China have not been identified. METHODS: To gain insight to EPTB epidemiology in China, we analyzed TB surveillance data collected in Tianjin, China, during 2006 to 2011. The frequency of EPTB among all TB cases and within different socio-demographic groups of the study patients aged 15 years and older was determined for EPTB in general and by specific types. The distribution of socio-demographic characteristics was compared between pulmonary TB (PTB) group and EPTB group by chi-square test. Crude and multiple logistic regression-derived adjusted odds ratios (aOR) and 95% confidence intervals (CI) were determined to assess the associations between having EPTB diagnosis and each individual explanatory variable in question. RESULTS: About one-tenth (1,512/14,561) of the patients investigated in this study had EPTB. Of these 1,512 EPTB cases, about two thirds were pleural TB. Significant difference in age, occupation, and urbanity of residence were found between PTB and EPTB groups (p<0.05). Patients with EPTB diagnosis were more likely to be 65 years or older (aOR = 1.22, 95% CI: 1.02, 1.46), to be retired (aOR = 1.37, 95% CI: 1.08, 1.75), and to live in urban areas (aOR = 1 38, 95% CI: 1.22, 1.55). CONCLUSIONS: The findings of this study extends the knowledgebase of EPTB epidemiology in developing countries and highlight the need for improved EPTB detection in China, especially in subpopulations with high risk for EPTB or having limited access to medical facilities with adequate capacity for EPTB diagnosis.