1.Study on verification and evaluation for the performance of a nucleic acid test system of screening blood
Wengong DU ; Xinghuan MA ; Peng YIN ; Peipei WANG ; Juan LIU
China Medical Equipment 2024;21(10):19-23
Objective:To evaluate main performance indexes and application value of a domestic blood nucleic acid test system for blood screening,so as to ensure the safety of blood screening in the system of blood bank.Methods:Twenty samples were selected from Langfang Center Blood Bank in January 2022,and 6703 blood specimens of voluntary blood donors from Langfang Blood Bank between 2022 and 2023 were simultaneously selected.According to the requirements of the"Technical Operating Procedures for Blood Stations(2019 Edition)"and the standard for medical medicine industry"Nucleic Acid Amplification Test Reagents(kits)",the performances of stability,analytical specificity,sensitivity,precision,anti-interference ability and against cross-contamination ability of nucleic acid test system were verified for the analysis of clinical application.Results:The coincidence rate of the nucleic acid test system was 100%for 20 negative plasma samples.The coincidence rates of the sensitivities of Hepatitis B virus deoxyribonucleic acid(HBV DNA),Hepatitis C virus ribonucleic acid(HCV RNA)and Human immunodeficiency virus ribonucleic acid(1+2)(HIV 1+2 RNA)were respectively 100%,and percentages of the coefficient of variation(CV%)of the precision of them were respectively 1.57%,0.75%and 1.49%.When the system conducted nucleic acid test,the hemolytic plasma with a hemoglobin concentration level of 400mg/dl and the blood specimen with triglyceride concentration levels of 3 000 mg/dl did not affect the analysis performances of the standard substances of HBV-DNA(9.0 IU/ml),HCV-RNA(30.0 IU/ml)and HIV-RNA(135.0 IU/ml)of low concentration level.There were not cross-contaminations when 10 positive samples at high concentration(1 000 IU/ml)were cross-lined with 11 negative samples to conduct test.A total of 16(0.24%)reactive specimens were checked out from 6 703 specimens by Nucleic Acid Test(NAT)Technique under mixed mode.Conclusion:Nucleic acid test system must conduct performance verification before it is put into use,so as to ensure the safety of blood screening.The currently domestic nucleic acid test system can meet the requirements of screening blood safety.The performance verification of nucleic acid test system has great value in ensuring the safety of blood screening.
2.Assessment of bleeding risk for early anticoagulation after endoscopic cyanoacrylate injection in cirrhosis patients with gastric varices and portal vein thrombosis
Huishan WANG ; Ye FANG ; Sitao YE ; Xinghuan LI ; Xiaoquan HUANG ; Jian WANG ; Lili MA ; Shiyao CHEN
Chinese Journal of Clinical Medicine 2024;31(3):361-366
Objective To explore the effects of anticoagulation treatment to postoperative bleeding events in liver cirrhosis patients with gastric varices and portal vein thrombosis.Methods Patients diagnosed with portal vein thrombosis and treated with endoscopic cyanoacrylate injection at Zhongshan Hospital,Fudan University due to gastric variceal bleeding from January 2023 to December 2023 were included.Clinical data of patients were collected,and patients were divided into anticoagulant group and non-anticoagulant group based on whether anticoagulant treatment was performed within 48 h after treatment.Re-bleeding in patients was evaluated in 6 weeks of follow-up.Cox regression was used for univariate and multivariate analysis of re-bleeding within 6 weeks after treatment.Results A total of 160 patients were included,of whom 65 patients received anticoagulation treatment within 48 h after endoscopic cyanoacrylate injection.There were no statistically significant differences in gender,etiology of liver cirrhosis,dosage of cyanoacrylate and sclerosing agents,and Child-Pugh grading between the two groups.There was no statistically significant difference in re-bleeding rate within 6 weeks after treatment between the two groups(1.54%vs 1.05%,P=0.795).Multivariate Cox regression analysis showed that the large amount of cyanoacrylate was a risk factor for re-bleeding within 6 weeks after endoscopic treatment(HR=5.862,P=0.015).Conclusions For patients with liver cirrhosis,gastric varices,and portal vein thrombosis,who receive endoscopic cyanoacrylate injection,early anticoagulation does not increase the risk of re-bleeding after treatment,while a large amount of cyanoacrylate injection may be a risk factor for re-bleeding.However,sample should be increased to verify.
3.A multicenter study assessing the efficacy of various preoperative/pre-transfusion screening methods for blood transmitted disease
Junhua HU ; Li QIN ; Juan LIU ; Xinghuan MA ; Qin MENG ; Peng WANG ; Jiangcun YANG ; Rong GUI ; Chunhong DU ; Xiying LI ; Xianping LYU ; Rong XIA ; Fenghua LIU ; Shu SU ; Jinqi MA ; Yuan ZHANG ; Juan CAI ; Huifang JIN ; Qi ZHANG ; Jun ZHANG ; Rongyi CAO ; Bing HAN ; Jiwu GONG ; Jun ZHOU
Chinese Journal of Laboratory Medicine 2023;46(1):32-37
Objective:This multi-centre study was conducted to assess the efficacy of various preoperative/pre-transfusion screening methods for blood transmitted disease.Methods:From July 2021 to December 2021, plasma samples of patients admitted to 10 hospitals were collected for screening preoperative/pre-transfusion blood transmitted disease. Nucleic acid detection technology was used to detect hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA and human immunodeficiency virus (HIV)(1+2) RNA, and the results were compared with the immuno-serological methods. χ 2 test and Kappa test were used to analyze the efficacy of these two methods. Results:A total of 8 655 valid specimens were collected from 10 hospitals. There was a statistically significant difference in the positive detection rate of HCV between the two methods ( P<0.001). There was no significant difference in the positive detection rate of HBV and HIV assessed by the two methods ( P>0.05), but the number of positive cases detected by HBV DNA and HIV RNA (218 and 4 cases) was significantly higher than the corresponding serological results (216 and 2 cases). At the same time, there were HBV, HCV and HIV immuno-serological omissions by the immuno-serological methods, among which 28 cases were HBsAg negative and HBV DNA positive, 2 cases were HCV antibody negative and HCV RNA positive, and 2 cases were HIV antigen/antibody negative and HIV RNA positive. In addition, in the 66 samples with inconsistent results from the two detection methods, 83.3% (55/66), 68.2% (45/66), 63.6% (42/66) and 62.1% (41/66) of patients aged was>45 years, tumor, surgery and male, respectively. Conclusions:Compared with immuno-serological tests, nucleic acid tests have the advantage in terms of sensitivity on detecting HBV, HCV and HIV infection and could reduce missed detection. The risk of transmission can be reduced by adding HBV, HCV, and HIV nucleic acid tests to preoperative/pre-transfusion immuno-serological tests screening for patients over 45 years of age and tumor patients.
4.Changes in the bladder morphological structure and function and the expression significance of transforming growth factor-beta1 pathway-related proteins in neurogenic bladder rats
Yan CHEN ; Yuan MA ; Yulin HE ; Erpeng LIU ; Dong XING ; Xinghuan YANG ; Wen ZHU ; Qingwei WANG ; Qifeng DOU ; Huiqing ZHANG ; Jianguo WEN
Chinese Journal of Applied Clinical Pediatrics 2020;35(17):1336-1340
Objective:To investigate changes in the bladder morphological structure and function and the expression of transforming growth factor-beta1 (TGF-β1) pathway-related proteins in the bilateral spinal nerve amputated neurogenic bladder(NB) rat.Methods:A total of 64 female SD rats were included, and 32 of them underwent bilateral spinal nerve L6+ S1 amputation to construct the NB model and the others were used as sham operation controls.Rats in both NB and control groups received bladder cystometry 3, 6, 12, 24 weeks after corresponding operation.Collagen fibers in their bladder tissues were detected by Masson staining and Sirius scarlet staining.TGF-β1, Smad2 and Smad6 proteins were checked by immunohistochemical staining.TGF-β1 receptor Ⅰ protein was measured by Western blot.Results:Bladders in the NB group were instable, with bladder leak point pressure(BLPP) and underactive voiding pressures.The basal pressure [(22.10±2.51), (18.20±1.52), (31.20±2.82), (41.10±3.41) cmH 2O(1 cmH 2O=0.098 kPa)] and bladder volume [(22.30±1.72), (49.10±5.54), (30.30±2.68), (13.50±1.52) mL] of the NB rats at 3, 6, 12 and 24 weeks were significantly higher than those of the sham operation controls[(3.51±0.45) cmH 2O and (0.52±0.04) mL], and the difference were significant(all P<0.05). The bladder size and thickness in the NB group firstly increased (3, 6 weeks) and then decreased (12, 24 weeks), but the bladder weight increased continuously.Masson staining showed disordered fibrous connective tissues, disintegrated layered bla-dder wall, hypertrophied smooth muscle tissues and deposited intramuscular collagen on the nerve-amputated bladder wall.Sirius scarlet staining suggested that 24 weeks after nerve amputation, collagen Ⅲ increased greatly, and the ratio of type Ⅲ/Ⅰ collagen fibers (3.14±0.71) was significantly higher than that in the sham group (0.88±0.21) ( t= 7.48, P<0.01). According to the immunohistochemical staining results, the expressions of TGF-1β and Smad2 increased while the pathway inhibitory protein Smad6 decreased with time in the NB group.Western blot showed that the expression of TGF-β1 receptor Ⅰ in the amputated bladder was 1.3 and 1.6 folds higher than that in the sham group 12 weeks and 24 weeks after operation( t=6.06, 14.45, all P<0.01). Conclusions:In NB rats with bilateral spinal nerve amputated, bladder contraction becomes paralysis, intravesical pressure increases, bladder normal structure disintegrates and the fibrosis pathway TGF-β1/Smads is activated.Therefore, the key step of development of pediatric NB is bladder fibrosis, which should be prevented as early as possibly in the clinical practice.