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Objective To evaluate the limit of detection of eight enzyme-linked immunosorbent assay (ELISA) according to hospital grade assessment and ISO15189:2012.Methods According to the new health industry standard WS/T 514-2017:"Establishment and verification of detection capability for clinical laboratory measurement procedures",the limit of detection (LoD) was established,in the sameset of detection system,using two reagent lot,each lot for 5 consecutive days 4 consecutive days to assess the value of the concentration of five specimens were detected repeatedly,calculated the corresponding hit rate,then transform into probability units,and the corresponding concentration value production regression model,the hit rate of 95 ％ corresponds to the probability unit 1.645 substituted into the equation,the resulting concentration value was LoD estimates.The detection limit values were tested for 3 consecutive days of detection of two LoD concentrations near the declared concentration of the sample (diluted by the standard material) was detected 4 times repeatedly to calculate the positive result was greater than or equal to the percentage of LoD statement,greater than or equal to the critical value of 87％,then verified success.Results HBsAg:0.100 IU/ml,HBsAb:9.642 mIU/ml,HBeAg:0.666 NCU/ml,HBeAb:3.700 NCU/ml,HBcAb:0.786 IU /ml,HCV:0.506 NCU/ml,TP:2.236 mIU/ml and HIV:0.135 NCU/ml.The detection limit estimates were passed.Conclusion The verification limit of the verification project in the testing method and detection system of the laboratory meet the requirements Objective.
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Objective To analyze the effect of bifrontal decompressive craniectomy on patients with refractory diffusing of brain swelling after severe traumatic brain injury.Methods The clinical data of 68 patients with refractory diffusing of brain swelling after severe traumatic brain injury were analyzed retrospectively.Thirty-five patients were performed with bifrontal decompressive craniectomy as observed group,continued intracranial pressure monitoring after surgery.Thirty-three patients were treated conservatively to reduce intracranial pressure as control group,continued intracranial pressure monitoring.The Glasgow outcome scale after discharge 6 months were assessed.The efficacy,the incidence of complications were observed in observed group.Results The admission intracranial pressure in observed group was significantly higher than that after surgery [(35.9 ±6.9) mmHg (1 mmHg =0.133 kPa) vs.(17.5 ±5.2) mmHg,P ＜0.05].The admission intracranial pressure in control group was (34.2 ± 8.6) mmHg,after admission 10.5 h was (32.0 ±4.8) mmHg (P ＜0.05),difference was no statistically significant (P＞ 0.05).The intracranial pressure after admission 10.5 h in control group was significantly higher than that in observed group after surgery (P ＜0.05).Two cases of subdural effusion,1 case of postoperative hydrocephalus in observed group.The better prognosis rate in observed group was significantly higher than that in control group [45.7％ (16/35) vs.18.2％ (6/33),P ＜ 0.05].Conclusions Bifrontal decompressive craniectomy is a suitable measure to decrease the intracranial pressure in the patients with refractory diffusing of brain swelling.If carried out early,it could provide better outcome for these patients.
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OBJECTIVE: To summarize the classification, property of skull repair material and the processing of related complications in the application of repairing and remodeling the skull.METHODS: The PubMed database (http://www.ncbi.nlm.nih.gov/PubMed) and CNKI Database (www.cnki.net/index.htm) was searched by the first author using key words of "codubix, synmesh, and bone cement" both in English and Chinese. Articles whose content is related to the types, property, biocompatibility and its application effect of skull repairing materials were selected. In the same field, the articles published by authoritative journals or different races were preferred. The repetitive or obsolete literatures were excluded. After that 26 documents were included in this paper.RESULTS: The bone cement exhibited good histocompatibility, however, it is difficult to be absorbed, thus, it only be used for repairing part of skull defects. The study found that titanium had good biocompatibility and could combine with the skull. Its application had a promising prospect, but there are many inadequacies. With the continuous deepening of bio-engineering, bone tissue engineering, and cartilage tissue engineering, it will provide a broader perspective for the study of skull repair materials.CONCLUSION: There are many kinds of materials for skull repairing, and this paper only introduces some of the widely used ones. Actually, the selection of repairing materials should consider the pathogenetic condition, economic condition, local equipment and technical levels. If possible, titanium mesh and titanium screw are preferred, which is characterized by easy operation, few complication and beautiful appearance: When using autogenous bone or bone cements, if related complications can be reduced and handled effectively, the results will be satisfactory.