摘要
Objective To explore the application and safety of apheresis technology in collection of Coronavirus Disease 2019 (COVID-19) convalescent plasma (CP), and to analyze the quality characteristics of the plasma. Methods The general data of COVID-19 convalescent plasma (CP) donors, including gender, age, date of discharge or release from medical isolation, were collected based on informed consent. After physical examination, the CP was collected by apheresis technology with plasma separator, inactivated with methylene blue, and determined for severe acute respiratory symptom Coronavirus 2 (SARS-CoV-2) nucleic acid and specific antibody (RBD-IgG) against SARS-CoV-2. Results The collection process went well, and no serious adverse events related to plasma collection were reported during or after the collection. The average age of COVID-19 CP donors was 38 years (n = 933). The distributions of blood groups A, B, AB and 0 in RhD (+) COVID-19 CP were 33. 4%, 29. 2%, 10% and 27. 2% respectively. The plasma donation date was 18 d from the discharge date in average. All the test results of SARS-CoV-2 nucleic acid in CP were negative, while the proportion of plasma samples at SARS-CoV-2 antibody titer of more than 1: 160 was 92. 60%. Conclusion Apheresis technology was safe and reliable. The COVID-19 CP contained high titer antibody. Large-scale collection and preparation of inactivated plasma against SARS-CoV-2 played an important role in the treatment of COVID-19.
摘要
OBJECTIVE: This study aimed to determine the relative and independent contributions of impaired metabolic health and obesity to coronavirus disease 2019 (COVID-19) outcomes. METHODS: We analyzed 4,069 COVID-19 patients between January and June 2020 in South Korea, classified into four groups according to metabolic health status and body mass index (BMI): metabolically healthy normal weight (MHNW), metabolically unhealthy normal weight (MUNW), metabolically healthy obese (MHO), and metabolically unhealthy obese (MUO). The primary outcome was a composite of intensive care unit (ICU) admission, invasive mechanical ventilation (IMV), extracorporeal membrane oxygenation (ECMO), and death. Multivariable Cox proportional hazard regression models were used to estimate the hazard ratio (HR) for the outcome. RESULTS: The incidence rate (per 100 person-months) of severe COVID-19 outcomes was the lowest in the MHNW group (0.90), followed by the MHO (1.64), MUNW (3.37), and MUO (3.37) groups. Compared with MHNW, a significantly increased risk of severe COVID-19 was observed in MUNW (HR, 1.41;95% CI, 1.01-1.98) and MUO (HR, 1.77;95% CI, 1.39-2.44) but not in MHO (HR, 1.48;95% CI, 0.98-2.23). The risk of ICU admission or IMV/ECMO was increased only in MUO;however, the risk of death was significantly higher in MUNW and MUO. The risk of severe COVID-19 increased insignificantly by 2% per 1 kg/m2 BMI increase but significantly by 13% per 1 metabolically unhealthy component increase, even after mutually adjusting for BMI and metabolic health status. CONCLUSION: Metabolic health is more important to COVID-19 outcomes than obesity.
摘要
Objective: To systematically analyze the 670 convalescent plasma (CP) samples from patients with coro-navirus disease 2019 (COVID-19). Methods: The plasma samples were analyzed and evaluated for routine test items including hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV)-l/HI V-2 antibody, Treponema pallidum (TP) and alanine aminotransferase (ALT) as well as blood group, nucleic acid of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), IgG antibody, methylene blue residue and sterility. Results: A total of 121 substandard plasma samples were detected from 670 convalescent plasma samples, of which substandard IgG antibody titer accounted for the highest proportion of 7. 91%. In the turn of proportions, the blood groups were A (32. 52%), B (29. 94%), 0 (28. 886%) and AB (8. 66%). Ml the test results of nucleic acids of SARS-CoV-2 were negative. A total of 485 samples were from Wuhan, of which the highest proportion (21. 95%) were from the donors at ages of > 30 ∼ 35 years, including 264 males and 221 females. Of the high titer plasma, those at titers of not less than 1: 640 accounted for the highest proportion (77. 43%). Most of the IgG titers in plasma of common patients were not less than 1: 640 > 10 - 20 d, while were less than 1: 160 3 ∼ 10 d, after hospitalization. However, 35 plasma samples were negative for IgG antibody (at titers of less than 1: 80), in 9 of which other pathogens were detected. Conclusion: Unqualified IgG titer was the main reason for unqualified CP. The proportion of CP of group O was lower than that of the group in healthy population. The highest proportion of plasma donors in Wuhan was in the populations at ages of > 30 ∼ 35 years, which was higher in males than in females. Satisfactory immune responses were induced in most of patients in convalescence period, which removed the virus in vivo effectively. High antibody titers were induced > 10 ~ 20 d after hospitalization, making the common cases were not easy to change into severe ones. It was speculated that patients negative for IgG antibody might be infected with other pathogens. © 2020 Changchun Institute of Biological Products. All rights reserved.
摘要
Objective: To establish a detection method for the methylene blue residues in inactivated plasma against SARS-CoV-2, and to apply the method to inactivated plasma of different dosages. Methods: Methylene blue in plasma was absorbed using solid phase extraction cartridge, and the absorbance at 654 nm was measured by UV-2550 spectrophotometer. The absorbance of the eluate extract from standard control plasma and virus inactivated plasma by solid phase was measured, and the methylene blue residue in the test plasma was calculated based on the ratio of the absorbance. Then, linearity-range, precision, accuracy and quantitative limit of the method are validated based on 11 batches of inactivated plasma in specifications of 50, 75 and 100 mL. Results: The detection method of methylene blue residue, was established within the linear range of 0.01~0.05 μmol•L-1. The verification standards are as follows: R value is 0.994 4;precision is 7% and accuracy is between 102%~110%;and the quantitative limit is 0.013 μmol•L-1;the quantitative detection CV is less than 5%, all of which are in conformity with requirements of Pharmacopoeia of PRC (Edition 2015). The levels of methylene blue residue in inactivated plasma of each specification were within the detection range of the developed method, and the residue levels were much lower than that in standard(≤0.30 μmol•L-1). Conclusion: The method can be successfully applied for the detection of methylene blue residues in the inactivated plasma against SARS-COV-2 of different specifications.