Determination of slime-producing S. epidermidis specific antibodies in human immunoglobulin preparations and blood sera by an enzyme immunoassay

2000 ◽  
Vol 23 (2-3) ◽  
pp. 363-374 ◽  
Author(s):  
F Lamari ◽  
E.D Anastassiou ◽  
E Stamokosta ◽  
S Photopoulos ◽  
M Xanthou ◽  
...  
2019 ◽  
Vol 19 (2) ◽  
pp. 118-123
Author(s):  
O. G. Kornilova ◽  
E. A. Khusnatdinova ◽  
E. S. Konovalova ◽  
R. A. Volkova

The evaluation of anticomplementary activity, being an obligatory component of the quality control ofhuman immunoglobulin preparations, requires the use of a number of reagents of biological origin that are difficult to standardise. In order to standardise the quality control method used for determination of antiсomplementary activity it is advisable to use a reference standard which demonstrates whether obtained results comply with the acceptance criteria, and helps to assess the stability of analytical performance. The aim of the study was to assess the stability of analytical performance of the test procedure used for determination of antiсomplementary activity of human immunoglobulin preparations using human immunoglobulin reference standards of various grades. Materials and methods: anticomplementary activity was determined by the complement fixation test in accordance with the general monograph of the State Pharmacopoeia of the Russian Federation (14th ed.) OFS.1.8.2.0007.15 using different batches of guinea pig complement and sheep red blood cells. The test procedure was standardised using the OSO 42-28-430-2018 human immunoglobulin reference standard and the human immunoglobulin BRP, batch 1 (cat. No. Y0001504). The obtained results of anticomplementary activity of the reference standards were used to construct Shewhart control charts, using the certified values as control limits. Results: the analysis of the constructed Shewhart charts helped to assess trends, and estimate the influence of different batches of guinea pig complement and sheep red blood cells on the stability of analytical performance of the test procedure used for determination of antiсomplementary activity of human immunoglobulin preparations. Conclusions: the use of the OSO 42-28-430-2018 reference standard in combination with Shewhart control charts for the quality control of human immunoglobulin preparations in terms of Anticomplementary activity makes it possible to control the testing process, and assess any of its changes associated with the replacement of the batch of the reagent. At the same time, the reference standard of the European Pharmacopoeia, which has a wide range of permissible values, can only be used to confirm the acceptance of the results. Further studies to determine the mean value of the anticomplementary activity of control samples, as well as the standard deviation, may increase the possibilities of using this reference standard for assessment of analytical performance stability.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1083.2-1084
Author(s):  
O. Rusanova ◽  
A. Trofimenko ◽  
N. Emelyanov ◽  
O. Emelyanova

Background:Production of antibodies to ceruloplasmin (CP) in rheumatoid arthritis is an issue that has not been studied well enough. It was not by chance that this copper–containing alpha 2-glycorpoteid of blood plasma showing multienzymatic properties was chosen as an object of investigation. Data on the content and activity of CP in the blood of rheumatoid arthritis patients are contradictory, which has to do with different approaches to selection of patients and different measuring methods.Objectives:Improving diagnosis of rheumatoid arthritis by determination of antibodies to CP as well as its amount and enzymatic activity.Methods:We studied the serum from 30 apparently healthy individuals, and 108 rheumatoid arthritis patients. Antibodies to CP were determined by enzyme immunoassay using immobilized granulated antigen preparations (modification by Gontar et al, 2002). The amount of CP was determined by enzyme immunoassay according to the method of I.S. Kuzmina et al (1991) using commercial diagnostic agent manufactured by Mechnikov Research Institute for Vaccines and Sera.Results:Enzyme immunoassay showed a mean level of CP antibodies in donor sera of 0,020±0,006 optical density units. The level of normal values of specific antibodies determined as M±2σ included an extinction value in the range 0 – 0,086. The mean value of oxidase activity and the amount of CP in healthy people was 716±26,3 and 921±32 ng/ml, correspondingly. In the process of study we revealed a reliable increase in CP antibody count, the activity and amount of CP in patients with rheumatoid arthritis while in all cases the parameters under study correlated with the degree of disease activity (p<0,05): at activity degree I CP antibodies were 0,098±0,011; CP activity was 954±48,1; CP amount was 1292±73,4. At activity degree II CP antibodies were 0,138±0,007; CP activity was 1163±39,6; CP amount was 1763±69,3. At activity degree III, CP antibodies were 0,182±0,015; CP activity was 1368±89,5; CP amount was 1794±102,8. After a course of hospital treatment was completed, we noted a reliable decrease in the activity and amount of CP (at degree I of rheumatoid arthritis activity p<0,001, at degree II of rheumatoid arthritis activity p<0,01for both parameters; at degree III, p<0,05) compared with baseline findings. A decrease in CP antibodies shows decelerated dynamics, especially in patients with pronounced disease activity, which indicates severe disorders in the immunity that cannot be cured completely within 30 – 40 days of hospital treatment course.Conclusion:Determination of CP antibodies, as well as quantitative content of CP and its oxidase activity can serve as indicators of the activity of rheumatoid arthritis, as well as an accessory criterion of the effectiveness of administered therapy.Disclosure of Interests:None declared


1979 ◽  
Vol 91 (1) ◽  
pp. 158-166 ◽  
Author(s):  
Günter Emons ◽  
Peter Ball ◽  
Gertrud v. Postel ◽  
Rudolf Knuppen

ABSTRACT A bovine serum albumin conjugate of 2-methoxyoestrone was used for the preparation of highly specific antibodies in rabbits. Cross-reactivity for catecholoestrogens and monophenolic steroids was below 0.3 %. Only 2-methoxyoestradiol cross-reacted with 44 %. An assay procedure for the determination of unconjugated and conjugated 2-methoxyoestrone in human plasma is described. The following mean plasma concentrations (pg/ml) were found (unconjugated/conjugated): children 61/1130, young men 74/1320, elderly men 109/1260, cycling women 131/1040, post-menopausal women 102/1420, and pregnant women 3980/5850.


2010 ◽  
Vol 166 (1-2) ◽  
pp. 42-47 ◽  
Author(s):  
Thomas Scheper ◽  
Sandra Saschenbrecker ◽  
Katja Steinhagen ◽  
Andreas Sauerbrei ◽  
Waltraud Suer ◽  
...  

2021 ◽  
pp. 104063872110435
Author(s):  
Valeria Pasciu ◽  
Maria Nieddu ◽  
Elena Baralla ◽  
Cristian Porcu ◽  
Francesca Sotgiu ◽  
...  

Determination of serum or plasma progesterone (P4) concentrations is important to recognize pregnant and non-pregnant ewes, and also to predict the number of carried lambs. The 2 most common methodologies for the detection of plasma P4 are radioimmunoassay (RIA) and enzyme immunoassay (EIA). RIA is very expensive, and not all laboratories are equipped to perform this test; EIA is commercially available for human use, but only a few companies produce species-specific kits, which are expensive. We verified for ovine plasma a less expensive and easily available ELISA kit (DiaMetra) designed to quantify P4 in humans. Pools of ovine and human plasma were used to compare repeatability, accuracy, sensitivity, and stability of P4 measured by the DiaMetra kit. Repeatability data were within 15%, and accuracy values were ~90% for both plasma matrices. Stability data showed a loss of <20% for freeze–thaw and <30% for 30-d storage. All parameters were acceptable under international guidelines for method validation. The human ELISA kit was used successfully to quantify plasma P4 in 26 ewes during pregnancy until delivery. P4 concentrations were also correlated with the number of carried lambs.


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