scholarly journals TO010A NEW IMMUN-TOXICOLOGICAL TEST TO DETECT POLYSULFONE HYPERSENSITIVITY IN HEMODIALYSIS PATIENTS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Joachim Beige ◽  
Ralph Wendt ◽  
Despina Rüssmann ◽  
Karl-Peter Ringel
Keyword(s):  
False Negative ◽  
False Negative Rate ◽  
Lymphocyte Transformation ◽  
Clinical Problem ◽  
Lymphocyte Transformation Test ◽  
Laboratory Research ◽  
Humoral Immune ◽  
Before And After ◽  
Positive Results

Abstract Background and Aims Incompatibility of dialysis procedure due to hypersensitivity against dialyzer material which currently is mainly based on polysulfone and derivatives can not be assessed by routine laboratory tests. Although the frequency of such symptoms is suspected to be low (below 2%) such resembles an important clinical problem because dialysis procedures are frequently accompanied by symptoms of non-tolerability with reasons not being entirely clear while circulatory reasons are suspected to play a major role. Method To enlighten the role of polysulfone hypersensitivity, we adapted known standardized material immune-toxicological tests (lymphocyte transformation test, basophil degranulation test) to the specific conditions of dialysis and polysulfone material sensitivity. We developed a method of polysulfone micronisation and measured humoral immune response of isolated patient´s lymphocytes when incubated with polysulfone dispersion. Results 39 samples from 103 patients with suspected polysulfone hypersensitivity showed positive results for type 1 (n=19), type 4 (n=18) or both type (n=2) reactions. There were no significant differences in the level of stimulation measured for DI, SI and lymphogenesis before and after dialysis (average delta -0.4; -0.28; - 1.74, p = 0.71; 0.34; 0.37) and with different dialyzer materials (Tab. 1). Patients with pos. type 4 results (LTT and lymphogenesis) showed highly correlated results in either LTT or lymphogenesis test (Fig. 1, R=0.87, p<0.0001). 8 out of 8 samples from patients with repeated test on different PS showed positive results on either PS. One patient tested positive on PS showed no hypersensitivity with another non-PS (PMMA) material. Conclusion This is the first methodological report showing plausible in-vitro results of patients samples concerning polysulfone intolerance. On the first superficial view, a “false-negative” rate of 60% looks rather disappointing, because all samples derived from patients with suspicion of PS hypersensitivity. However, due to the clinical variability of intolerance symptoms and the high prevalence of any problems after HD initiation, mainly of circulatory origin after initiating extracorporeal circuit, this rate may obviously express the true frequency of isolated PS material hypersensitivity in suspected patients. Alternative pathophysiological pathways of material sensitivity like complement activation, remain to be elucidated and incorporated into a comprehensive future testing panel. Further clinical and laboratory research is needed to define true polysulfone hypersensitivity and to enlighten the field of hypothetic subclinical material incompatibility in patients with impaired dialysis tolerability.

A new immune-toxicological test for polysulfone hypersensitivity in hemodialysis patients

2020 ◽  
Vol 44 (1) ◽  
pp. 25-29
Author(s):  
Joachim Beige ◽  
Despina Rüssmann ◽  
Ralph Wendt ◽  
Karl-Peter Ringel
Keyword(s):  
Lymphocyte Transformation ◽  
Clinical Problem ◽  
Lymphocyte Transformation Test ◽  
Laboratory Research ◽  
Humoral Immune ◽  
Important Clinical Problem ◽  
Basophil Degranulation Test

Incompatibility of dialysis procedure due to hypersensitivity against dialyzer material, currently mainly based on polysulfone and derivatives, cannot be assessed by routine laboratory tests. Although the frequency of such symptoms is suspected to be lower than 2%, it resembles an important clinical problem because dialysis procedures are frequently accompanied by symptoms of non-tolerability with reasons not being entirely clear. To enlighten the role of polysulfone hypersensitivity, we adapted known standardized material immune-toxicological tests (lymphocyte transformation test, basophil degranulation test) to the specific conditions of dialysis and polysulfone material sensitivity. We developed a method of polysulfone micronisation and measured humoral immune response of isolated patient’s lymphocytes when incubated with polysulfone dispersion. Thirty-nine samples from 103 patients with suspected polysulfone hypersensitivity within the dialysis population of a nation-wide dialysis provider (n = 15.761 patients) showed positive results for type 1 (n = 19), type 4 (n = 18) or both type (n = 2) reactions. This is the first methodological report showing plausible in-vitro results of patients’ samples concerning polysulfone intolerance. Further clinical and laboratory research is needed to define true polysulfone hypersensitivity and to enlighten the field of hypothetic subclinical material incompatibility in patients with impaired dialysis tolerability.

Clinically Meaningful Change

Methodology ◽  
2019 ◽  
Vol 15 (3) ◽  
pp. 97-105
Author(s):  
Rodrigo Ferrer ◽  
Antonio Pardo
Keyword(s):  
Effect Size ◽  
False Negative ◽  
False Negative Rate ◽  
Point Of View ◽  
Skewed Distribution ◽  
Effect Sizes ◽  
False Negatives ◽  
Large Size ◽  
Before And After ◽  
Post Test

Abstract. In a recent paper, Ferrer and Pardo (2014) tested several distribution-based methods designed to assess when test scores obtained before and after an intervention reflect a statistically reliable change. However, we still do not know how these methods perform from the point of view of false negatives. For this purpose, we have simulated change scenarios (different effect sizes in a pre-post-test design) with distributions of different shapes and with different sample sizes. For each simulated scenario, we generated 1,000 samples. In each sample, we recorded the false-negative rate of the five distribution-based methods with the best performance from the point of view of the false positives. Our results have revealed unacceptable rates of false negatives even with effects of very large size, starting from 31.8% in an optimistic scenario (effect size of 2.0 and a normal distribution) to 99.9% in the worst scenario (effect size of 0.2 and a highly skewed distribution). Therefore, our results suggest that the widely used distribution-based methods must be applied with caution in a clinical context, because they need huge effect sizes to detect a true change. However, we made some considerations regarding the effect size and the cut-off points commonly used which allow us to be more precise in our estimates.

Diagnostic methods for confirming drug-allergy – the lymphocyte transformation test in dermatology

2008 ◽  
Vol 149 (24) ◽  
pp. 1107-1114
Author(s):  
Sarolta Makó ◽  
Réka Lepesi-Benkő ◽  
Márta Marschalkó ◽  
Gyöngyvér Soós ◽  
Sarolta Kárpáti
Keyword(s):  
Drug Allergy ◽  
Lymphocyte Transformation ◽  
Lymphocyte Transformation Test ◽  
Diagnostic Methods

A gyógyszermellékhatások felismerése és a tüneteket kiváltó gyógyszer oki szerepének bizonyítása komoly felkészültséget igényel. E közlemény célja a gyógyszerallergiás reakciók diagnosztikai lehetőségeinek rövid áttekintése és a lymphocytatranszformációs teszt gyógyszer-hiperszenzitivitási reakciókban való bizonyító szerepének bőrgyógyászati szempontok szerinti értékelése. A lymphocytatranszformációs teszt azon a megfigyelésen alapul, hogy a gyógyszerrel való első találkozáskor kialakult antigénspecifikus T-sejtek osztódni kezdenek az antigénnel való in vitro megismételt találkozás után. A szenzibilizációt az osztódó T-sejtekbe történő 3 H-timidin-beépülés mértéke jelzi. A hatóanyag-specifikus T-sejtek szinte mindig részt vesznek a gyógyszerallergiás reakciókban, ezért a vizsgálat előnye, hogy sok gyógyszernél és különböző immunreakciók eseteiben egyaránt jól alkalmazható. Hátránya a munkaigényesség, valamint az, hogy specificitásának és szenzitivitásának bizonyításához hiányoznak a széles körű, nagy beteganyagon elvégzett tanulmányok. Emiatt a teszt nem egyértelműen elfogadott a gyógyszerallergia igazolására. Hiányosságai ellenére azonban, jobb prediktív értékű egyéb vizsgálatok hiányában, a lymphocytatranszformációs tesztnek fontos szerepe van a gyógyszerallergiák diagnosztizálása terén.

Three Years of Experience With Random Urinary Homovanillic and Vanillylmandelic Acid Levels in the Diagnosis of Neuroblastoma

PEDIATRICS ◽  
1987 ◽  
Vol 79 (2) ◽  
pp. 203-205
Author(s):  
Mendel Tuchman ◽  
Margaret L. R. Ramnaraine ◽  
William G. Woods ◽  
William Krivit
Keyword(s):  
False Positive ◽  
Homovanillic Acid ◽  
False Negative ◽  
False Negative Rate ◽  
Urine Samples ◽  
Vanillylmandelic Acid ◽  
Test Results ◽  
Upper Limit ◽  
Positive Results ◽  
Rule Out

During the last 3 years, random urine samples from 408 patients were tested for elevated homovanillic acid (HVA) and vanillylmandelic acid (VMA) levels to rule out the diagnosis of neuroblastoma. Thirty-seven of these patients had elevated HVA and/or VMA levels, and neuroblastoma was subsequently diagnosed. In three additional patients with negative test results (normal HVA and VMA levels), tumors were subsequently diagnosed (false-negative rate of 7.5%). Ten percent of the patients with neuroblastoma had normal HVA and 27.5% had normal VMA levels at the time of diagnosis. Only one patient (2.5%) with neuroblastoma had elevated VMA levels in the presence of normal HVA levels. More than 60% of the patients with neuroblastoma had urinary HVA and/or VMA levels higher than twice the upper limit of normal. No false-positive results were encountered. Age and stage distributions of the patients are shown, and the significance of the results is discussed.

scholarly journals Herbal Medicine and False-Positive Results on Lymphocyte Transformation Test

2002 ◽  
Vol 122 (6) ◽  
pp. 399-402 ◽  
Author(s):  
Naoki MANTANI ◽  
Shinya SAKAI ◽  
Toshiaki KOGURE ◽  
Hirozo GOTO ◽  
Naotoshi SHIBAHARA ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
False Positive ◽  
Lymphocyte Transformation ◽  
Lymphocyte Transformation Test ◽  
Positive Results

scholarly journals Noninvasive preimplantation genetic testing for aneuploidy in spent medium may be more reliable than trophectoderm biopsy

2019 ◽  
Vol 116 (28) ◽  
pp. 14105-14112 ◽  
Author(s):  
Lei Huang ◽  
Berhan Bogale ◽  
Yaqiong Tang ◽  
Sijia Lu ◽  
Xiaoliang Sunney Xie ◽  
...  
Keyword(s):  
Genetic Testing ◽  
Inner Cell Mass ◽  
Culture Media ◽  
False Negative ◽  
Cell Mass ◽  
False Negative Rate ◽  
Critical Examination ◽  
Preimplantation Genetic Testing ◽  
Embryo Mosaicism

Preimplantation genetic testing for aneuploidy (PGT-A) with trophectoderm (TE) biopsy is widely applied in in vitro fertilization (IVF) to identify aneuploid embryos. However, potential safety concerns regarding biopsy and restrictions to only those embryos suitable for biopsy pose limitations. In addition, embryo mosaicism gives rise to false positives and false negatives in PGT-A because the inner cell mass (ICM) cells, which give rise to the fetus, are not tested. Here, we report a critical examination of the efficacy of noninvasive preimplantation genetic testing for aneuploidy (niPGT-A) in the spent culture media of human blastocysts by analyzing the cell-free DNA, which reflects ploidy of both the TE and ICM. Fifty-two frozen donated blastocysts with TE biopsy results were thawed; each of their spent culture medium was collected after 24-h culture and analyzed by next-generation sequencing (NGS). niPGT-A and TE-biopsy PGT-A results were compared with the sequencing results of the corresponding embryos, which were taken as true results for aneuploidy reporting. With removal of all corona-cumulus cells, the false-negative rate (FNR) for niPGT-A was found to be zero. By applying an appropriate threshold for mosaicism, both the positive predictive value (PPV) and specificity for niPGT-A were much higher than TE-biopsy PGT-A. Furthermore, the concordance rates for both embryo ploidy and chromosome copy numbers were higher for niPGT-A than TE-biopsy PGT-A. These results suggest that niPGT-A is less prone to errors associated with embryo mosaicism and is more reliable than TE-biopsy PGT-A.

scholarly journals Lymphocyte transformation test: The multiple positive results turned to all negative after influenza infection

2021 ◽  
Vol 9 (9) ◽  
Author(s):  
Makoto Kondo ◽  
Shohei Iida ◽  
Ai Umaoka ◽  
Takehisa Nakanishi ◽  
Yoshiaki Matsushima ◽  
...  
Keyword(s):  
Influenza Infection ◽  
Lymphocyte Transformation ◽  
Lymphocyte Transformation Test ◽  
Positive Results

scholarly journals Antibiotic hypersensitivity mimicking recurrent endocardits--identifying the culprit with the in vitro lymphocyte transformation test

QJM ◽  
2007 ◽  
Vol 101 (1) ◽  
pp. 67-68 ◽  
Author(s):  
H.L. Cooper ◽  
C. Pickard ◽  
E. Healy ◽  
P.S. Friedmann ◽  
P.W.X. Foley ◽  
...  
Keyword(s):  
Lymphocyte Transformation ◽  
Lymphocyte Transformation Test

scholarly journals Inactivated Poliovirus Vaccine Induces Antibodies that Inhibit RNA Synthesis of SARS-CoV-2: An open-label, pre-post vaccine clinical trial

2021 ◽  
Author(s):  
Brittany A. Comunale ◽  
Erin Jackson-Ward ◽  
Yong Jiang ◽  
Laura P. Ward ◽  
Qianna Liu ◽  
...  
Keyword(s):  
Immune Responses ◽  
Rna Synthesis ◽  
Post Inoculation ◽  
Open Label ◽  
Vaccination Rates ◽  
Humoral Immune ◽  
Positive Results ◽  
Practical Implications ◽  
Immune Response In Vitro

Background: Poliovirus vaccination induces an adaptive humoral immune response; in vitro experiments show polio-immune sera contain antibodies against the poliovirus RNA transcriptase that cross-react with SARS-CoV-2. While structural similarities between poliovirus and SARS-CoV-2 could have major implications for the COVID-19 response worldwide, polio-induced immune responses against SARS-CoV-2 have not been confirmed in prospective clinical trials. Objective: To evaluate whether immune sera from adults who recently received inactivated poliovirus vaccination (IPV) can block SARS-CoV-2′s ability to synthesize RNA. Intervention: IPV intramuscular injection. Measurements: Pre-inoculation and 4-weeks post-inoculation sera were tested for anti-3Dpol (RNA-dependent RNA polymerase, RdRp) antibodies using enzyme-linked immunosorbent assays (ELISA). To assess IPV′s ability to induce antibodies that inhibit SARS-CoV-2 RNA synthesis, immune-based detection assays tested RdRp enzymatic activity in polio-immune sera. Results: 298 of the 300 enrolled participants completed both on-site visits. Comparing pre-inoculation to 4-week samples, 85.2% of participants demonstrated an increase in anti-3Dpol antibodies against RdRp proteins. Among tested post-inoculation samples, 94.4% demonstrated inhibition of SARS-CoV-2 RNA synthesis. Few inoculation-related side effects were reported (2.0%), all were minor. Limitations: Participants were not systematically tested for COVID-19, though known exposures were reported and positive results (1.7%) were documented. Conclusion: IPV can induce antibodies that inhibit SARS-CoV-2 RNA synthesis, minimizing the risk of viral replication in infected individuals. This finding has practical implications for resource-deficient areas that may have limited access to newly developed COVID-19 vaccines and/or areas with low COVID-19 vaccination rates due to hesitancy. Funding Source: Private donors. Registration: ClinicalTrials.gov: NCT04639375.

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