Comparative evaluation of a new immunoradiometric assay for corticotropin

2006 ◽  
Vol 44 (5) ◽  
Author(s):  
Charles W. Wilkinson ◽  
Hershel Raff
Keyword(s):  
The United States ◽  
Cross Reactivity ◽  
Clinical Samples ◽  
Immunoradiometric Assay ◽  
Standard Curve ◽  
United States Food ◽  
In Vitro Diagnostic ◽  
States Food ◽  
Diagnostic Measurement

AbstractWe have characterized the performance of a commercial two-site immunoradiometric assay for manual in vitro diagnostic measurement of plasma corticotropin from Scantibodies Laboratory. We compared the results with those of a similar commonly used assay from Nichols Institute Diagnostics that has recently been withdrawn from production. The lower detection limit, range of the standard curve, cross-reactivity, and intra-assay and inter-assay imprecision of the two assays are very similar. Measurement of clinical samples and a series of samples from an experimental subject demonstrate high correlations between the two assays. These factors, together with recent clearance by the United States Food and Drug Administration for manual in vitro diagnostic measurement, make the Scantibodies corticotropin immunoradiometric assay an appropriate replacement for the Nichols assay.

scholarly journals In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends

Diagnostics ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. 202 ◽  
Author(s):  
Sandeep Kumar Vashist
Keyword(s):  
Point Of Care ◽  
The United States ◽  
Immunoglobulin M ◽  
Ongoing Research ◽  
Molecular Tests ◽  
Emerging Trends ◽  
Wide Range ◽  
United States Food ◽  
In Vitro Diagnostic

There have been tremendous advances in in vitro diagnostic (IVD) assays for coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main IVD assays used for COVID-19 employ real-time reverse transcriptase polymerase chain reaction (RT-PCR) that takes a few hours. But the assay duration has been shortened to 45 min by Cepheid. Of interest is the point-of-care (POC) molecular assay by Abbott that decreased the assay duration to just 5 min. Most molecular tests have been approved by the United States Food and Drug Administration (FDA) under emergency use authorization (EUA) and are Conformité Européenne (CE) marked. A wide range of serology immunoassays (IAs) have also been developed that complement the molecular assays for the diagnosis of COVID-19. The most prominent IAs are automated chemiluminescent IA (CLIA), manual ELISA, and rapid lateral flow IA (LFIA), which detect the immunoglobulin M (IgM) and immunoglobulin G (IgG) produced in persons in response to SARS-CoV-2 infection. The ongoing research efforts and advances in complementary technologies will pave the way to new POC IVD assays in the coming months. However, the performance of IVD assays needs to be critically evaluated before they are employed for the clinical diagnosis of COVID-19.

scholarly journals In Vitro Activities of Ceftobiprole and Doripenem Tested against Frequently Encountered Aerobic and Facultative Gram-Positive and Gram-Negative Bacterial Pathogens Isolated from Patients in Canadian Hospitals in 2007

2009 ◽  
Vol 20 (suppl a) ◽  
pp. 59A-66A
Author(s):  
James A Karlowsky ◽  
Mel DeCorby ◽  
Daryl J Hoban ◽  
George G Zhanel
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Methicillin Resistant ◽  
E Coli ◽  
United States Food ◽  
States Food ◽  
Health Canada

BACKGROUND: In 2008, ceftobiprole was approved by Health Canada for the treatment of patients with complicated skin and skin structure infections including diabetic foot infections; approval of ceftobiprole by the United States Food and Drug Administration is pending. Doripenem is currently under review by Health Canada and was approved by the United States Food and Drug Administration in 2007 for the treatment of patients with complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis. OBJECTIVES: To determine the in vitro activities of ceftobiprole and doripenem using a collection of frequently isolated aerobic and facultative bacteria cultured from patient blood, urine, respiratory and wound specimens in 12 Canadian hospitals in 2007. MEtHODS: Isolates were tested for their susceptibility to a panel of antimicrobial agents using the Clinical and Laboratory Standards Institute broth microdilution method. RESULTS: Ceftobiprole inhibited all isolates of methicillin-resistantStaphylococcus aureus(n=385), methicillin-resistantStaphylococcus epidermidis(n=20), methicillin-susceptibleS aureus(n=1095) and methicillin-susceptibleS epidermidis(n=108) at a minimum inhibitory concentration (MIC) of 2 μg/mL or less; all isolates ofStreptococcus pyogenes(n=105) were inhibited by ceftobiprole at 0.06 μg/mL or less. All isolates ofS aureus(MIC 4 μg/mL or less) andS pyogenes(MIC 0.5 μg/mL or less) tested were susceptible to ceftobiprole. Greater than 99% of extended-spectrum beta-lactamase (ESBL)-negativeEscherichia coli(n=1528) andKlebsiella pneumoniae(n=436) were susceptible to ceftobiprole (MIC 1 μg/mL or less); against other genera/species of Enterobacteriaceae, susceptibility to ceftobiprole ranged from 80.7% forEnterobacter cloacae(n=166) to 99.2% forProteus mirabilis(n=119). Ceftobiprole was less active againstPseudomonas aeruginosa(n=633) (90% of isolates inhibited at a concentration of 32 μg/mL [MIC90]) than Enterobacteriaceae. Doripenem inhibited 90% of isolates ofE coli(n=1577) andK pneumoniae(n=456), including ESBL-producing isolates (n=69), and E cloacae at a concentration of 0.06 μg/mL or less; doripenem and meropenem had MIC90s of 8 μg/mL for the isolates ofP aeruginosatested. Doripenem demonstrated in vitro activity indistinguishable from that of meropenem against Gram-positive pathogens. CONCLUSIONS: All isolates of methicillin-resistantS aureustested were susceptible to ceftobiprole (MIC 4 μg/mL or less), differentiating it from any other currently marketed beta-lactam. Doripenem demonstrated potent activity (MIC900.5 μg/mL or less) against all isolates of Enterobacteriaceae tested, including ESBL-producingE coliandK pneumoniae, and as potent activity as meropenem (MIC908 μg/mL) againstP aeruginosa. The current study demonstrated both ceftobiprole and doripenem to be promising broad-spectrum antibacterial agents.

In Vitro Diagnostics for COVID-19: State-of-the-Art, Future Directions and Role in Pandemic Response

2021 ◽  
Author(s):  
Sandeep Kumar Vashist ◽  
Subramanian Murugan ◽  
Guiffo Djoko
Keyword(s):  
Point Of Care ◽  
Immunoglobulin A ◽  
The United States ◽  
Immunoglobulin M ◽  
In Vitro Diagnostics ◽  
Rt Pcr ◽  
United States Food ◽  
States Food ◽  
Almost All

There have been tremendous advances in in vitro diagnostics (IVD) for coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although the confirmatory clinical diagnosis is made by real-time reverse transcriptase polymerase chain reaction (RT-PCR), lateral flow immunoassay (LFIA) based viral antigen (Ag) detection is used for mass population screening at point-of-care (POC) settings. The rapid RT-PCR tests (such as from Cepheid and Bosch) have an assay duration of less than 40 min, while most rapid Ag tests (such as Abbott’s BinaxNOW™ COVID-19 Ag card) have an assay duration of about 15 min. Of interest is the POC molecular test (ID NOW™) from Abbott that takes less than13 min. Similarly, many immunoassays (IAs), i.e., automated chemiluminescent IA (CLIA), manual ELISA, and LFIA, have been developed to detect immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) produced in subjects after SARS-CoV-2 infection. Many IVD tests have been approved by the United States Food and Drug Administration (FDA) under emergency use authorization (EUA), and almost all IVD tests are Conformité Européenne (CE) certified.

scholarly journals Analysis of Potential β-Lactam Surrogates To Predict In Vitro Susceptibility and Resistance to Ceftaroline for Clinical Isolates of Enterobacteriaceae

2018 ◽  
Vol 56 (4) ◽  
pp. e01892-17
Author(s):  
Meredith A. Hackel ◽  
Joseph P. Iaconis ◽  
James A. Karlowsky ◽  
Daniel F. Sahm
Keyword(s):  
Antimicrobial Susceptibility ◽  
Susceptibility Testing ◽  
The United States ◽  
Antimicrobial Susceptibility Testing ◽  
Clinical Isolates ◽  
Content Type ◽  
United States Food ◽  
States Food ◽  
Susceptibility And Resistance

ABSTRACT Ceftaroline fosamil was approved by the United States Food and Drug Administration in 2010 and by the European Medicines Agency in 2012. As of April 2017, only one commercial antimicrobial susceptibility testing device offered a Gram-negative panel that included ceftaroline. This circumstance is unfortunate, as many clinical microbiology laboratories rely solely on commercial devices to generate in vitro antimicrobial susceptibility testing results for common bacterial pathogens. In lieu of device-based testing of clinical isolates of Enterobacteriaceae, laboratories wishing to test ceftaroline must either opt for disk diffusion testing or use a gradient strip; however, both alternatives interrupt laboratory workflow and require additional labor and expense. Identification of a reliable surrogate β-lactam to predict in vitro susceptibility to ceftaroline may offer another interim solution as laboratories await availability of ceftaroline for testing on their commercial devices. We tested six β-lactams (aztreonam, ceftazidime, ceftriaxone, cefotaxime, cefoxitin, and cefpodoxime) as potential surrogates for ceftaroline against a collection of 543 clinical isolates of Enterobacteriaceae selected to approximate the distribution of ceftaroline MICs observed in AWARE global surveillance studies conducted in 2013. All six potential surrogates generated very major error rates of 16.3% to 56.6%, far exceeding the accepted limit of 1.5% set by the Clinical and Laboratory Standards Institute (CLSI) and the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health. Failure to identify a reliable surrogate to predict in vitro susceptibility and resistance to ceftaroline for clinical isolates of Enterobacteriaceae underscores the need for expedited addition of newer antimicrobial agents to commercial antimicrobial susceptibility testing devices.

Delirium Secondary to Lamotrigine Toxicity

2020 ◽  
Vol 15 (2) ◽  
pp. 156-159 ◽  
Author(s):  
Deborah L. Sanchez ◽  
Adam J. Fusick ◽  
Steven R. Gunther ◽  
Michael J. Hernandez ◽  
Gregory A. Sullivan ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Valproic Acid ◽  
Mental Status ◽  
The United States ◽  
Clinical Correlation ◽  
Medication Regimen ◽  
Medication Effects ◽  
United States Food ◽  
States Food ◽  
Rule Out

Background: Lamotrigine is a phenyltriazine medication that has been approved by the United States Food and Drug Administration as monotherapy and as an adjunctive agent for the treatment of seizure disorder. It was later approved by the FDA for the treatment of bipolar disorder. Lamotrigine is generally well tolerated by patients, but some serious symptoms can occur during treatment. These severe side effects include rashes and multi-organ failure. Lamotrigine has also been associated with the development of mental status changes, frequently when used concurrently with other medications that may impact the metabolism of lamotrigine. Objective: To present the case of a 65-year-old man being treated with lamotrigine and valproic acid who developed mental status changes after the addition of sertraline to his medication regimen, and to compare this case to existing cases reported in the literature. Discussion: Our case adds to the existing literature by demonstrating that patients may experience adverse medication effects despite lamotrigine levels that are normally considered to be in the therapeutic range, highlighting the importance of clinical correlation when obtaining medication levels. Conclusion: Clinicians should use caution interpreting lamotrigine levels when working up delirium, as normal levels may not rule out the development of lamotrigine toxicity.

scholarly journals The Efficacy of Convalescent Plasma Use in Critically Ill COVID-19 Patients

Medicina ◽  
2021 ◽  
Vol 57 (3) ◽  
pp. 257
Author(s):  
Livius Tirnea ◽  
Felix Bratosin ◽  
Iulia Vidican ◽  
Bianca Cerbu ◽  
Mirela Turaiche ◽  
...  
Keyword(s):  
Pilot Study ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Therapeutic Option ◽  
White Blood Cells ◽  
The United States ◽  
Plasma Therapy ◽  
Reactive Protein ◽  
United States Food ◽  
States Food

Background and Objectives: On 24 March 2020, the United States Food and Drug Administration (FDA) announced the approval of convalescent plasma therapy for critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as an emergency investigational new drug. This pilot study from Romania aimed to determine if convalescent plasma transfusion can be beneficial in the treatment of selected critically ill patients diagnosed with a SARS-CoV-2 infection. Materials and Methods: Donor and receiver eligibility for critically ill coronavirus disease 2019 (COVID-19) patients was based on Romanian guidelines issued at the time of the study. Here, we describe the evolution of a total of five eligible patients diagnosed with COVID-19 who received convalescent plasma (CP) in Romania. Results: In spite of our efforts and convalescent plasma administration, three of the five patients did not survive, while the other two recovered completely. Over the course of our five-day laboratory record, the surviving patients had significantly lower values for C-reactive protein, interleukin-6, and white blood cells. Conclusions: This pilot study provides insufficient evidence to determine the efficacy of convalescent plasma use as a therapeutic option for critically ill COVID-19 patients.

scholarly journals Review of COVID-19 mRNA Vaccines: BNT162b2 and mRNA-1273

2021 ◽  
pp. 089719002110096
Author(s):  
Shyh Poh Teo
Keyword(s):  
Vaccine Development ◽  
Safety Data ◽  
The United States ◽  
Virus Infections ◽  
Phase 3 ◽  
Vaccination Programs ◽  
Safety Surveillance ◽  
Mass Immunization ◽  
United States Food ◽  
States Food

The United States Food and Drug Administration recently issued emergency use authorization for 2 mRNA vaccines for preventing COVID-19 disease caused by SARS-CoV-2 virus infections. BNT162b2 from Pfizer-BioNTech and mRNA-1273 by Moderna are planned for use in mass-immunization programs to curb the pandemic. A brief overview of COVID-19 mRNA vaccines is provided, describing the SARS-CoV-2 RNA, how mRNA vaccines work and the advantages of mRNA over other vaccine platforms. The Pfizer-BioNTech collaboration journey to short-list mRNA vaccine candidates and finally selecting BNT162b2 based on safety data is outlined, followed by the Phase 3 study of BNT162b2 demonstrating 95% efficacy in preventing COVID-19 infections. Studies regarding mRNA-1273 (Moderna) are described, including extended immunogenicity data up to 119 days. The Phase 3 COVE study of mRNA-1273 eventually showed vaccine efficacy of 94.5%. Recommendations for future mRNA vaccine development are provided, including ongoing safety surveillance, evaluation in under-represented groups in previous studies and improving mRNA vaccine thermostability. Finally, further logistical considerations are required for manufacturing, storing, distribution and implementing mass vaccination programs to curb the pandemic.

scholarly journals Botulinum toxin in the management of chronic migraine: clinical evidence and experience

2016 ◽  
Vol 10 (2) ◽  
pp. 127-135 ◽  
Author(s):  
Claus M Escher ◽  
Lejla Paracka ◽  
Dirk Dressler ◽  
Katja Kollewe
Keyword(s):  
Chronic Migraine ◽  
Botulinum Neurotoxin ◽  
Prophylactic Treatment ◽  
Clinical Evidence ◽  
The United States ◽  
Headache Frequency ◽  
United States Food ◽  
History Of ◽  
States Food ◽  
Review Reports

Chronic migraine (CM) is a severely disabling neurological condition characterized by episodes of pulsating unilateral or bilateral headache. The United States Food and Drug Administration (FDA) approved onabotulinumtoxinA (Botox®) for the prophylactic treatment of CM in 2010. It has been shown that onabotulinumtoxinA is effective in the reduction of headache frequency and severity in patients with CM. Treatment is well tolerated by the patients. This review reports on the history of botulinum neurotoxin (BoNT) in CM and presents the current clinical evidence for the use of onabotulinumtoxinA in the treatment of CM.

scholarly journals Clinical Development of Biological Response Modifiers

1994 ◽  
Vol 5 (suppl a) ◽  
pp. 5A-8A
Author(s):  
Jay P Siegel
Keyword(s):  
Adverse Reactions ◽  
Biological Response ◽  
Clinical Trial Design ◽  
The United States ◽  
Biological Response Modifier ◽  
Clinical Development ◽  
Response Modifier ◽  
United States Food ◽  
Study Population ◽  
States Food

OBJECTIVE: To present perspectives on selected issues that frequently arise during the clinical development of biological response modifier (BRM) therapies.DATA SOURCES: The perspectives and opinions presented herein were developed over several years of reviewing and consulting on the clinical development of BRM therapies at the United States Food and Drug Administration.CONCLUSIONS: BRM therapies encompass a broad spectrum of products used to treat a wide variety of diseases. Due to this diversity. most principles of clinical trial design and conduct applicable to the majority of BRMS are those that are applicable to all therapies. Nevertheless, the clinical development of BRM therapies often raises specific issues and problems in the areas of selecting animal models, defining the study population, adverse reactions, dosing and defining end-points. Over 10 years’ experience in testing biotechnology derived BRMS in clinical trials has created a database from which we can draw valuable generalizations for guidance in future studies.

Safety assessment of natural products in Malaysia: current practices, challenges, and new strategies

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Nur Azra M. Pauzi ◽  
Manraj S. Cheema ◽  
Amin Ismail ◽  
Ahmad Rohi Ghazali ◽  
Rozaini Abdullah
Keyword(s):  
Natural Products ◽  
Animal Studies ◽  
Regulatory System ◽  
The United States ◽  
Regulatory Control ◽  
Health Maintenance ◽  
Traditional Medicines ◽  
Aristolochic Acids ◽  
United States Food ◽  
States Food

Abstract The belief that natural products are inherently safe is a primary reason for consumers to choose traditional medicines and herbal supplements for health maintenance and disease prevention. Unfortunately, some natural products on the market have been found to contain toxic compounds, such as heavy metals and microbes, as well as banned ingredients such as aristolochic acids. It shows that the existing regulatory system is inadequate and highlights the importance of thorough safety evaluations. In Malaysia, the National Pharmaceutical Regulatory Agency is responsible for the regulatory control of medicinal products and cosmetics, including natural products. For registration purpose, the safety of natural products is primarily determined through the review of documents, including monographs, research articles and scientific reports. One of the main factors hampering safety evaluations of natural products is the lack of toxicological data from animal studies. However, international regulatory agencies such as the European Food Safety Authority and the United States Food and Drug Administration are beginning to accept data obtained using alternative strategies such as non-animal predictive toxicological tools. Our paper discusses the use of state-of-the-art techniques, including chemometrics, in silico modelling and omics technologies and their applications to the safety assessments of natural products.

Sign in / Sign up

Export Citation Format

Share Document