Endotoxin Testing

Vanhaecke, E.; Pijck, J.; Vuye, A.

doi:10.1111/j.1365-2710.1987.tb00531.x

Cited by 14 publications

(4 citation statements)

References 43 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…1 Various structural components of bacteria, yeasts, and molds have been isolated and characterized as pyrogenic. 2 Organic and inorganic dusts, nanoparticles, and diesel exhaust particles may also induce an inflammatory reaction, although the nature of their pyrogenic components is not yet known.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

In vitro pyrogen test—A new test method for solid medical devices

Mazzotti

Beuttler

Zeller

et al. 2006

J Biomedical Materials Res

View full text Add to dashboard Cite

Medical devices manufactured for implantation into humans must be free of any contamination with viable bacteria. However, remnants of dead bacteria and bacterial components alone may induce an inflammatory immune response. Pyrogen tests for such inflammatory contaminations are generally performed either by determining the content of lipopolysaccharide in rinsing solutions of batch samples by limulus amoebocyte lysate assay, by injecting the rinsing solutions into rabbits or by implanting batch samples into rabbits and measuring change of body temperature. In this study, we show that the in vitro pyrogen test (IPT), which measures the release of the inflammatory cytokine IL-1beta in fresh or cryopreserved human whole blood, can be used to assess the pyrogenic contamination of implantable medical devices. This test was used to check neurosurgical implants, namely aneurysm clips, as a proof of principle. Owing to the direct contact of the test material with the blood cells, this test does not require rinsing procedures, which have variable efficacy. The use of human blood ensures the detection of all substances that are pyrogenic for humans and reflects their relative potency. The safety of the products as delivered could be confirmed. The effects of sterilization and depyrogenization procedures on intentional pyrogenic contaminations of samples could be followed. This new application of the already internationally validated method promises to replace further rabbit pyrogen tests. It generates extremely sensitive results with an extended range of detectable pyrogenic contaminants.

show abstract

Section: Introductionmentioning

confidence: 99%

“…11 The assay can only be performed with liquid samples, thus again only a rinsing solution of the biomaterial can be assessed. 1 The rinsing solution is prepared with purified water, with or without a detergent (Tween 20). By detecting LPS, the LAL detects the most common and most potent pyrogen known with high sensitivity.…”

Section: Introductionmentioning

confidence: 99%

In vitro pyrogen test—A new test method for solid medical devices

Mazzotti

Beuttler

Zeller

et al. 2006

J Biomedical Materials Res

View full text Add to dashboard Cite

show abstract

“…The common Limulus amoebocyte lysate (LAL)-based methods of endotoxin testing are not applicable to endotoxin determination in HBOCs, unless the assay is modified to account for the presence of endotoxin-binding hemoglobin [94][95][96]. Chromogenic method of endotoxin testing is based on the generation of free p-nitroaniline (pNA) by cleavage action of procoagulant enzymes of LAL on a peptide-pNA conjugate and spectrophotometry at 405 nm.…”

Section: Endotoxinmentioning

confidence: 99%

Pharmaceutical Aspects of Hemoglobin-Based Oxygen Carriers

Awasthi¹

2005

CDD

View full text Add to dashboard Cite

Oxygen delivery has evolved as a therapy of widespread interest in the clinical setting, especially in emergency medicine and anesthesiology. With the widespread recognition of blood-borne infections during the last two decades and the looming shortage of donor blood in future, efforts to formulate an artificial substitute for oxygen carrying capacity of RBCs have increased. Such blood substitutes, defined more correctly as oxygen therapeutics, are particularly valuable in circumstances such as war and trauma situations where properly matched blood may not be immediately available or is not accepted by the recipients for religious reasons. Several elegant formulations of hemoglobin, both free and encapsulated, have evolved recently and are collectively referred to as hemoglobin-based oxygen carriers (HBOCs). Few HBOCs have successfully entered into the clinical phase. This review discusses formulation requirements of HBOCs from a physiological viewpoint. Physico-pharmaceutical parameters, such as colloidal oncotic pressure, osmolality, viscosity, sterility, apyrogenicity and shelf-stability are traditionally a concern for large volume parenterals meant for resuscitation purposes. At the same time, properties such as oxygen affinity, hemoglobin content and in vivo efficacy of oxygen carriers are specific to HBOCs. Owing to the presence of a very active and functional protein (hemoglobin), requirements for adequate performance of HBOCs significantly differ from those of other large-volume parenterals, such as lactated Ringer's solution, and plasma expanders, such as dextran or albumin solutions.

show abstract

“…The scheme for on-site preparation of Tc-99m HSA for clinical application. (Vanhaecke et al 1987). The sensitivity of the LAL reagent is 0.25 endotoxin units (EU)/ml.…”

Section: Pyrogenicity and Sterility Testingmentioning

confidence: 99%

On-Site Preparation of Technetium-99m Labeled Human Serum Albumin for Clinical Application

Wang

Chuang

Chiu

et al. 2007

Tohoku J. Exp. Med.

View full text Add to dashboard Cite

Technetium-99m labeled human serum albumin (Tc-99m HSA) is an important radiopharmaceutical for clinical applications, such as cardiac function tests or protein-losing gastroenteropathy assessment. However, because of transfusion-induced infectious diseases, the safety of serum products is a serious concern. In this context, serum products acquired from patients themselves are the most ideal tracer. However, the development of rapid separation and easy clinical labeling methods is not yet well established. Under such situation, products from the same ethnic group or country are now recommended by the World Health Organization as an alternative preparation. This article describes the on-site preparation of Tc-99m HSA from locally supplied serum products. Different formulations were prepared and the labeling efficiency and stability were examined. Radio-labeling efficiencies were more than 90% in all preparation protocols, except for one that omitted the stannous solution. The most cost-effective protocol contained HSA 0.1 mg, treated with stannous fluoride 0.2 mg, and mixed with Tc99m pertechnetate 30 mCi. A biodistribution study was performed in rats using a gamma camera immediately after intravenous administration of radiolabeled HSA. Tissue/organ uptake was obtained by measuring the radioactivity in organs after sacrificing the rats at timed intervals. The biologic half-life was about 32 min, determined from sequential venous blood collections. These data indicate that our preparation of Tc-99m HSA is useful and potentially applicable clinically. In addition, this on-site preparation provides the possibility of labeling a patient's own serum for subsequent clinical application.

show abstract

Endotoxin Testing

Cited by 14 publications

References 43 publications

In vitro pyrogen test—A new test method for solid medical devices

In vitro pyrogen test—A new test method for solid medical devices

Pharmaceutical Aspects of Hemoglobin-Based Oxygen Carriers

On-Site Preparation of Technetium-99m Labeled Human Serum Albumin for Clinical Application

Contact Info

Product

Resources

About