Biomedical companies catch and bleed horseshoe crabs for the production of Limulus amebocyte lysate (LAL), a product used for protecting public health (Berkson and Shuster, 1999). LAL is a clotting agent, derived solely from horseshoe crab blood cells, which is used to detect the presence of pathogenic gramnegative bacteria in injectable drugs and implantable medical and dental devices (Mikkels...

On June 22, 2011, the U.S. Food and Drug Administration (FDA) withdrew the “Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-product Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices,” which was issued in 1987. Elements of the Guideline continue to impact current methods because they can be found in other references relied on by the indus...

The Limulus amebocyte lysate (LAL) assay is a sensitive method for detecting endotoxin. Using gram-negative (GN) bacteremia as the basis for comparison, concordance with endotoxemia in 45 studies could be expressed as an odds ratio. Calculation of summary odds ratios by the Mantel-Haenszel-Peto method indicated that the concordance of the results was no higher by the chromogenic LAL assay than ...

Progressive pyogranulomatous osteomyelitis involving the mandible or maxilla of captive macropods, referred to as "Lumpy jaw disease (LJD)", is one of the most significant causes of illness and death in captive macropods. The aim of the present study was to evaluate the relationship between the severity of LJD and plasma endotoxin activity in kangaroos. Plasma samples obtained from moderate (n=...

A simple and rapid method has been developed for testing bacterial endotoxin in hyaluronic acid (HA)-based medical devices. High-molecular-weight HA (HMW HA) in solution or HA-based medical devices was digested by the enzyme hyaluronidase to reduce solution viscosity by truncating the long chains of HA and to test for bacterial endotoxin. The bacterial endotoxin level was detected and measured ...

The objective of this study was to fill in additional knowledge gaps with respect to the extraction, storage, and analysis of airborne endotoxin, with a specific focus on samples from a dairy production facility. We utilized polycarbonate filters to collect total airborne endotoxins, sonication as the extraction technique, and 0.05% Tween 20 in pyrogen-free water (PFW) as the extraction solutio...

A total of 120 Limulus amoebocyte lysate (LAL) determinations were made on plasma obtained from normal, healthy human blood donors. Results demonstrated a mean endotoxin level in blood of 0.02 to 1.57 pg/ml. The amount of Escherichia coli endotoxin added to human plasma samples can be quantitated by both nephelometry and turbidimetry. Endotoxin-spiked samples were shown to be significantly diff...

The measurement of airborne endotoxins is thus far not standardized. Earlier studies reported higher endotoxin yields when Tween 20 was added to the media used for filter extraction and in the Limulus amebocyte lysate (LAL) assay. This study compared four common media and assessed the effects of Tween during extraction and analysis separately. Parallel airborne dust samples from five work envir...

The aim of this study was to assess workers' exposure to endotoxins and peptidoglycans, as well as associations between workers' reported symptoms and the detected bacterial exposures. From the filter samples, biologically-active endotoxins were analysed with the Limulus amebocyte lysate (LAL) assay. The total amount of endotoxins was analysed as 3-hydroxy (OH) fatty acids with a gas chromatogr...

We have developed a novel method for detection of endotoxin with extra-high sensitivity by using substitutional stripping voltammetry (SSV). In this method, a p-aminophenol (pAP) conjugated peptide (Boc-Leu-Gly-Arg-pAP; LGR-pAP) was used as a substrate for a protease, which is activated at the last step of the endotoxin-induced Limulus amebocyte lysate (LAL) cascade reaction. Extra-highly sensi...