​​​​AST became NATA accredited for the Bacterial Endotoxins test in waters and condensates in 2017. 

Bacterial Endotoxins are lipopolysaccharides that are structural components of many gram-negative bacterial cells. These components are pyrogenic, producing fever and toxic shock symptoms in humans. Endotoxins are released from damaged E.coli cells, sometimes even through the sterilising process.  Endotoxins are not readily inactivated at the temperatures used for disinfection or sterilisation, hence monitoring of Reusable Medical Devices (RMDs) cleaning quality is important, as recommended by standard AU/NZ 4187, and now standard AU/NZ​ 5369:2023. . 

AST also offers NATA accredited tests chemistry tests recommended in the standard. ​

The Bacterial Endotoxins test used at AST is a limulus amoebocyte lysate (LAL) gel formation method of assessing endotoxin concentration by kinetic turbidimetric reaction time. It is currently the analytical method of choice in Australia for quantitative endotoxin analysis. 

AST’s bacterial endotoxin test covers the concentration range 0.01 – 10.0 EU/mL (endotoxin units per mL), or samples can be diluted with distilled (sterilized) water to fall within this range. Thus complying with the limits for RMDs regulated requirements (0.25 EU/mL for RMDs and 30 EU/mL for thermolabile endoscopes). We regularly participate in peer-compared proficiency testing programs to maintain our NATA accreditation for this test.

Endotoxin white labelled tube

Samples for endotoxin analysis need to be taken in pyrogen-free sample tubes, AST’s white labelled 50mL tubes are quality checked and prepared for this purpose. When taking the samples please do not filter the sample as this can cause contamination. Once sampling is complete, samples need to be kept chilled and sent to the lab without delay.