Endotoxin

Test Code: 3046

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Clinical Utility

Quantitative determination of endotoxin in environmental samples by the Limulus Amoebocyte Lysate method.

Procedure

Limulus Amoebocyte Lysate method: The activation, from proenzyme to active enzyme, of amoebocytes protein isolated from horseshoe crab, is sensitive to catalysis by bacterial endotoxin. The initial rate of activation is determined by the amount of endotoxin present. The activated enzyme catalyzes the release of strongly colored p-nitroaniline (pNA) from the colorless substrate Ac-Ile-Glu-Aa-pNA, and the rate of release of pNA is monitored photometrically at 405 nm. Activity produced by endotoxin-containing samples is quantified by comparison to standards of known endotoxin concentration. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Turnaround Time

5-7 business days from receipt of specimen

Specimen Information

Specimen Type	Order Code	CPT Code	NY Approved	Volume	Assay Range	Special Instructions
	3046	0	No	2 mL	0.05-50.0 EU/mL	Liquid samples should be collected in sterile pyrogen-free glass containers. Do not use plastic containers. Use aseptic techniques. Direct contact with latex or other exam gloves should be avoided as these gloves often carry traces of endotoxin which may be transferred to the sample. Samples should be stored and shipped at 2-8°C.

0.05-50.0 EU/mL

Causes for Rejection

Samples in non-glass containers and samples received ambient will be rejected.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor Eurofins' interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for general informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.