Limulus Amebocyte Lysate, Endotoxin

Test Code

14453

CPT Codes
87999<br /> **This test is not available for Florida or New York patient testing.**

Preferred Specimen

5 mL frozen aqueous solutions submitted in a nonpyrogenic, plastic, leak-proof container used in patient management

Minimum Volume

3 mL

Transport Temperature

Frozen

Specimen Stability

Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Body fluids • Glass tubes

Methodology
Kinetic

Setup Schedule

Set up: Tues-Sat; Report available: 1-3 days

Clinical Significance

Amoebocyte lysate from the horseshoe crab (Limulus polyphemus) is a sensitive indicator of the presence of endotoxin. A limulus amoebocyte lysate (LAL) test can be used to test for endotoxins in dialysis water as well as biological products, parenteral drugs, and medical devices. This test is not intended for detecting endotoxin in clinical samples or diagnosing disease [1].

Bacteria that contaminate dialysis fluid are mainly gram-negative. Contamination usually comes from water used to prepare for dialysis fluid. Endotoxins can enter the bloodstream from the dialysis fluid. Endotoxins are associated with chronic inflammation that may lead to increased cardiovascular risk and mortality in hemodialysis patients [2,3].

Bacterial derivatives other than lipopolysaccharides can also cause inflammation in hemodialysis patients but are not detectable by this assay [4].

References
1. Limulus amebocyte lysate (LAL) Kinetic-QCL(TM). Package insert. Lonza Walkersville, Inc; 2019.
2. Arizono K, et al. Blood Purif. 2004;22 Suppl 2:26-29.
3. Zimmermann J, et al. Kidney Int. 1999;55(2):648-658.
4. Glorieux G, et al. Nephrol Dial Transplant. 2012;27(11):4010-4021.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.