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Test Code FLLYS Limulus Amebocyte Lysate, Endotoxin


Specimen Required


Specimen Type: Aqueous solutions

Container/Tube: Nonpyrogenic, plastic, leak-proof container

Specimen Volume: 5 mL

Collection Instructions: Send 5 mL frozen aqueous solutions collected in a nonpyrogenic, plastic, leak-proof container used in patient management.


Secondary ID

75928

Method Name

Kinetic

Reporting Name

Limulus Lysate

Specimen Type

Varies

Specimen Minimum Volume

3 mL

Specimen Stability Information

Specimen Type Temperature Time
Varies Frozen 72 hours

Reject Due To

Glass tubes Reject
Body fluids Reject

Clinical Information

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)

Reference Values

<0.05 EU/mL

Clinical Reference

1. Limulus amebocyte lysate (LAL) Kinetic-QCL(TM). Package insert. Lonza Walkersville, Inc; 2019

2. Arizono K, Nomura K, Motoyama T, et al. Use of ultrapure dialysate in reduction of chronic inflammation during hemodialysis. Blood Purif. 2004;22 Suppl 2:26-29

3. Zimmermann J, Herrlinger S, Pruy A, Metzger T, Wanner C. Inflammation enhances cardiovascular risk and mortality in hemodialysis patients. Kidney Int. 1999;55(2):648-658

4. Glorieux G, Neirynck N, Veys N, Vanholder R. Dialysis water and fluid purity: more than endotoxin. Nephrol Dial Transplant. 2012;27(11):4010-4021

Day(s) Performed

Tuesday-Saturday

Report Available

3 to 7 days

Performing Laboratory

Quest Diagnostics Nichols Institute

CPT Code Information

87999

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FLLYS Limulus Lysate 33643-8

 

Result ID Test Result Name Result LOINC Value
FLLYS Limulus Lysate 33643-8