Test Catalog

Test Id : FLLYS

Limulus Amebocyte Lysate, Endotoxin

Method Name
A short description of the method used to perform the test

Kinetic

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

No

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Limulus Lysate

Specimen Type
Describes the specimen type validated for testing

Varies

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

3 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Glass tubes Reject
Body fluids Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Frozen 72 hours

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

<0.05 EU/mL

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

Referral

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Tuesday-Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

3 to 7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Quest Diagnostics Nichols Institute

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87999

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
FLLYS Limulus Lysate 33643-8
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
FLLYS Limulus Lysate 33643-8

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2025-08-28