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Test ID FLALA Limulus Amebocyte Lysate (Endotoxin)

Profile Information

Test ID Reporting Name Available Separately Always Performed
FLAL Limulus Lysate Assay No Yes
FLAL2 Limulus Lysate No No
FLAL3 Limulus Lysate No No
FLAL4 Limulus Lysate No No

Testing Algorithm

If additional specimen dilutions are required to obtain an accurate result, up to 3 additional dilutions could be performed, each at an additional charge.

Method Name

Kinetic

Reporting Name

Limulus Amebocyte Lysate, Endotoxin

Specimen Type

Varies

5 mL aqueous solution used in patient management. Send solution frozen in non-pyrogenic, plastic container.

 

NOTE: 1. Submit name of aqueous solution, and the diluent if applicable.

           2. Body fluids are not acceptable.

           3. Glass vials are not acceptable.

Specimen Minimum Volume

3 mL

Specimen Stability Information

Specimen Type Temperature Time
Varies Frozen 30 days

Reference Values

LEVEL DETECTED                   INTERPRETATION

<0.05 EU/mL                             None Detected

0.125 EU/mL                             Action level for dialysis water

<0.25 EU/mL                             Maximum allowable level for dialysis water and USP acceptable limits for injectable or irrigation water

0.25   EU/mL                             Action level for dialysis fluid

<0.50 EU/mL                             Maximum allowable level for dialysis fluid and USP acceptable limits for inhalatory water.

2.00   EU/mL                             Acceptable upper limit for Hemodialysis reuse water.

 

The LAL is used as a quantitative test to detect gram-negative endotoxin in aqueous solutions used in patient management. The LAL assay is not recommended for serum or plasma samples due to the presence of inhibitory factors. It is essential to maintain specimen sterility and prevent false positive results from exogenous gram negative bacteria.

 

Day(s) Performed

Monday through Friday

Report Available

1 - 4 days

Performing Laboratory

Focus Diagnositics, Inc.

CPT Code Information

No CPT code available on Non-Biological specimens

NY State Approved

Yes