Test ID: FLALA
Limulus Amebocyte Lysate (LAL) Assay, Quantitative
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| 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 Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
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 A short description of the method used to perform the test
Chromogenic Assay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
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 Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
Specimens Other Than: Water or dialysis solution
Anticoagulants Other Than:
Hemolysis:
Thawing:
Lipemia:
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Frozen | |
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.
LEVEL DETECTED INTERPRETATION
<0.05 EU/mL None Detected (Negative)
0.25 EU/mL USP acceptable limits for
injectable or irrigation water.
0.50 EU/mL 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.
Test Performed by: Focus Diagnostics, Inc.
5785 Corporate Ave.
Cypress, CA 90630-4750
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Performing Laboratory Location The location of the laboratory that performs the test
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
No CPT code available on Non-Biological specimens
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| Z0830 | Specimen Type | In Process |
| Z2440 | Limulus Lysate | In Process |
| Z2441 | Limulus Lysate | In Process |
| Z2442 | Limulus Lysate | In Process |
| Z0831 | Diluent | In Process |
| Z0832 | Pharmacopeia Endotoxin Limit | In Process |
| Z0819 | Limulus Lysate | In Process |
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