Endotoxin Detection by Limulus Amebocyte Recombinant Factor C
Also known as: ENDOTOXIN
Use
This is a quantitative test used to detect gram-negative endotoxins in hemodialysis reuse water, which is critical for patient management by ensuring the water's safety and compliance with USP standards. The test measures endotoxin levels to assess whether they are within the acceptable limit of 2.00 EU/mL, ensuring that reuse water is suitable for hemodialysis without causing harm to patients.
Special Instructions
Specimen sterility must be maintained to prevent false positive results due to contamination by exogenous gram-negative bacteria. Separate specimens must be submitted when multiple tests are ordered, and the specimen must remain critically frozen during transport.
Limitations
The test is not suitable for clinical specimens and is only applicable for hemodialysis reuse water. Unacceptable conditions include biological specimens and the use of glass tubes or vials, which can compromise test integrity. The ambient or refrigerated conditions are unacceptable, and the sample must remain frozen to maintain stability for up to one month.
New York Approved
Methodology
Other
Biomarkers
LOINC Codes
- 33643-8
- 33643-8
Result Turnaround Time
2-7 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
3 mL
Minimum Volume
1 mL
Container
plastic tube
Storage Instructions
CRITICAL FROZEN
Causes for Rejection
Biological specimens, glass tubes/vials
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Unacceptable |
| Refrigerated | Unacceptable |
| Frozen | 1 month |