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Endotoxin Assay : 1000298
Test CodeENDTX or 1000298
Alias/See Also
Dialysate
CPT Codes
87999
Instructions
Dialysis water or laboratory water:
Collect in: Endotoxin-free containers [obtained from laboratory]. Do NOT use any other containers.
1. Dialysate: Samples shall be collected where a dialysis machine connects to the water distribution loop, from a sample point in the distal segment of the loop or where water enters a mixing tank. [from: ANSI/AAMI/ISO 13959:2009]
2. Laboratory water:
a. Water sample should be collected, using aseptic technique, into sterile specimen containers at each point-of-use site. Sample must be collected in a manner that prevents contamination by contact with skin or the environment.
b. Water samples intended to evaluate water as used in laboratory procedures should be collected from points of use in a manner consistent with the way it would be drawn normally.
c. If water is sampled from a port intended only for the purpose of microbial testing of the water within the distribution or storage system, then that port should be disinfected (usually with isopropyl alcohol) prior to sampling, and the port flushed thoroughly to remove the disinfectant before the water sample is drawn. [from: CLSI document C03-A4-AMD,2012]
NOTE:
Water samples from dialysis machines or dialysate samples should be collected aseptically in sterile, endotoxin-free/pyrogen-free containers to minimize the adsorption of endotoxin to container surfaces. The silicone lubricant in syringes is known to inhibit the assay/test if the sample is held too long in the syringe.
Collect in: Endotoxin-free containers [obtained from laboratory]. Do NOT use any other containers.
1. Dialysate: Samples shall be collected where a dialysis machine connects to the water distribution loop, from a sample point in the distal segment of the loop or where water enters a mixing tank. [from: ANSI/AAMI/ISO 13959:2009]
2. Laboratory water:
a. Water sample should be collected, using aseptic technique, into sterile specimen containers at each point-of-use site. Sample must be collected in a manner that prevents contamination by contact with skin or the environment.
b. Water samples intended to evaluate water as used in laboratory procedures should be collected from points of use in a manner consistent with the way it would be drawn normally.
c. If water is sampled from a port intended only for the purpose of microbial testing of the water within the distribution or storage system, then that port should be disinfected (usually with isopropyl alcohol) prior to sampling, and the port flushed thoroughly to remove the disinfectant before the water sample is drawn. [from: CLSI document C03-A4-AMD,2012]
NOTE:
Water samples from dialysis machines or dialysate samples should be collected aseptically in sterile, endotoxin-free/pyrogen-free containers to minimize the adsorption of endotoxin to container surfaces. The silicone lubricant in syringes is known to inhibit the assay/test if the sample is held too long in the syringe.
Transport Container
Submit specimen (Min. 30 mL) in Endotoxin-free container.
Transport Temperature
Refrigerated.
Specimen Stability
Samples can be stored for 24 hours refrigerated. For longer storage, samples may be frozen. Specimens should be tested as soon as possible after collection. Transport as quickly as possible.
Methodology
Gel clot formation (Limulus Amebocyte Lysate (LAL)Assay, Qualitative)
Setup Schedule
Sunday - Saturday
Report Available
1-2 days
Reference Range
Negative (<1.0 EU/ mL of Endotoxin)
Performing Laboratory
med fusion
