Instructions - Print PDF

1. Preheat incubator (dry or wet bath) to 37°C
2. Collect sample with pyrogen-free container - caution: some syringes contain silicone, which can inhibit the test. Tester should take measures to not contaminate sample.
3. Use a permanent marker to label sample and control tubes with test location – avoid marking over 0.5mL and 0.25 mL lines).
4. Remove and discard stoppers of one SPL (blue capped sample tube) and one PPC (red capped Positive Product Control tube). Do not touch rim of tubes while removing stoppers.
5. Open 1 pipette without contaminating the tip or neck of the pipette.
6. Draw sample water/dialysate up to the.5 mL mark (located near the middle of the pipette) and transfer it into the SPL tube. (do not lay pipette down, you will use it again in 60 seconds)
7. Gently mix the contents of the tube by lightly tapping the bottom several times with your finger. The contents of the tube should completely dissolve within 60 seconds.
8. Using the same pipette, remove .25 mL (unlabeled ring-mark below .5 mL on the pipette) of the liquid from the SPL tube and transfer it to the PPC (Positive Product Control) tube. Discard pipette.
9. Gently mix contents of the tube by lightly tapping bottom several times with your finger (60 seconds)
10. Immediately place both tubes in the incubator. Incubate at 37 ± °C for the amount of time indicated on the Certificate of Compliance included with the kit. Incubation times will vary with each lot number.
11. Remove both tubes and check results (invert over a discard container to check for clot formation).

RESULTS:
PPC (Positive Product Control) tube should clot. If it doesn't you have an invalid test. Repeat the test.

SPL (Sample) tube should not clot. A negative result means you have less than 1.0 EU/mL of endotoxin. If the SPL tube clots, your sample is contaminated and you should not use the water/dialysate.