- Matrix interference i.e. by cocoa powder. A 1:10 dilution should be carried out before testing the sample. Fatty products or highly coloured products may also cause matrix interference.
- Operator error as the test is very sensitive.
- If the equipment (heating blocks and reader) or pipettes are out with calibration and the lysis buffer is being under delivered or the heating block or reader are not at the correct temperature.
- Abuse of the test kit i.e. leaving the kit out of the fridge or putting the kit at the back of the kit where it may freeze and crystallise the pellets. The pellets should be tested for consistency.
- If the control line does not rise this may be due to a pellet not working properly.
- If debris has been pipetted from the lysis tube, this could interfere with the testing.
- If the positive and/or negative controls are not working properly, this may cause invalids.
- If the latest version of the test type package and ISO profile are not being used, this may cause invalids.
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