| Cause | FP | FN |
|---|---|---|
| Inappropriate storage conditions (see question 53) | ||
| Shorter incubation time | ||
| Incubate at a lower temperature than 37 °C | ||
| Incubate at a higher temperature than 37 °C | ||
| Measurement of the chemiluminescent signal without having incubated the sample according to the N-Light™ L.monocytogenes test Instructions For Use (IFU) | ||
| Measu Immediate or delayed measurement of the sample after tablet release contrary to the specifications in the N-Light™ L.monocytogenes test Instructions For Use (IFU) |
Any deviation from the N-Light™ L.monocytogenes test IFU can lead to FP or FN results.
The growth of certain Bacilli, S.aureus, and L.ivanovii could theoretically cause positive signals as they produce the same enzyme PI-PLC which cleaves the AquaSpark™ molecule and leads to the expression of chemiluminescent light. However, the proprietary NEMIS enrichment broth contains both antibiotics and bacteriophages that specifically eliminate these microorganisms.
