| 1. |
Incubator design of the microplate photometers affects the LAL-endotoxin test results (see, Fig. 11 - 36), |
| 2. |
Both TECAN Sunrise BioTek ELx808i have met their respective specifications in empty state for temperature accuracy & temperature variability (see, Fig. 1 - 10), |
| 3. |
TECAN Sunrise has shown better temperature distribution than BioTek ELx808i, if the well-to-well temperature measurements are compared of the test solutions during the LAL-endotoxin Kinetic Test Protocol (see, Fig. 40 - 47), |
| 4. |
The dynamic effects of evaporation from the test solutions affected the temperature variability (see, Fig. 48 - 59), |
| 5. |
Turbidimetric LAL reagents from the various manufacturers behaved differently to the temperature variability; - Cambrex's LAL reagent - Manufacturer B - has shown the greatest sensitivity and the largest deviation relative to temperature induced changes in the reaction time (see, Fig. 34 - 36), |
| 6. |
Standard & sample topology can contribute to the inaccuracy of the results, |
| 7. |
The general application of the Power Curve is not supported by the experiments, |
| 8. |
Opulus Temperature Correction (OTC) can improve the results significantly (see, Fig. 37 vs. 38), |
| 9. |
Temperature of the test solutions during kinetic runs, just as pH, is a Critical Control Point in the Method Development & Method Validation. |
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