Clinical Study
Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test
Table 4
Reproducibility of the LIAISON® Meridian H. pylori SA test assessed over 5 days at multiple sites.
| | Mean index value | Within run | Day to day within site | Site to site | Total | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Neg Ctrl | 0.07 | 0.004 | 5.10% | 0.002 | 2.10% | 0.009 | 12.50% | 0.010 | 13.90% | Pos Ctrl | 4.80 | 0.076 | 1.60% | 0.063 | 1.30% | 0.105 | 2.20% | 0.153 | 3.10% | Mod Pos sample #1 | 2.12 | 0.034 | 1.60% | 0.108 | 5.10% | 0.119 | 5.60% | 0.168 | 8.00% | Mod Pos sample #2 | 2.37 | 0.049 | 2.10% | 0.156 | 6.60% | 0.226 | 9.50% | 0.283 | 11.90% | High Neg sample #1 | 0.69 | 0.024 | 3.50% | 0.037 | 5.40% | 0.065 | 9.40% | 0.081 | 11.80% | High Neg sample #2 | 0.69 | 0.023 | 3.30% | 0.019 | 2.70% | 0.065 | 9.40% | 0.077 | 11.00% | Low Pos sample #1 | 1.21 | 0.031 | 2.50% | 0.029 | 2.40% | 0.093 | 7.70% | 0.109 | 9.00% | Low Pos sample #2 | 1.20 | 0.021 | 1.70% | 0.056 | 4.70% | 0.120 | 10.10% | 0.138 | 11.50% |
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