Table 1.
Accuracy and Stability Test Results of the Established Microplate CLIA Method by Using the Chinese National Reference Substances for T. pallidum Diagnosis
| Accuracy | |||||
|---|---|---|---|---|---|
| Nat. Ref. Stand. | Lot 111110 | Lot 111120 | Lot 111130 | Lot 111110 | |
| Neg. Concord. | 20/20 | 20/20 | 20/20 | 20/20 | 20/20 |
| Pos. Concord. | 10/10 | 10/10 | 10/10 | 10/10 | 10/10 |
| Sen. Concord. | No. 1 + | + | + | + | + |
| No. 2 + | + | + | + | + | |
| No. 3 +/– | – | – | – | – | |
| No. 4 – | – | – | – | – | |
| Pre. Concord. | Intra. CV ≤ 15.0% | 4.68% | 5.56% | 5.77% | 8.91% |
| Intra. CV ≤ 20.0% | 12.8% among three lots of reagents | ||||
Nat. Ref. Stand., national reference standard; Neg., negative; Pos., positive; Sen., sensitive; Pre., precision; Concord., Concordance; Intra. CV, intraassay coefficient of variation; Inter. CV, interassay coefficient of variation.