Table 6 Test reproducibility.
Determine Syphilis TP Abbott Labs | Syphilis Fast Diesse Diagnostica | Espline TP Fujirebio Inc | Syphicheck‐WB Qualpro Diagnostics | SD Bioline Syphilis 3.0 Standard Diagnostics | Visitect Syphilis Omega Diagnostics | |
---|---|---|---|---|---|---|
Lot‐to‐lot variation* | 1/50 | 4/50 | 3/50 | 0/50 | 3/50 | 1/50 |
Day‐to‐day variation† | 0/45 | 3/45 | 1/45 | 1/45 | 0/45 | 3/45 |
Operator‐to‐operator at reference labs‡ | 1/40 | 0/40 | 0/40 | 3/40 | 1/40 | 4/40 |
Operator‐to‐operator at sites | 4/789 | 20/789 | 0/789 | 6/789 | 0/789 | 5/789 |
Values given as number of discordant results/total number of tests performed.
*Two lots of rapid tests performed using the same 25 sera.
†Nine sera tested on 5 days.
‡Ten sera run by 2 operators at each of 2 reference laboratories.