Group | Aim | Participants and Specimens | Sample size for each neutralizing titer | ||
---|---|---|---|---|---|
Total samples | Positive | Negative | |||
1 | Detection limit | 2 | one serum sample and one neutralizing antibody from two convalescent patients, respectively; | 0 | – |
2 | Comparison between UPT-POCT and ELISA | 39 | 39 samples, from 27 patients at acute phase (7–10 days) | 0 | – |
3 | Definition of cutoff of UPT-POCT for detecting serum sample | 210 | 140 samples, from 140 COVID-19 patients at different courses | 70 samples, from 70 healthy people | – |
4 | Diagnostic performance of UPT-POCT in the hospital settings | 782 | 387 samples, from 387 COVID-19 patients’ samples at different courses | 395 samples, from 395 healthy people | – |
5 | The relationship between RBD-specific total antibodies and neutralizing activity | 812 | 528, from recovered or recurrent patients* | 284 | ≥ 14 |
UPT-POCT for predicting the protective effects in COVID-19 patients | 312 | 312 serum samples from 213 recovered and 99 PCR re-positive COVID-19 patients* | 0 | ≥ 8 | |
6 | UPT-POCT for predicting the protective effects in vaccinated individuals | 35 | 35 vaccinated individuals with NAb titers equal or higher than1:32 | 0 | ≥ 5 (except the titer 1:32) |