Evaluation of PCL rapid point of care antigen test for detection of SARS‐CoV‐2 in nasopharyngeal swabs

Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda

“…These RDTs however had good specificity, with only three showing a specificity slightly lower than that reported in the IFUs. Poor performance in real-world settings compared to that found in the manufacturer’s IFUs has also been reported by others [ 4 , 7 , 8 , 15 – 18 ], emphasizing the need for performance evaluations of antigen RDTs in-country before adoption for use. In our study, we noted that the sensitivity of all seven Ag RDTs improved at lower qRT-PCR Ct values and this has also been observed in other studies [ 6 – 8 , 18 – 20 ].…”

“…Poor performance in real-world settings compared to that found in the manufacturer’s IFUs has also been reported by others [ 4 , 7 , 8 , 15 – 18 ], emphasizing the need for performance evaluations of antigen RDTs in-country before adoption for use. In our study, we noted that the sensitivity of all seven Ag RDTs improved at lower qRT-PCR Ct values and this has also been observed in other studies [ 6 – 8 , 18 – 20 ]. Lower qRT-PCR Ct values in most cases correlate with higher viral loads and hence with increased transmissibility of the virus, usually in the early phases of the infection [ 21 ].…”

“…Although manufacturer’s reported high sensitivity (60.0–100%) and specificity (97.8–100%) for their Ag RDTs ( S1 Table ), the limited peer reviewed reports on their performance in clinical settings [ 4 – 8 ] showed conflicting performance.…”

Field clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a living systematic review of trials up to 17th of August, 2021

“…However, it appears that samples were pre-selected (N=100) and tested in a laboratory after being tested by a centralised PCR assay. We therefore believe that this study, which showed a sensitivity of 68% and a specificity of 100%, is unlikely to accurately reflect results in the field. A different methodology was used by Rastawicki et al 121 evaluating the PCL COVID-19 Ag rapid fluorescent immunoassay (FIA); 4 swabs were collected in the course of 2 days and antibodies were also evaluated. We considered the comparison between RT-PCR and antigen test straightforward enough for the trial to be included in our table, despite the low number of patients enrolled. The study by Regev-Yochay 201 could not be included as multiple antigen platforms were classified as a whole, and individual data for individual assays was not available. The study by Smithgall et al 202 regarding the Cepheid Xpert Xpress and Abbott ID Now was not included as only remnant patient samples were tested; therefore, the platforms were not evaluated in a proper clinical environment.…”

“…A different methodology was used by Rastawicki et al 121 evaluating the PCL COVID-19 Ag rapid fluorescent immunoassay (FIA); 4 swabs were collected in the course of 2 days and antibodies were also evaluated. We considered the comparison between RT-PCR and antigen test straightforward enough for the trial to be included in our table, despite the low number of patients enrolled.…”