Evaluation of the Panbio™ rapid antigen test for SARS-CoV-2 in primary health care centers and test sites

Abstract

BackgroundRapid antigen tests (Ag-RDT) are emerging as new diagnostic tools for COVID-19 and real-world evaluations are needed to establish their performance characteristics.Main objectiveTo evaluate the accuracy of the Panbio™ Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard.MethodsThis was a prospective diagnostic study conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing either for suggestive symptoms of infection or a close contact, were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio™ rapid antigen test kit for SARS-CoV-2. The sensitivity and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group.ResultsA total of 1369 participants were included; mean age 42.5 ± 14.9 years and 54.3% women. The overall prevalence was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms or close contact, and more than 70% had high viral loads. The overall sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was higher in symptomatic patients, in those arriving within 5 days since symptom onset and in those with high viral load.ConclusionAg-RDT had relatively good performance characteristics in suspected symptomatic patients within five days since the onset of symptoms. However, our results concludes that a negative Ag-RDT in these settings must be considered as presumptive.

Evaluation of a rapid antigen test (Panbio™ COVID-19 Ag rapid test device) for SARS-CoV-2 detection in asymptomatic close contacts of COVID-19 patients

“…[ 5 ] most participants (70.6%) were tested within 5 days of exposure. Sensitivity of the Panbio™ test was lower than was previously found [ [3] , [4] , [5] , [6] ] in symptomatic patients (around 80%), yet as reported for the latter patients, RAD sensitivity was directly related to the magnitude of SARS-CoV-2 RNA load in NP specimens. Such a striking difference might reflect dissimilarities across symptomatic and asymptomatic individuals in the kinetics of SARS-CoV-2 load in the upper respiratory tract [ 8 , 9 ].…”

“…(45.4%) [ 5 ] and Bulilete et al. (59.0%) [ 6 ], in apparently comparable cohorts. However, in two of these studies [ 4 , 5 ], the RAD test was carried out at a central laboratory, and timing of sample collection was not disclosed [ 4 , 5 ].…”

“…Moreover, two recently evaluated RAD assays (BD Veritor System and the Panbio™ COVID-19 Ag Rapid Test Device) may be used as a proxy for SARS-CoV-2 cultured from respiratory tract specimens, thus allowing reasonably accurate prediction of contagiousness [ 2 , 3 ]; yet this assumption awaits further validation in larger cohorts. The possibility of using RAD tests to identify SARS-CoV-2-infected asymptomatic contacts of COVID-19 patients is appealing, as it could effectively contribute to minimize community SARS-CoV-2 spread through early detection of highly infectious individuals [ 1 ], yet little is known about how RAD tests perform in this population group [ [4] , [5] , [6] ]. Here, we report on the performance of the Panbio™ COVID-19 Ag Rapid Test Device (Abbott Diagnostic GmbH, Jena, Germany) conducted at POC in this setting.…”

Extraction-free RT-LAMP to detect SARS-CoV-2 is less sensitive but highly specific compared to standard RT-PCR in 101 samples

“…Several jurisdictions use the Panbio Ag Rapid Test Device to identify positives early, assuming that negative results should be confirmed [ [34] , [35] , [36] ]. One recent study showed that none of those who were test discordant (positive by RT-PCR but negative using Panbio) had culturable virus in their sample [ 34 ], indicating potentially reduced transmissibility by individuals defined as “false negatives” in current protocols.…”

Is the glass half full? Extraction-free RT-LAMP to detect SARS-CoV-2 is less sensitive but highly specific compared to standard RT-PCR in 101 samples

“…The copyright holder for this preprint this version posted December 8, 2020. ; https://doi.org/10.1101/2020.12.07.20239558 doi: medRxiv preprint RT-LAMP vs. RT-PCR -Manuscript 10 jurisdictions are exploring use of PanBio Ag Rapid Test Device to identify positives early, assuming that negative results will need additional testing in order to be confirmed [26][27][28] .…”