Panbio antigen rapid test is reliable to diagnose SARS-CoV-2 infection in the first 7 days after the onset of symptoms

Abstract

Background: Real-time reverse transcription polymerase chain reaction (RT-qPCR) is the current recommended laboratory method to diagnose SARS-CoV-2 acute infection, several factors such as requirement of special equipment, time consuming, high cost and skilled staff limit the use of these time-consuming molecular techniques. A more rapid and high-throughput method is in growing demand Methods: Evaluate the performances of the Panbio COVID-19 AG Rapid Test Device (Nasopharyngeal), a rapid immunochromatographic test for the detection of SARS-CoV-2 antigen, in comparison to RT-qPCR. Results: The RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads. Conclusions: This assay seems to be an effective strategy for controlling the COVID-19 pandemic for the rapid identification and isolation of SARS-CoV-2 infected patients.

Real-World Clinical Performance of the Abbott Panbio with Nasopharyngeal, Throat and Saliva Swabs Among Symptomatic Individuals with COVID-19

“…3 Of the studies that examined positivity rate based on symptom duration, one study found no difference in positivity rate with duration of symptom onset 3 , whereas another found higher sensitivity in individuals with symptom onset < 7 days (sensitivity 86.5%) compared to individuals with symptom onset ≥ 7 days (sensitivity 53.8%). 4 We found no difference in Panbio sensitivity among individuals with symptoms > 7 days, but this was limited to a very small pool of samples (N=15). All studies, including ours, found decreases in Panbio sensitivity among SARS-CoV-2 samples with higher Ct values, with sensitivity dropping when Ct values are approximately > 26.…”

“…There were false negatives on the Panbio, with 14/17 (82.4%) having a Ct > by RT-PCR and 9/17 (52.9%) with Ct > 30 on RT been identified by the Panbio manufacturer or among previous Panbio publications within the literature. [2][3][4] The PPA of the Panbio varies in the literature from 72.6% to 86.5% among individuals with symptoms ≤ 7 days. [2][3][4] These studies varied in terms of their study design and reference standards used.…”

“…[2][3][4] The PPA of the Panbio varies in the literature from 72.6% to 86.5% among individuals with symptoms ≤ 7 days. [2][3][4] These studies varied in terms of their study design and reference standards used. All studies examined paired NP swabs tested with the Panbio and a PCR-based platform,…”

“…The copyright holder for this preprint this version posted January 4, 2021. ; https://doi.org/10.1101/2021.01.02.21249138 doi: medRxiv preprint with two of the three studies using the Allplex (Seegene, South Korea). 3,4 One study used the VitaPCR SARS-CoV-2 (Credo diagnostics, Singapore) that has limited data available on its performance, which may potentially explain why 7 samples were Panbio positive but VitaPCR SARS-CoV-2 negative. 9 Gremmels et al performed testing on the Panbio up to 2 hours from collection, which may account for the lower sensitivity detected (72.6%).…”

“…The few published studies have demonstrated Panbio sensitivity ranges from 72.6% -86.5% among symptomatic individuals or exposed asymptomatic individuals. [2][3][4] We sought to assess the positive percent agreement (PPA) of the Panbio by comparing its performance to RT-PCR testing among individuals in the community using two separate evaluations. The first by testing individuals with recently confirmed COVID-19 while adhering as closely as possible to manufacturer recommendations (testing of symptomatic individuals within 7 days of symptom(s) onset).…”