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Kunnskapsdokumenter i offentlig sektor

Evaluering

Evaluation of Abbot’s Panbio COVID-19 rapid antigen test in Norway

The Abbott PanbioTM COVID-19 Ag Rapid Test Device (Panbio rapid antigen test (RAT)) was compared to in- house SARS-CoV-2 PCR in an evaluation performed on 3991 samples from a test station in Oslo and 866 samples from outbreaks in Norway in the period October 30th to November 25th 2020. 250 samples (6.3 %) were positive at Aker test station and 60 (6.9 %) at the outbreaks all together. At Aker test station the over-all sensitivity was 74.4 % and the specificity was 99.9 %, compared to the PCR results from Oslo University Hospital. Positive and negative predictive values were 0.984 and 0.983, respectively, showing high accuracy of both positive and negative test results at the given prevalence (6,3%) at the time. In the outbreak material, the sensitivity was 70 %, and the specificity was 100 %. Due to the lower sensitivity of the Panbio RAT, we conclude that for diagnosing serious illness and hospitalized patients, PCR remains the preferred method. However, RATs have been launched for other purposes: Epidemiological surveillance and contact tracing. A lower sensitivity can be tolerated in this context and compensated for by higher availability, higher turnaround time and repeated testing. The Panbio RAT had a lower detection limit corresponding approximately to 1.4 million copies/mL. Studies have shown that clinical samples with less than 1 million copies/mL are unlikely to cultivate in the laboratory and thus also less likely to be infectious from one person to another. In the Aker test station material, the sensitivity of the Panbio RAT was 83.8 % for samples with a viral load above this limit, indicating that the majority of infectious individuals will be detected with the test. For patients symptomatic for less than five days, the sensitivity was 79.8 %. These sensitivity figures are within WHO’s guidelines for RATs used in surveillance. For subjects without symptoms, the sensitivity was only 55.3 %, showing that the Panbio RAT is best suited for use in symptomatic patients, and that PCR will be a necessary backup method if RATs are used in this group. Due to the lower sensitivity of the Panbio RAT, guidelines for correct use are important. Correct use of RATs will for example be highly influenced by the actual disease prevalence. RATs may prove to be valuable tools in controlling the COVID-19 pandemic.