Abbott announces the validation of its Panbio ™ COVID-19 Ag rapid test device, for two new uses for the detection of the SARS – CoV-2 virus: asymptomatic testing and nasal self-sampling under the responsibility of a healthcare professional . These new indications are in line with the recent publication of the HAS which recommends large-scale targeted iterative screening.
Panbio COVID-19 Ag’s label has been updated with clinical data on asymptomatic individuals, enabling massive screening campaigns for people who are currently not showing symptoms. According to a recent study published in JAMA, 2 it is estimated that at least 50% of infections with the COVID-19 virus come from exposure to asymptomatic people.
The other indication update concerns self-sampling under the supervision of a healthcare professional. Self-sampling with an easy-to-use nasal swab improves patient comfort and reduces the risk of accidental virus exposure to caregivers, allowing them to maintain their distance during the testing procedure.
“The use of the test for asymptomatic and self-sampling are important advances in the field of rapid screening which will make it possible to broaden the screening campaigns to fight against the epidemic”, declared Jean Baptiste Nivet, CEO of Abbott Rapid Diagnostic in France. “Now that Abbott’s Panbio rapid antigen test is approved for asymptomatic people, it becomes an even more valuable tool to allow a return to work, school, travel or any other activities of daily living, in any security “.
Since last August, Abbott has shipped 200 million Panbio rapid antigen tests to 120 countries in Europe, America, Asia and Africa. Healthcare professionals around the world have seen the test’s clinical effectiveness in detecting infections with the COVID -19 virus. In coordination with the Global Fund, the World Health Organization and the Bill & Melinda Gates Foundation, Abbott continues to make Panbio antigenic rapid tests available to low and middle income countries.
Since the onset of the pandemic, Abbott has developed the most advanced and comprehensive line of COVID-19 tests across all of its testing platforms: high throughput molecular testing on its m2000 ™ RealTime and Alinity ™ laboratory systems , serological tests on its Alinity ™ i and ARCHITECT® i1000SR and i2000SR instruments, rapid molecular tests on the ID NOW ™ instrument, and the Panbio ™ COVID-19 Ag Rapid Test Device.
About the Panbio COVID-19 Ag Rapid Test
The Panbio COVID-19 Ag Rapid Test is a lateral flow test for rapid and qualitative detection of the SARS-CoV-2 virus. A nasal or nasopharyngeal swab is used to collect samples from individuals. Test results are delivered in just 15 minutes, without instruments.
Negative results should be combined with clinical findings, patient history, and epidemiological information. Negative results do not rule out infection with the COVID-19 virus and cannot be used as the sole basis for treatment or other management decisions.
The clinical performance of the Panbio COVID-19 Ag rapid test was determined by testing 483 asymptomatic people for SARS-CoV-2 antigen and comparing the results with a reference PCR method.
Positive results (n = 50) were stratified counting cycle cutoffs (Ct) to understand the correlation between product performance and the amount of virus present in the clinical sample. The value of Ct is inversely proportional to the concentration of the virus.
The specificity of the test on 433 negative samples was 100.0%, which means that no false positives were identified. The results for sensitivity were:
- 93.8% of the 32 samples had a Ct value less than or equal to 30
- 80.0% of 40 samples had a Ct value less than or equal to 33
- 66.0% of 50 samples were positive (for all Ct counts)
Panbio COVID-19 Ag has received CE marking for use in supervised nasal self-sampling on asymptomatic and symptomatic individuals. Abbott has submitted emergency use list documentation to the World Health Organization for the two new indications for testing in asymptomatic people and self-sampling
The Panbio COVID-19 Ag Rapid Test is available in all countries other than the United States and is subject to local regulatory and business requirements.
ABBOTT
1 The Panbio COVID-19 Ag Rapid Test Device is not approved for screening the blood supply.
2 JAMA, SARS-CoV-2 Transmission from People Without COVID-19 Symptoms, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2774707.
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