Monday, July 12, 2021

Abbott Launches Panbio™ COVID-19 Antigen To Strengthens Rapid Diagnostics Portfolio To Support Testing At Home, Work And Clinics

* Panbio™ COVID-19 Antigen Self-Test has received CE Mark for over-the-counter use in adults and children, with or without symptoms

* The self-test features a minimally invasive nasal swab and delivers results in as early as

15 minutes with no instrumentation, using proven Abbott lateral flow technology

* Automatic reading of test results and fast, easy online reporting to Indian Council of Medical Research (ICMR) via Abbott’s NAVICA™ reporting app

* In clinical evaluations with self-test users, the Panbio Self-Test correctly identified

95.2% of positive samples and 100% of negative samples

Abbott has announced the launch of Panbio™ COVID-19 Antigen Self-Test for the detection of the SARS-CoV-2 virus in adults and children with or without symptoms. In alignment with the current ICMR advisory on self-use, these tests will be made available to ramp up testing of symptomatic and asymptomatic individuals and contacts of confirmed coronavirus cases.

Abbott will deliver millions of Panbio COVID-19 Rapid Antigen Tests available for self-use to ease the burden on healthcare systems in urban and rural India. Since the tests provide critical information at a point in the infection cycle when people are at the highest risk of spreading the disease, they can be a powerful tool to slow the spread of infection.

"India needs a clear, multi-pronged COVID-19 response strategy," said Professor Nirmal Kumar Ganguly, former Director General, ICMR. "Scaling access to easy, accurate and fast testing can speed up the country’s preparedness and curb community contagion. Self-testing at home empowers individuals with the ability to carry out the first line of protection against disease transmission. This not only streamlines the process of isolation, tracing and tracking but also supports people in taking charge of their own health and enhances participation of individuals willingly."

In India, Abbott will offer self-tests for use at home, assisted professional testing at point of care and laboratories, as well as workplace testing to help enable a sense of normalcy in returning to places of employment.

"Rapid antigen testing is critical in the fight against COVID-19 and Abbott is delivering a variety of diagnostics options at a critical juncture in the pandemic," said Sanjeev Johar, divisional vice president of Abbott’s rapid diagnostics business in Asia Pacific. "Self-testing is a proven tool that provides an added layer of defense along with public health protocols and the vaccine roll out."

Self-Tests enable fast testing and reporting to help curb the spread of infection

The Panbio COVID-19 Antigen Self-Test is easy-to-use, and people can take the test by using a simple nasal swab (not the deep nasopharyngeal swab) while following the Instructions for Use steps on pack. For children younger than 14 years, an adult caretaker should help collect the nasal samples and conduct the test procedures.  The kit contains all the materials required including nasal swabs, test devices and reagent ampules. No additional instrumentation is required to conduct the test.

Self-test kits are offered in packages of one, four, 10 and 20 tests. With results in just 15 minutes, the Panbio COVID-19 Antigen Self-Test enables people who test positive to immediately isolate so that they do not infect others, rather than waiting days for results.

The test is to be used along with Abbott’s NAVICA mobile app, available in the Google Play and Apple app store. The app offers a simple and streamlined process of self-registration, automatic reading of results and easy reporting as per ICMR guidelines. Panbio Self-Tests will be available via retail pharmacies and through e-commerce platforms, as well as through organizations and institutions.

Rapid point of care testing delivers timely health information to inform treatment

Abbott has multiple professional use diagnostic test options in India that deliver reliable, on-the-spot results. Abbott offers the Panbio™ COVID-19 Ag Rapid Test Device for professional use. This version of the test – which is scientifically identical to the self-test– can be administered by health professionals on adults and children, with or without symptoms. Like the Panbio Self-Test, the professional test offers a minimally invasive nasal swab option for the assisted, supervised sample collection, which can help people who are not comfortable with the deep nasopharyngeal swab. It delivers results in 15 minutes.

The Panbio professional test demonstrated 95.7% sensitivity and 97.6% specificity when benchmarked against RT-PCR tests, indicating high reliability.[i]  Abbott is the only diagnostics manufacturer to provide performance data on a rapid antigen test specific for use on children who are 15 years and younger, including infants. Panbio has CE Mark for asymptomatic use and supervised nasal swab collection and is on the World Health Organization (WHO) Emergency Use Listing.

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