Abbott’s Korea-imported PanBio Covid-19 self test

Panbio Coid 19 Test

With the Covid-19 self-testing landscape maturing in India, US-based pharma and diagnostics giant Abbott launched Panbio has launched a rapid antigen self-test kit in India for Rs 325 a test. This is the second such test kit available in the country after Pune-based Mylab Discovery Solutions launched CoviSelf in May.

CoviSelf is priced at Rs 250 per test.

Abbott’s Panbio, which will be imported from its Korean plant, will be available at retail outlets by the end of this month. Ambati Venu, Vice President, Pharmaceuticals, Abbott India said that compared to an RT-PCR test, this is much more economical, and therefore, access to a self-test will be much higher.

Venu added that PanBio would be distributed through collaboration between Abbott’s diagnostics and pharmaceutical divisions. “We will make the product available across half a million stores, which will not only cover semi-urban but also tier-2 and 3 cities where the access to RT-PCR was always a challenge,” he said. PanBio Self-Tests will be available via retail pharmacies and through e-commerce platforms, as well as through organizations and institutions.

The PanBio professional test demonstrated 95.7 per cent sensitivity and 97.6 per cent specificity when benchmarked against RT-PCR tests.

“Abbott is the only diagnostics manufacturer to provide performance data on a rapid antigen test specific for use on children 15 years and younger, including infants,” the company claimed. PanBio is on the World Health Organization (WHO) Emergency Use Listing.

Abbott expects to import a few million kits, but did not give a specific number. Venu said, “We are targeting three segments–home testing (self testing); assisted testing in clinics, labs etc; and third is ‘return to work’ segment. As corporates start opening up, airline travel picks up, educational institutions re-open, and hotels resume hosting clients, there is huge potential for such point of care Covid19 testing.”

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.”

The company has also priced the kit competitively. Johar elaborated: “The test is available in four pack sizes – one test pack is available for Rs 325 at the retail outlet to the consumer. As one moves to larger packs, the price per test becomes economical–for 20 test packs, it is Rs 280 per test.”

The PanBio Covid-19 Antigen Self-Test is easy-to-use, Abbott said. “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,” it explained.

The results come in 15 minutes, and the test is to be used along with Abbott’s NAVICA mobile app.

The app offers a process of self-registration, automatic reading of results and reporting as per ICMR guidelines. Since last August to date, Abbott has shipped 300 million PanBio Covid-19 Antigen Rapid tests for professional use in more than 100 countries across Europe, the Americas, Asia and Africa.

 

The Panbio COVID-19 Ag Rapid Test Device (nasal) is a high-performance rapid test for patients suspected of current COVID-19 infection.

The Panbio enables immediate treatment or isolation measures to minimize transmission.

  • Patient-friendly nasal or nasopharyngeal sample collection types.
  • Accessible, large-scale testing helps contain the virus spread.
  • Fast identification of potentially contagious individuals
  • Test results in 15 minutes
  • Deploy at large scale at point-of-care
  • Can be used in a wide variety of non-laboratory settings
  • No special/additional instruments required
  • Self-contained tube with “break off” swab minimizes staff exposure
  • The extraction tube is fully enclosed for disposal

 

Dive Brief:

  • Abbott Laboratories’ Panbio rapid antigen test misses half of COVID-19 cases in asymptomatic people, according to a study run by the Irish healthcare system.
  • The finding, which is in line with the results of a U.K. study of a rival test sold by Innova, led Ireland’s Health Service Executive to recommend against using single, standalone antigen kits for the purposes of asymptomatic screening.
  • HSE also assessed rapid antigen tests from companies including Abbott, LumiraDx and Roche in symptomatic patients, concluding that variation in the performance of the kits means they should not be considered interchangeable.

Dive Insight:

HSE carried out the study to assess whether rapid antigen tests have a role to play in the detection of COVID-19 in acute hospitals, meat processing plants and community swabbing centers. The study assessed the use of seven rapid antigen products to test symptomatic people and one kit to evaluate asymptomatic individuals. Ireland accessed the Panbio test used in the asymptomatic portion of the study under a European Union tender.

The assessment of asymptomatic individuals took place in meat processing plants, which have been the sources of COVID-19 outbreaks around the world. HSE found that using the Abbott test to analyze self-collected nasal swabs detected 41 of the 79 cases picked up by PCR, resulting in a sensitivity of 51.9%. Panbio has a CE mark for asymptomatic screening and self-swabbing.

 

Panbio Coid 19 Test

Panbio Coid 19 Test

Advocates of antigen testing, including Abbott, have argued the approach mainly misses people who have low viral loads and are therefore unlikely to be infectious. In a CDC study, the sensitivity of Abbott’s BinaxNOW antigen test in asymptomatic people rose from 35.8% in the overall population to 78.6% in individuals whose samples could be cultured.

HSE, however, thinks it is important to detect individuals with low viral loads, stating that “people can be seriously ill and can be infectious or be about to become infectious, even when the virus is only detectable at low levels.”

Nonetheless, the health service removed people with low viral loads from the analysis by limiting the dataset to people whose samples yielded positive results after 25 or 30 PCR cycles, also known as threshold cycle (Ct). The analysis did not change HSE’s position.

“Our data indicates that there remains a risk of missing a substantial proportion of potentially infectious cases, including 20% of those with Ct ≤25 and 31% of those with Ct ≤30. Therefore, use of this assay in settings such as testing of asymptomatic high-risk populations is not recommended as a standalone test,” the health service wrote in its report.

The study did not assess the effects of performing frequent repeat testing every two to three days in conjunction with confirmatory PCR. However, with the European Centre for Disease Prevention and Control proposing the approach, HSE said rapid antigen kits could potentially be used in such a testing regimen.

The other part of the study evaluated multiple antigen tests in symptomatic people. With an overall sensitivity of 95%, MyBio’s MoLab mö-screen Corona Antigen Test performed best, although all the results have wide, overlapping confidence intervals that prevent the definitive ranking of the kits.

In general, nasopharyngeal samples resulted in higher sensitivities than nasal swabs.

All the sensitivity results generated by HSE fell short of the manufacturer claimed data but still typically cleared the 80% minimum threshold proposed by the World Health Organization.

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