PARIS – Abbott Laboratories is launching distribution of its latest Panbio COVID-19 Rapid Test in France.

“This rapid and portable nasopharyngeal swab test device is a very useful tool for supporting public health strategies in France, such as contact case tracing and large-scale testing campaigns across France,” Jean-Baptise Nivet, Abbott France Sales Director, told BioWorld.

French labs flooded with a million tests each week

The number of patients infected with COVID-19 is growing exponentially in the general population in France. According to Martin Hirsch, director of the Assistance Publique-Hôpitaux de Paris (AP-HP), with 39 hospitals and eight million patients treated each year, “the number of patients hospitalized at our facilities is doubling every three weeks.”

Moving forward, one million RT-PCR tests will be carried out each week at 5,649 sampling centers in France. However, departments at the Ministry of Health accept that: “significant tensions exist, with difficulty getting tested, sometimes with long delays in accessing the test and obtaining the results.”

Since the beginning of September, the French have waited in endless queues outside laboratories in the major cities. Faced with the total saturation of laboratories, the French public authorities are seeking to broaden the range of tests in order to identify quickly those who have been infected in airports or hospital reception areas.

While the standard PCR test requires intense laboratory analysis to detect the genetic material of the coronavirus, the antigen test detects the presence of the virus or just fragments of the SARS-CoV-2 virus. “These tests, designed to be simple, portable and easy to use, have the advantage of spotting virus proteins quickly,” said Nivet.

Following the U.S., France to scale up COVID-19 antigen testing

The Panbio COVID-19 Ag Rapid Test is Abbott’s sixth test for COVID-19. Three are molecular and detect the virus during active infection; two are serology tests identifying IgG antibodies, proteins the body produces in the later stages; and one is an antigen test that identifies COVID-19 mid-infection, as the virus multiplies. Abbott’s range includes its m2000 and Alinity m high-volume molecular biology systems and high throughput Architect and Alinity I laboratory instruments. Months ago, its Binaxnow obtained FDA clearance for emergency use by authorized U.S. laboratories. This rapid antigen test, the size of a credit card and using lateral flow technology, costing just $5 per test, requires no equipment and delivers results in 15 minutes.

On Aug. 27, U.S. President Donald Trump reported the purchase of 150 million of these rapid Abbott tests, at a total cost of $750 million. “We’ve scaled up complex manufacturing equipment, processes, and facilities to produce millions of tests in a month, something that normally would take a year or more,” said Robert Ford, president and CEO of Abbott Laboratories. Abbott Park, Ill.-based Abbott is producing tens of millions of tests this month, and will be producing 50 million tests a month in October and beyond.

Abbott’s latest Panbio COVID-19 Ag test obtained CE marking approval in early September. It is an immunochromatographic test for rapid qualitative detection of the SARS-CoV-2 virus. A nasopharyngeal swab is used to collect samples from people who meet the clinical and/or epidemiological criteria for COVID-19.

The test delivers a response within 15 to 20 minutes. Preliminary results from a clinical study conducted by Abbott on 241 samples demonstrated that the Panbio COVID-19 Ag test has a sensitivity of 93.3% and a specificity of 99.4%, in people suspected of having been exposed to COVID-19 or showing symptoms in the past seven days. Abbott has submitted information regarding this test to the World Health Organization, for inclusion in the Emergency Use Listing.

“This solution is ideally suited to be deployed at the point of care, in a variety of settings as close as possible to patients. This accessible and affordable test opens up the possibility of large-scale testing,” said Nivet.

Abbott's initiative is timely in France. Not one of the 198 COVID-19 tests listed and authorized by the French public authorities is a rapid antigen test. Over the last two months, rapid COVID-19 antigen tests have started being trialed in hospitals in Paris, in order to relieve private laboratories. Recently, the Saint-Louis Hospital in Paris and the Henri Mondor University Hospital in Créteil have been conducting an evaluation study on seven hundred samples, half positive and half negative, of two antigen tests available this summer: one from Belgian firm Coris Bioconcept SPRL and one from the South Korean firm SD Biosensor Inc.

Results showed that the Biosensor test, which has a CE mark, is effective according to the definition from the World Health Organization (WHO). The AP-HP has ordered 100,000 Biosensor tests on the back of this, which have just been delivered. A week ago, the group of hospitals in Ile-de-France began assessing the feasibility of these tests in real conditions in a clinical trial protocol described as “systematic double” on a cohort of eight hundred subjects. The samples from these people are systematically tested using both methods, PCR and rapid.

Ready for large-scale use in France

The Minister of Health, Olivier Veran, has just announced: “we expect to start using antigen tests in the Paris region this week.” The goal is to roll out rapid antigen testing on a wider scale beginning Sept. 20.

Abbott intends to build up screening capacity in France, particularly at the level of medical centers, mobile screening centers and airports. A ministerial decree was published on Sept. 16 authorizing large-scale use of these antigen tests, in addition to the current arrangements set up by medical biology laboratories throughout France. It opens up the market in France to manufacturers of rapid antigen tests for detecting COVID-19 in the population.

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