While the world waits for a Covid-19 vaccine and coronavirus testing remains a hot topic in many countries battling to get coronavirus under control, it looks like Roche (world’s largest biomedical corporation, headquartered in Switzerland) has the regulatory certification, accuracy, processing speed, test cost and infrastructure to meet global demand. Governments in Europe and North America are moving to use this test as the mainstay of their public health testing, tracking and demographic plotting.

  • Elecsys Anti-SARS-CoV-2 antibody test available in Europe (and elsewhere in the world) with the CE mark issued by the European Union.
  • Elecsys Anti-SARS-CoV-2 antibody test available in the United States with Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA).
  • Elecsys Anti-SARS-CoV-2 produced by Roche with global capacity delivered tests in “high double digit millions per month” serving healthcare systems in Europe2 and North America1.
  • As of 24 April 2020, no study has tested whether antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans4.

NOTE: for countries with specific regulatory requirements, local approval timelines apply. There may be other country-specific regulations, such as import requirements, which will determine when the test becomes available locally.

There’s no reason governments should withhold coronavirus testing from the public, except where the Govt has decided to spend less and let infections and fatalities be higher.


BACKGROUND

Elecsys Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma.

Elecsys Anti-SARS-CoV-2 serology test is a blood sample. Based on in-solution double-antigen sandwich format. Blood samples taken 14 days after PCR-confirmed infection process Elecsys Anti-SARS-CoV-2 test with 100% accuracy.

Elecsys Anti-SARS-CoV-2 assay has 99.81% specificity3 and shows no cross-reactivity to the four human coronaviruses causing common cold. Detection of other coronaviruses (non-SARS-CoV-2) detected antibodies at 100% sensitivity.

European CE mark and US FDA EUA (Emergency Use) certification extant for Elecsys Anti-SARS-CoV-2 serology test.


PRICE AND AVAILABILITY

  • Hospitals and reference laboratories can run the Elecsys Anti-SARS-CoV-2 on the Roche Cobas E411 Analyser.
  • Unit price average $24,500 for 86 tests per hour standard single model.
  • Result (per test) takes approximately 18 minutes start to finish. Higher model Analysers (at greater unit cost) can increase tests per hour throughput to up to 300 per hour.
  • All the Roche Analysers are compatible with the coronavirus Elecsys Anti-SARS-CoV-2 test.
  • Elecsys Anti-SARS-CoV-2 antigen test available worldwide, with Roche producing up to one billion tests annually.
  • Roche Analysers available in North America, Europe, Japan, China, Asia-Pacific, Australia, New Zealand and other territories.

REFERENCES

[1] The Emergency Use Authorisation (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of medical countermeasures needed during public health emergencies https://www.fda.gov/home

[2] CE-IVD marking is granted  through completion of a comprehensive technical validation and self declaration under the European Directive for In Vitro Diagnostic Medical Devices.

[3] Full specifications of Roche’s Elecsys Anti-SARS-CoV-2 antibody test and immunoassay systems, including throughput, available via Roche website (or local partner/distributor).

[4] https://www.who.int/news-room/commentaries/detail/immunity-passports-in-the-context-of-covid-19

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