Lab Testing Temporary
20/20 expects to soon offer Roche Diagnostics’ new and highly accurate COVID‑19 antibody serology which received Emergency Use Authorization from the FDA on May 2, 2020.
The Roche Elecsys® Anti‑SARS‑CoV‑2 is an immunoassay intended for qualitative detection of antibodies to SARS‑CoV‑2 in human serum and plasma (K2‑EDTA, K3‑EDTA, Li‑heparin). The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection.
Serological assays can contribute to the identification of individuals exposed to the virus and assess the extent of exposure of a population, and might thereby help to decide on application, enforcement or relaxation of containment measures.
Graphic adapted from Roche Diagnostics
Healthcare provider fact sheet
Patient Fact Sheet
Roche Covid-19 FAQ’s
FDA Emergency Use Authorization (EUA)
CONENT BELOW IS FROM CONTENT in SharePoint file
KEY FEATURES & BENEFITS (use icons)
· Qualitative detection of IgM and IgG antibodies that bind to the virus that causes COVID-19
· Market-leading accuracy
· Manufactured by world’s largest IVD immunoassay company headquartered in Europe[DS1] .
· 100% sensitivity
· Lower Laboratory fees then most PCR tests
· Assay is authorized by USFDA For emergency use.
· Instrument system is used in other assays that are FDA approved
· Testing is performed in a CLIA certified lab
Manufacturer’s Test Performance Features:
SENTISTIVITY AND SPECIFICITY:
1. Sensitivity of 100% (for samples taken from patients at least 14 days after PCR confirmation of infection) and an overall specificity of 99.81% (over 5,000 samples tested)
No identified cross reactivity with samples containing antibodies to HIV, four other common cold coronaviruses, other pathogens, nor to 40 common cold samples.
1) Order kits on our website
2) Collect patient serum sample and mail to 20/20’s CLIA Lab.
3) Results reported within X days [DS2] of arrival.
Information about the Anti-SARS-CoV-2 Assay
· Serum and Plasma (heparin or EDTA) specimens only
· Prescription use only
· Assay detects antibodies indicating an adaptive immune response has occurred because of a current or prior infection
· Not to be used to diagnose or exclude acute infection.
· Not to be used as the sole basis for treatment or patient management decisions.
· Direct viral testing should be performed if acute infection is suspected.
· Specimens should be collected with appropriate infection control precautions following CDC Interim Infection and Control Recommendations for Patients with Confirmed Coroanvirus Diesease 2019 (COVID-19) or Persons Under Investigation for COVID-19 in Healthcare Settings
· Use appropriate personal protective equipment when collecting and handling specimens
· Patients with detected antibodies may still be infectious.
· The typical duration of an antibody response to SARS-CoV-2 is unknown and inter-individual differences may be significant.
· It is unknown if an antibody response confers complete or partial immunity to infection.
· Laboratory tests results should always be considered in the context of clinical observations and epidemiological data.
· False positive and false negative results are possible (as with any test).
· FDA has authorized use of this test for up to the duration of the declaration by the Secretary of Health and Human Services of a public health emergency.
[DS1]This is optional marketing point. Please feel 100% free to delete if undesirable.
[DS2]DO NOT Publish with an “
X” in the text
Information about FDA oversight of serology tests for SARS-CoV-2
Further Information is available at:
· Important Information on the Use of Serological (Antibody) Tests for COVID-19 – Letter to Health Care Providers;
· FDA Fact Sheet – Serological Testing for Antibodies to SARS-CoV-2 Infection; and
· Serology/Antibody Test FAQs in the FAQs on Diagnostic Testing for SARS-CoV-2.