Abrishami Dermatopathology: A Pathology and Immunology Reference Laboratory
As a physician led clinical and laboratory practice, our role is to aid patients, physicians, and employers make confident decisions about the next steps that affect the health, safety, and economic prosperity of our community. We understand the challenges facing clinics, hospitals, nursing homes, schools, professional sports and other businesses in our community.
We believe government policies are in their early stage of development and are not tailored for all organizations. The FDA has advocated for EUA testing and Human and Health Services has approved payment for antibody testing.
In summary, we believe viral swab testing and instrumented IgM/IgG Antibody testing, such as the Roche Elecsys anti-SARS-Cov2, are BOTH essential for our community’s fight against Covid-19 and complementary. Because the number of active infections at any one point, i.e. the prevalence, is low, viral swab testing has narrower application. For the vast majority of asymptomatic individuals and for organization aiming to stay vibrant and vigilant, incorporating antibody testing can clarify the next set of decisions. There are many applications for antibody testing depending on institutional needs.
Antibody Testing is powerful tool for detection, in asymptomatic individuals or in suspected infections. We believe it should follow viral swab testing (by 1-2 weeks), improving the detection window and to increase sensitivity and specificity of diagnosis. Antibody testing can provide insight into infection rates and risk within your organization.
Antibody testing can map the immunologic progression of individual to complete recovery and probable immunity. The detection of antibodies by the Roche Elecsys test implies presence of “neutralizing antibodies” that impart immunity. The general scientific consensus is that antibodies impart protective immunity in the exposed, based on experience with Covid-19, Sars, other coronoviruses, and based on studies in primates with Covid-19.
Testing should be always be voluntary and by order of a physician or licensed provider. Employment changes should not be tied in any way to results of antibody testing.
Roche Elecsys® MultiStep ImmunoAssay: IgM and IgG
AUTOMATED & INSTRUMENTED • FDA & EUA AUTHORIZED • 100% SENSITIVITY • 99.8% SPECIFICITY
Introduction: By July 5, 2020, about 320,000 cases of Covid-19 infection and 7000 deaths were confirmed in California by viral detection. 130,000+ of those cases were in Los Angeles County. The actual incidence is certainly higher. Antibody tests randomly performed suggest 5% of the population may have been infected. An estimated 50% of infections are asymptomatic and are the main driver of the pandemic. Infections occur in waves and ~95% have still not been exposed. The disease is highly contagious, unpredictable and can be fatal.
Because the vast majority are still at risk of infection, institutions and businesses will face outbreaks and waves of infection. We believe early testing is a powerful tool for businesses, schools, hospitals and municipalities. It will permit early action to maximize productivity and safeguard health. As part of a comprehensive program, “Antibody testing can play a critical role in the fight against Covid-19” -FDA. Antibody production is an essential function of our immune system and indicates recent or distant exposure to infection. Roche Elecsys detects two classes of antibodies. IgM antibodies rise initially, usually within a week of infection and decline quickly. IgG antibodies rise more slowly and remain elevated.
Highly Accurate Roche Antibody Test to Covid-19 Serves Two Functions:
1- Detection: Clearly, viral swab testing is important for detection in individuals with symptoms or known exposure, during the initial days of infection. But, viral swab test has a narrower window of detection and lower sensitivity. By some estimate, within a week of infection, viral swab sensitivity may drop by about 40%, yielding false negative results.
The detection of recent or distant infection by antibody testing is underutilized. It is complementary to viral swab test, and helpful to identify infected individuals who did not receive a viral swab test in initial days of infection, or may have had a false negative viral swab test. Antibody testing widens the detection window and improves on the detection sensitivity and specificity. It has advantages in asymptomatic individuals and for group testing. It can determine accurate infection rates and exposure risk within one’s institution.
2- Assessment of Immunity: While no guarantee can be made about absolute long-term protection offered by antibodies, it is widely accepted that antibodies are protective when detectable. In fact, administering hyperimmune globulin in ill patients and injecting intramuscular immunoglobulin to individuals at risk of infection are two hopeful ways to battle Covid-19 using antibody technology. On a larger scale, antibody detection can help institutions understand their group immunity to the threat of the pandemic.