Lenco Diagnostic Laboratories (Lenco), one of NYC's largest privately-owned full service reference laboratories, provides an update on COVID-19 testing and recently launched IgG and IgM serology testing to detect antibodies against COVID-19.
In mid-March, Lenco became one of the first 28 approved New York laboratories to start testing for COVID-19 with a molecular based assay utilizing PCR technology for the qualitative detection of nucleic acid in respiratory specimens in patients who meet the Centers for Disease Control and Prevention criteria.
"To date, we have successfully processed roughly 17,000 tests," said Dennis Tilman, Chief Operating Officer of Lenco. "Approximately 50% of those tested, were positive for COVID-19. We are extremely thankful to our manufacturing partners who helped us become one of the first laboratories in NYC to launch a COVID-19 test and serve our community that is currently in crisis."
In addition to COVID-19 testing, Lenco also recently launched IgG and IgM serology testing aimed to detect antibodies against COVID-19. Antibody testing is performed using blood specimens collected from individuals who may have been infected with COVID-19. While IgM antibodies are the initial immune response detectable in the blood within 3-5 days after symptom onset, IgG antibodies appear in the blood within 3-4 weeks after the initial infection.
The COVID-19 IgG/IgM test is manufactured by San Diego based Diazyme, which has validated the test's performance. While the test has not yet received FDA EUA authorization, Diazyme is distributing the test and Lenco is performing the test under the recently revised FDA policy outlined in Section IV.A of the Policy for Diagnostic Tests for Coronavirus Disease-2019 (Updated 4/20). As noted on the FDA website, Lenco is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. Lenco has completed the verification of the performance of the test and has notified the FDA that it has begun testing.
When clinically indicated, serological testing may help physicians determine whether patients were recently infected or exposed to the COVID-19 infection in the past, and may determine an overall immune response to the virus. Furthermore, the tests will be extremely helpful in potentially additional treatment for critically ill patients using the FDA's recently allowed "emergency use" of COVID-19 convalescent plasma. Plasma will be obtained from recovered individuals and separated from red blood cells. Plasma containing antibodies needed to fight the virus will then be transfused to the critically ill patients and red blood cells will be returned to the donors.
"On April 16th, the first day our test went live, we ran 584 tests," said Robert Boorstein, MD, PhD, Lenco's Medical Director. "With a capacity of running 2000 tests a day, we presume the numbers will scale up in the coming weeks as more testing is requested. We are also working on producing a quantitative test that will be used to determine the amount of antibodies present in blood. Serving some of the largest institutions and hospitals in New York City such as Maimonides Medical Center, Care for the Homeless, SUNY Downstate and other critical health centers, we will continue to work around the clock prioritizing COVID-19 PCR and COVID-19 antibody testing for New York's sickest and most vulnerable patients."
Important Links and Updates about COVID-19
Lenco is a full-service clinical reference laboratory offering clinical diagnostics at its best. The laboratory is renowned for excellence and expertise with Lenco’s highly dedicated team of specialists in the field who possess experience, professionalism and dedication. Lenco continuously meets the needs of their physician clients and their patients and is committed to being one of the top leading laboratories in a world of rapidly advancing diagnostic technology. To learn more about Lenco, visit www.lencolab.com.