"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. "On April 16 th, the first day our test went live, we ran 584 tests," said Robert Boorstein, MD, PhD, Lenco's Medical Director. 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. Plasma will be obtained from recovered individuals and separated from red blood cells. 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. 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.
#LENCO DIAGNOSTIC LABORATORY VERIFICATION#
Lenco has completed the verification of the performance of the test and has notified the FDA that it has begun testing. As noted on the FDA website, Lenco is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 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). The COVID-19 IgG/IgM test is manufactured by San Diego based Diazyme, which has validated the test's performance. 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. Antibody testing is performed using blood specimens collected from individuals who may have been infected with COVID-19. In addition to COVID-19 testing, Lenco also recently launched IgG and IgM serology testing aimed to detect antibodies against 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." "Approximately 50% of those tested, were positive for COVID-19. "To date, we have successfully processed roughly 17,000 tests," said Dennis Tilman, Chief Operating Officer of Lenco. 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.
#LENCO DIAGNOSTIC LABORATORY UPDATE#
BROOKLYN, N.Y., Ap/PRNewswire/ - 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.
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