HOUSTON – A new COVID-19 antibody testing is available in Houston, which has proven to be highly accurate in determining the existence of coronavirus antibodies in a person’s system. Genalyte, a California-based diagnostics company, is offering its SARS-CoV-2 Multi-Antigen Serology Panel at the Toyota Center at 1510 Polk St.
Genalyte will begin accepting appointments on Wednesday. The company has an agreement with the Toyota Center for two weeks with an ability to extend after each two-week period. The intent is to stay in Houston as long as testing is needed, according to the company.
Appointments are available Monday through Friday from 8 a.m. to 5 p.m.
"With COVID-19 cases continuing to rise in Houston, we feel it's imperative to help meet the demand and crucial need for high-quality, extensive antibody testing in the community," said Genalyte CEO Cary Gunn. "Determining a person or a population's level of exposure is not only essential to facilitate research to continue to develop a better understanding of the virus, but also to arm Houstonians with the understanding of current or past exposure to COVID-19. "
Genalyte’s SARS-CoV-2 Multi-Antigen Serology Panel is designed to test for SARS-CoV-2 specific antibodies. The serology test is able to detect the type of antibodies present in a person’s blood. Based on the type of antibodies present, the test may indicate the presence of an active or past infection, according to Genalyte.
Genalyte maintains a College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, which ensures test results meet and exceed industry standards for clinical laboratory testing. The Genalyte SARS-CoV-2 serology panel goes through rigorous validation efforts to ensure clinical effectiveness and is processed on the company’s U.S. Food and Drug Administration (FDA) Cleared Maverick™ Diagnostic System. Genalyte completed the LDT certification for its SARS-CoV-2 Serology Panel and is completely compliant with all regulations. In addition, Genalyte is pursuing an EUA to minimize market confusion although it is not a requirement for a CLIA certified lab under the FDA’s COVID-19 EUA program, according to the company.
Genalyte’s U.S. Food and Drug Administration (FDA)-cleared Maverick™ Diagnostic System will expand antibody testing in the fight against COVID-19 with the launch of its SARS-CoV-2 Multi-Antigen Serology Panel. The antibody test and results represent a crucial step in helping to develop an understanding of the virus, including how long antibodies stay in the body and if they are less susceptible to reinfection.
The Genalyte serology test also has a very low false-positive rate—with accuracy exceeding 99 percent, according to Gunn.
“It’s simple at a high level; we flow your blood through a silicon chip, and so it’s the same type of chip that’s in your cell phone or a computer,” Gunn told KPRC 2. “We flow the blood over the surface of the chip, and we put down chemicals in the chip that will actually pull out the antibodies.”
Genalyte’s antibody testing is only available to those, who are currently not sick and have been symptom-free for two weeks. The appointments must be made online.
Gunn said the test should be free for those who have insurance.
”It shouldn’t cost the patient anything,” Gunn said. “Without insurance, Gunn said the cost for the test will be $149.”
Those looking to get the test must register online, wear a mask, and may park their vehicle outside the Toyota Center’s Bell Street Atrium entrance. Only the person being tested will be allowed inside.
“So what our test does...we actually test for all of the benign coronaviruses that you might have had in the past, and we test for Sars-CoV-2 antibodies,” Gunn said. “In doing so, we’re able to tell you, with very high accuracy, if this is for sure a Sars-CoV-2 infection, if you have antibodies protecting you against that. [As well as] if you have an infection by a regular coronavirus and have some degree of protection or if you have none of those and are actually at high risk.... It’s almost guaranteed at this point. If you’ve developed a robust antibody response, you have a degree of immunity. We don’t know how long it’s going to last yet but you have a degree of immunity to Sars-Cov-2.”
Those interested in being tested for antibodies to the virus can register and book appointments at www.genalytecovid19.com.