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* These kits are for in vitro diagnostic use and have been submitted for Emergency Use Authorization following guidance from the FDA on March 16, 2020. The tests have not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.
In response to the global pandemic caused by 2019n-CoV, the COVID19 IgG/IgM Rapid Test Cassette was developed as a 10 minutes simple field test using a lateral flow immunoassay that will allow field personnel with minimal training to perform. The test detects the presence of IgG and IgM antibodies specific to 2019n-CoV (detected in China in 2019) generally available in whole blood / serum / plasma after infection by 2019n-CoV.
The test has been widely used in Europe and currently in New York. LEAA is now able to provide this test as a point of care or telehealth Covid-19 testing solution.
How the test works During testing, when the specimen is added to the test cassette, it reacts with 2019-nCoV antigen-coated particles inside the test cassette.
The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG coated in the IgG test line region. If the specimen contains IgG antibodies to 2019-nCoV, a complex will be formed resulting in a colored line that will appear in the IgG test line region.
Similarly, anti-human IgM is coated in the IgM test line region and if the specimen contains IgM antibodies to 2019-nCoV, the conjugate-specimen complex reacts with anti-human IgM on the membrane. A colored line appears in IgM test line region as a result.Clinical PerformanceThe clinical performance of the “COVID19 IgG/IgM Rapid Test Cassette” was evaluated in Shanghai, China with clinical samples derived from blood samples collected from 2019n-CoV infectious patients and 2019n-CoV non-infectious patients confirmed by PCR.
The study included testing of 20 known positive samples and 50 known negative samples.Of the 20 known positive samples, the IgG test yields a 100% agreement of 20 out of 20, while the IgM test yields an 85% agreement of 17 out of 20.Of the 50 known negative samples, the IgG test yields a 98% agreement of 49 out of 50, while the IgM test yields a 96% agreement of 48 out of 50.IgG.
• IgG test results yields 20 positive results from 20 know positive samples.
• IgG test results yields 49 negative samples from 50 known negative samples.
• Relative Sensitivity: 100%
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