Covid-19 Rapid results testing kits (Coronavirus)

We now offer Rapid Covid-19 testing kits for the following industries:

• Medical professionals
• Medical organization
• Nursing care facility
• U.S. Government
• Private Medical practice
• And other medical-related professionals

The Covid-19 IgG/IgM Rapid results test is a 10 minute instant point of care test device for the qualitative detection of IgG and IgM antibodies specific to  Covid-19 in human whole blood serum or plasma specimens. 

COVID-19 IgG/IgM Rapid Test
(Whole Blood / Serum / Plasma)

INSTRUCTIONS FOR USE
The COVID-19 IgG/IgM Rapid Test is a 10 minute instant point-of-care test device for the qualitative detection of IgG and IgM antibodies specific to COVID-19 in human whole blood, serum or plasma specimens. IMPORTANT On March 16, 2020 the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. The updates include guidance that allows for serological test that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 from clinical specimens, like Biolab Sciences COVID-19 IgG/IgM Rapid Test, to be used in laboratories or by healthcare workers.
Please note the following information: ● This test has not been reviewed by FDA ● Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. ● Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. ● Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. ● This test is not for the screening of donated blood ● This test is for professional use.

INTENDED USE
The COVID-19 IgG/IgM Rapid Test Cassette is intended to be used in conjunction with other test and/or clinical and epidemiological information:
● For the in vitro qualitative detection of IgM and IgG antibodies specific to 2019n-CoV (detected in China in 2019) in whole blood / serum / plasma collected directly from symptomatic patients. The test may cross react with other viruses not tested for.
● For the presumptive identification of viral infections in patients who may be infected with 2019nCoV (detected in China in 2019) in conjunction with clinical and epidemiological risk factors. The test may cross react with other viruses not tested for.
● To provide epidemiologic information for surveillance of 2019n-CoV.

Testing with the COVID-19 IgG/IgM Rapid Test should only be performed in conjunction with other laboratory approved testing and/or clinical observations for the presumptive identification of viral infections in patients who may be infected with 2019n-CoV.
All test results are presumptive and should be confirmed by an approved molecular assay. A presumptive negative test does not preclude 2019n-CoV infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, a presumptive positive result does not rule out infections caused by other viruses.

SUMMARY AND EXPLANATION

Early January 2020, a novel coronavirus (COVID-19) was identified as the infectious agent causing an outbreak of viral pneumonia in China, where the first cases had their symptom onset in December 2019.1 Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds that cause respiratory, enteric, hepatic, and neurologic diseases.2 Six coronavirus species are known to cause human disease.3 Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals.3 The two other strains — severe acute respiratory syndrome coronavirus (SARS-COV) and Middle East respiratory syndrome coronavirus (MERS-COV) — are zoonotic in origin and have been linked to sometimes fatal illness.4 Coronaviruses are zoonotic, which means they can be transmitted between animals and people. Common signs of infection include respiratory symptoms, fever, and cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death.5 Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose when coughing and sneezing, and thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing. 5 EXPLANATION In response to the global pandemic caused by 2019n-CoV, Biolab’s COVID-19 IgG/IgM Rapid Test was developed as a 10 minute simple point-of-care test using a lateral flow immunoassay that will allow medical 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.

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We appreciate your patience as these kits are in high demand, contact us at info@globalidentityscreeners.com or via phone at 888-284-8024 for more information regarding pricing and availability.