This kit is a qualitative test for the detection of IgG and IgM antibodies to COVID-19 in human serum, plasma or whole blood. The test provides a dierential detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2-IgG antibodies and can be used for the presumptive distinction between a primary and secondary Coronavirus infection. This test is for in-vitro diagnostic use only.
New rapid test that provides accurate COVID-19 infection diagnosis in 15 minutes. It is widely accepted that IgM provides the first line of defense during viral infections, followed by the generation of adaptive, high affinity IgG responses for long term immunity and immunological memory. Testing of COVID-19 IgM and IgG antibodies is an effective method for the rapid diagnosis of COVID-19 infection. Detection of COVID-19 IgM antibodies to indicate a recent exposure to COVID-19, whereas detection of COVID-19 IgG antibodies indicates a later stage of infection. Thus, this combined antibody test could also provide information on the stage of infection.
Rapid Screening of Symptomatic and Asymptomatic Carriers.
This assay can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic. Recent studies suggest that a high percentage of patients show no clinical symptoms of the virus, thus screening patients is vitally important. The test is ideally suited for hospitals, clinics and test laboratories. The test can also be effectively deployed in businesses, schools, airports, seaports and train stations, etc., giving it the potential to become a compelling force in the ﬁght against this global threat.
Comparison With PCR Nucleic Acid Tests
The test was validated using 310 clinically positive and negative patient samples. The overall test sensitivity in serum/plasma of IBL Covid-19 IgG/IgM is 97.2% and specificity is 99.2%. The overall test sensitivity in whole blod of IBL Covid-19 IgG/IgM is 97.2% and specificity is 98.8%.• For Rx use only. • This test has not been reviewed by the FDA. For use in clinical laboratories by health care professionals following FDA guidance “Policy for Diagnostic Tests for Coronavirus Disease-2019 (COVID-19) during the Public Health Emergency”. • 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 assay 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. • Not for the screening of donated blood.
Disposable Virus Sampling Kit
Used for collection, transportation and storage of the specimens (virus). The test principle for this product mixes the collected specimen with Virus Transport Media A/ Virus Transport Media B. Virus Transport Media A keeps the morphological structure of virus; Virus Transport Media B inactivates the virus while effectively ensure the stability of the viral nucleic acid during in-vitro storage and transportation. The main composition consists of a sampling swab and / or cell preservation solution (non-inactivated / inactivated type).
Freshly collected specimens can be delivered to the laboratory at room temperature (5-25 ° C). Using ice packs are better for transportation. Specimens used for nucleic acid testing should be tested as soon as possible. Specimens tested within 48 hours should be stored at 2-8 ° C; specimens that cannot be tested within 48 hours should be stored at or below -70 ° C, and guaranteed to be shipped to the corresponding laboratory for testing. The specimen should avoid repeated freezing and thawing.
Used for sample collection, transportation and storage. The use of disposable virus sampling tubes should be professional medical personnel or laboratory personnel. This product is a single-use virus sampling tube for new coronavirus, influenza virus (general influenza, high pathogenicity, avian influenza, H1N1 influenza virus, etc.), SARS, hand, foot, mouth, respiratory tract and intestinal tract virus sampling and delivery. It is suitable for disease control departments and clinical medical departments to use for sampling of infectious pathogen microorganisms. It is used to transport the nasopharyngeal swabs, oral swab specimens or tissue specimens from the sampling site to the testing laboratory for PCR extraction and testing.
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