QuikPac II™ Coronavirus (COVID-19) IgG & IgM Rapid Test
Minimum Order Qty – 100,000 Tests
Payment Terms: 50% down payment will be required same day U.S. manufacturer approves purchase order. The remaining balance plus Shipping and any applicable taxes will be due upon completion of order. Wire ACH Bank Instructions will be sent when P.O. is accepted. Payments will be made directly to U.S. manufacturer.
The QuikPac II™ 2019 Coronavirus IgM and IgG Test provides an excellent methodology for specifically detecting anti-SARS-CoV-2 IgG and IgM antibodies. The presence of high titers of IgG antibodies does not interfere with the detection of IgM antibodies in the sample.
By using a mixture of recombinant Nucleocapsid protein, the test is able to detect SARS-CoV-2 infection. PRINCIPLE OF THE TEST Serum, plasma or whole blood samples may be used with this test. When a specimen is added to the test, anti-CoV IgG and IgM in the specimen sample react with recombinant coronavirus nucleocapsid proteins of colloidal gold conjugates and form a complex of antibodies and colloidal gold conjugates. As this mixture moves along the length of the teat strip by capillary action, the anti-coronavirus IgG or IgM complex is captured by the corresponding anti-human IgG and/or IgM immobilized in two lines across the test strip and generates a colored line. The appearance of a Pink color in a specific test region (IgG or IgM) should be considered as positive for that particular antibody type (IgG or IgM). A Red procedural control line should always develop on the test strip to indicate that the test has been performed properly. MATERIALS PROVIDED Each kit contains the following components in sufficient quantities to perform the number of tests indicated on the package label: 25 Test Kit • 25 test packs individually foil pouch with a desiccant. Each strip contains two (2) test lines: one that captures human IgG antibodies and another that captures IgM antibodies. The strip also contains a third procedural control line. • 1 Product Instruction Sheet • 1 Dropper bottle of buffer reagent • 25 x 15 microliter Capillary transfer tube (Optional Component) • 25 Lancets
Background: Coronavirus (CoV) belongs to the Coronaviridae family and is divided into three types: α, β and γ. Alpha and beta are only pathogenic to mammals and gamma mainly causes bird infections. CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through the fecal-oral route as well. So far there are seven types of human coronavirus (HCoV) that cause human respiratory diseases: HCoV-229E, HCoV-NL63, HCoV-OC43, HCoV-HKU1, SARS-CoV, MERS-CoV and the novel coronavirus (2019). The novel coronavirus (2019) was discovered in 2019 in Wuhan, China with viral pneumonia cases and clinical manifestations were fever, fatigue, cough, and other symptoms which can rapidly develop into severe pneumonia, respiratory failure, septic shock, multiple organ failure, severe acid-base metabolism disorders, etc. and is life threatening. Human coronaviruses primarily replicate in the respiratory tract and cause infections ranging from common colds to severe acute respiratory syndrome (SARS). Coronaviruses are single-stranded RNA viruses with outer envelopes that have distinct crown-like morphologies. Patients with SARS-CoV-2 infection often exhibit symptoms of viral pneumonia, including fever, cough, runny nose, shortness of breath, bilateral lung infiltration and respiratory failure in the most severe cases. Currently, there is no specific treatment or available vaccine that protects against SARS-CoV-2 infection. Spike (S) protein, nucleocapsid (N) protein, membrane (M) protein, and the envelope (E) protein are the four major structural proteins of SARS-CoV-2. Amongst them, the S-protein supports strong interaction with human cell receptors, indicating the greatest potential as an effective target for the development of neutralizing antibodies and antiviral drugs. The general immune response to this virus includes the production of IgM antibodies by the 5th day of symptoms which remain in the circulatory system for 30-60 days. IgG antibodies appear by the 14th day of infection and may persist for life. A secondary infection also induces an IgM antibody response after 20 days of infection and IgG antibodies rise within 1-2 days after the onset of symptoms. Therefore, patients with secondary infections will have a positive IgG result, usually along with a positive IgM result. Thus, the use of a reliable and sensitive rapid serological test that can simultaneously detect the presence of anti-coronavirus IgG and IgM antibodies is of great clinical utility.
QuikPac II™ Coronavirus (COVID-19) IgG & IgM Test Catalog No. 29000
NOTE: Updated USFDA guidance issued on March 16, 2020, allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care.