***Caution: This product is not 510(k) cleared by US FDA and thus is not for sale in the United States.***
LumiQuick Webpage: lumiquick.com
Instructions for Use: lumiquick.cld.bz/IFU-Zika
Brochure: lumiquick.cld.bz/Flyer-Zika
Product Listing: lumiquick.cld.bz/Brochure-Main
LumiQuick's Document Server: lumiquick.cld.bz
INTENDED USE
QuickProfile™ Zika Virus IgG/IgM Combo Test is a rapid immunochromatographic assay for the simultaneous detection of IgG and IgM antibodies to Zika virus in human whole blood, serum or plasma. The assay is intended for diagnostic use only.
INTRODUCTION
Zika virus is a mosquito-transmitted flavivirus closely related to dengue virus, first isolated in the Zika Forest of Uganda in 1947. The virus is commonly found in Africa but has spread to Asia, South Pacific Islands and Latin America. It has been reported that Zika virus may cause new born microcephaly and even newborn fatality. Clinical symptoms of Zika virus infection include fever, conjunctivitis, transient arthritis/arthralgia and maculopapular rash that often starts on the face and then spreads thorough out the body. There is no specific therapy for Zika virus infection. Patients are treated with pain relief medicine or anti-inflammatory medication if dengue infection can be ruled out.
QuickProfileTM Zika Virus IgG/IgM Combo Test is a new generation rapid immunochromatographic test using recombinant Zika viral antigens to detect specific antibody response.
TEST PRINCIPLE
QuickProfile™ Zika Virus IgG/IgM Combo Test utilizes the principle of Immunochromatography. Mouse anti-human IgM and human IgG antibodies are immobilized on the nitrocellulose membrane respectively, as two individual test lines (IgM line and IgG line) in the test window of the test device. The IgG line in the test window is closer to the sample well and followed by IgM line. As the test sample flows through the membrane within the test device, the colored-Zika NS1 specific recombinant antigen-colloidal gold conjugate complexes with specific antibodies (IgM and/or IgG) of Zika virus, if present in the sample. This complex moves further on the membrane to the test region where it is captured by the anti-human IgM and/or human IgG antibodies coated on the membrane leading to formation of a colored band, which indicates a positive test result. Absence of this colored band in the testwindow indicates a negative test result. A built-in control line will always appear in the test window when the test has performed properly, regardless of the presence or absence of anti-Zika virus antibodies in the specimen.