INTENDED USE
Novabios Zika Virus IgG/IgM RapiCard InstaTest 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 research use only.
SUMMARY AND EXPLANATION
Novabios 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 reported that Zika virus may cause new born microcephaly and even new born 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.
Novabios Zika Virus IgG/IgM Combo Test is a new generation rapid Immuno-chromatographic test using recombinant Zika viral antigens to detect specific antibody response.
TEST PRINCIPLE
Novabios Zika Virus IgG/IgM Combo Test utilizes the principle of Immuno-chromatography. 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¤CZika 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 indicates a positive test results. 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.
SPECIMEN COLLECTION AND PREPARATION
1.No prior special preparation of the patient is required before sample collection by approved techniques.
2.The test works best on fresh whole blood / serum / plasma samples. If testing cannot be performed immediately, serum /plasma may be stored at 2-8oC up to 3 days in case of delay in testing. For long-term storage, serum / plasma specimens can be frozen at -20oC for 3 months or -70oC for longer period. Blood samples collected with a suitable anticoagulant such as EDTA, Heparin, Oxalate may be stored at 2-8oC up to 3 days. Blood samples should not be frozen.
3.Repeated freezing and thawing of the specimen should be avoided.
4.Do not use hemolyzed, clotted, contaminated, lipamic and viscous/turbid specimen.
5. Specimen containing precipitates or particulate matter must be centrifuged and only the clear supernatant will be used for testing.
6.Do not inactivate the sample by heating.
7.Shipment of specimens should comply with local regulations for transportation of etiologic agents.