Intended Use
The Measles IgG/IgM Rapid Test is a rapid,serological,lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM and IgG antibodies to measles in human whole blood,serum or plasma specimens.It is intended to be used by healthcare professionals as a screening test and as an aid in the diagnosis of infection with measles.The test only provides preliminary analysis results but not critical diagnosis criteria.Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s)and clinical findings based on professional judgment of healthcare providers.
Principle
The Measles IgG/IgM Rapid Test is a qualitative membrane-based immunoassay for the detection of IgM and IgG antibodies to measles in human whole blood,serum or plasma specimens.The test consists of:1)a purple colored conjugate containing recombinant Measles virus antigens conjugated with colloid gold(Measles virus conjugates)and IgG-gold conjugates,2)a nitrocellulose membrane strip containing two test lines(“G”and“M”)and a control line(C).The test line“G”is pre-coated with monoclonal anti-human IgGfor detection of anti-Measles virus IgG.The test line“M”is pre-coated with monoclonal anti-human IgM for detection of anti-Measles virus IgM.When an adequate volume of test specimen is applied into the sample pad of the test,the specimen migrates by capillary action across the strip.Anti-Measles virus IgG and/or anti-Measles virus IgM if present in the specimen will bind to the Measles virus conjugates.The immunocomplexis then captured on the membrane by the pre-coated anti-human IgG and/or anti-human IgM antibodies,forming a purple colored test line(s)(“G”and/or“M”),indicating an anti-Measles virus IgG and/or anti-Measles virus IgM positive test result.Absence of test line suggests anegative result.
An internal quality control is included in the test,in the form of a colored line appearing in the control line region(C),indicating that the test is functional,and proper and sufficient volume of specimen has been applied to enable migration through the test and control line,regardless of whether there is a test line or not.If the control line(C)does not appear within the testing time,test result is invalid and the test shouldbe repeated with a new test device.
