The MSLRDT100 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma.
It provides an aid in the diagnosis of infection with Novel coronavirus.
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.Six coronavirus species are known to cause human disease. Four viruses-229E, OC43, NL63, and HKU1 are prevalent and typically cause common cold symptoms in immunocompetent individuals. The two other strains severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) are zoonotic in origin and have been linked to sometimes fatal illness.
Coronaviruses are zoonotic, meaning they are transmitted between animals and people. Common signs of infection include respiratory symptoms,fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death.
Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing.
Detection kit for Covid-19
The MSLRDT100IgG/IgM Rapid Test Cassette is a qualitative membrane strip based immunoassay for the detection of antibodies (IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. The test cassette consists of: 1) a burgundy colored conjugate pad containing Novel coronavirus recombinant envelope antigens conjugated with Colloid gold (Novel coronavirus conjugates), 2) a nitrocellulose membrane strip containing two test lines (IgG and IgM lines) and a control line (C line). The IgM line is pre-coated with the Mouse anti-Human IgM antibody, IgG line is coated with Mouse anti-Human IgG antibody. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgM anti-Novel coronavirus, if present in the specimen, will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent pre-coated on the IgM band, forming a burgundy colored IgM line, indicating a Novel coronavirus IgM positive test result. IgG anti-Novel coronavirus if present in the specimen will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent coated on the IgG line, forming a burgundy colored IgG line, indicating a Novel coronavirus IgG positive test result. Absence of any T lines (IgG and IgM) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
[WARNINGS AND PRECAUTIONS]
For healthcare professionals and professionals at point of care sites.
Do not use after the expiration date.
Please read all the information in this leaflet before performing the test.
The test cassette should remain in the sealed pouch until use.
All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
The used test cassette should be discarded according to federal, state and local regulations.
The test contains a membrane strip coated with Mouse anti-Human IgM antibody and Mouse anti-Human IgG antibody on the test line, and a dye pad which contains colloidal gold coupled with Novel coronavirus recombinant antigen.
The quantity of tests was printed on the labeling.
Test cassettePackage insert
Materials Required But Not Provided
Specimen collection containerTimer
The test can be used to test Whole Blood/Serum/Plasma specimens.
To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures.
Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.
Store specimens at 2-8℃ (36-46℉) if not tested immediately. Store specimens at 2-8℃ up to 7 days. The specimens should be frozen at
-20℃ (-4℉) for longer storage. Do not freeze whole blood specimens.
Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.
Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.