COVID-19 IgG/IgM Rapid Test Cassette （Whole Blood/Serum/Plasma） is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma.
This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette （Whole Blood/Serum/Plasma） must be confirmed with alternative testing method（s） and clinical findings.The COVID-19 IgG/IgM Rapid Test Cassette （Whole Blood/Serum/Plasma） is alateral flow immunochromatographic assay. The test uses anti-human IgM anti （test line IgM） , anti-human IgG （test line IgG） and rabbit IgG （control line C） immobilised on a nitrocellulose strip.
The burgundy colored conjugate pad contains colloidal gold conjugated to recombinant COVID-19 antigens conjugated with colloid gold （COVID-19 conjugates）. When a specimen followed by assay buffer is added to the sample well, IgM &/or IgG antibodies if present, will bind to COVID-19 conjugates making antigen antibodies complex. This complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line of the corresponding immobilized anti （anti-human IgM &/or anit-human IgG） the complex is trapped forming a burgundy colored band which confirm a reactive test result. Absence of a colored band in the test region indicates a non reactive test result.
To serve as a procedural control, a colored line will always change fromblue to red in the control line region, indicating that the proper volume of pecimen has been added and membrane wicking has occurred.
1. For professional In Vitro diagnostic use only and not for home use. Do not use after expiration date.
2. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
3. Do not use it if the tube/pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any circumstances.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Humidity and temperature can adversely affect results.
8. Do not perform the test in a room with strong air flow, ie. electric fan or strong air-conditioning.
*To be administered by medical professionals only