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INTENDED USE

The COVID-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti–COVID-19 virus and IgM anti-COVID-19 virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with COVID-19 viruses. Any reactive specimen with the COVID-19 IgG/IgM Rapid Test must be confirmed with alternative testing method(s).

PRINCIPLE

The COVID-19 IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of COVID-19 antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the Test region, anti-human IgM and IgG is coated. During testing, the specimen reacts with COVID-19 antigen-coated particles inthe test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the antihuman IgM or IgG in test line region. If the specimen contains IgM or IgG antibodies to COVID-19, a colored line will appear in test line region.Therefore, if the specimen contains COVID-19 IgM antibodies, a colored line will appear in test line region M. If the specimen contains COVID-19 IgG antibodies, a colored line will appear in test line regionG. If the specimen does not contain COVID-19 antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appeared in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

PRODUCT SPECIFICATION

ASSAY PROCEDURE

Bring the specimen and test components to room temperature Mix the specimen well prior to assay once thawed.Place the test device on a clean, flat surface.
For capillary whole bloodsample:
To use a capillary tube: Fill the capillary tube and transfer approximately 10 µL (or 1 drop) of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 1 drop (about 30µL) of Sample Diluentimmediatelyinto the sample well.
For whole blood sample:
Fill the dropper with the specimen then transfer 1 drop (about 10 µL) of specimen into the sample well. Making sure that there are no air bubbles.Then transfer1drop(about 30µL)of Sample Diluentimmediately into the sample well.
For Plasma/ Serum sample:
Fill the dropper with the specimen then transfer 10 µL of specimen into the sample well. Making sure that there are no air bubbles. Then transfer1 drop (about 30 µL)of Sample Diluent immediately into the sample well.
Set up a timer.Read the result at 15 minutes. Don’t read result after 30minutes. To avoid confusion, discard the test device after interpreting the result.

WARNINGS AND PRECAUTIONS

For professional in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• 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.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are
being tested.
• Humidity and temperature can adversely affect results.