COVID-19 Rapid Test Kit IgG/IgM (10 min) Antibody Test
COVID-19 Coronavirus IgG/IgM Rapid Test Kit Authorized and Affiliated with Rinnovare HomeDialysis, LLC
(For Medical Professional Use Only)
Rapid results within 10 minutes invalid after 15 minutes.
Small sample size
Shelf life of up to 24 months from manufacture date
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
Following the incubation period, IgM may appear in blood within 3-5 days. IgG will appear as soon as 1-2 weeks.
Sample: Test can work with whole blood, plasma and serum samples.
Storage: The kit can be stored at room temperature or refrigerated (2-30°C).
Shelf Life: Up to 24 months from manufacture date
More information, such as the product insert, clinical trial results, and CE documentation is available at request
COVID-19 IgG/IgM Rapid Test Cassette Instructions for Use:
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test device on a clean and level surface.
3. (For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
(For Serum or Plasma Specimens): With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
4. Wait for the colored line(s) to appear. After 2 minutes, if the red color has not moved across the test window or if blood is still present in the specimen well (S), add 1 additional drop of the sample buffer to the buffer well (B).
5. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.
The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.
The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.
The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies
IgG and IgM Positive:
The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.
Control line is partially red, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.