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CE
COVID-19 IgM/IgG Ab Test is used for qualitative detection of the IgM and IgG antibodies of COVID-19 in human serum/plasma or whole blood. The COVID-19 IgM/IgG Ab Test is an aid in the diagnosis of patients with suspected COVID-19 infection in conjunction with clinical presentation and the results of other laboratory tests. Instead of waiting for results to return from the lab, clinicians and medical professionals benefit from accurate qualitative results in just 10–15 minutes.
TEST PROCEDURE:
1.Remove the test from the sealed pouch. Lay it on a flat,clean and dry surface.
2.Use the pipette provided to add 1 drop(about 10μL) of specimen to the sample well.
3.Unscrew and remove the top of buffer bottle and hold it vertically, then add 2 drops of buffer(approximate 70μL) to sample well.
4.Read results in 10-15 minutes.
INTERPRETATION OF RESULTS：2.Use the pipette provided to add 1 drop(about 10μL) of specimen to the sample well.
3.Unscrew and remove the top of buffer bottle and hold it vertically, then add 2 drops of buffer(approximate 70μL) to sample well.
4.Read results in 10-15 minutes.
IgG&IgM Positive: Control line and M line &G line appear in the Test Window.
IgMPositive:Two colored lines appear, one is in M area and the other line is in Control area.
IgG Positive:Two colored lines appear, one is in G area and the other line is in Control area.
Negative: Only one line appears in Control area, no line appears in M/G area.
Invalid：No line appears in the Control area, the test results are invalid regardless of the presence or absence of line in the test area. The direction may not been followed correctly or the test may be deteriorated. It is recommended that repeart the test using a new device. If the problem persist, please stop to use the product and contact local distributor.
SPECIFICATION:
| Description | Specimen | Format | Catalog No. | Sensitivity | Package Size | Strip Width | Certificate |
| COVID-19 IgM/IgG Ab Test | Serum/Plasma | Cassette | B290-20 | 93.90% | 25 Tests | 3.0 mm |
CE |
| Whole Blood | B290-21 | 25 Tests | |||||
| B290-22 | 1 Test |
This test has not been authorized for use by the FDA and is not available in the United States.