COVID-19 /SARS-CoV-2 IgG/IgM Rapid Test
INTENDED USE
The SARS-CoV-2 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow immunoassay for the qualitative detection and differentiation of IgG and IgM of Novel Coronavirus (SARS-CoV-2) in human wholeblood,serum or plasma.
This test is intended to be used as an aid in the diagnosis of infection with Novel Coronavirus. Any reactive specimen with the SARS-CoV-2 IgG/IgM Rapid Test must be confirmed with alternative testing method(s).
MATERIALS
ASSAY PROCEDURE
- Bring the specimen and test components to room temperature if refrigerated or frozen. Place the test device on a clean, flat surface and label specimen number.
- Fill the pipette dropper with the specimen. Holding the dropper vertically, dispense 1 drop (about 10 µL) of whole blood,serum, plasma into the sample well,making sure that there are no air bubbles. Then add 1-2 drops (about 70-100 µL) of Sample Diluent immediately.
- Set up timer. Results can be read in 15 minutes. Don’t read result after 15 minutes.
PERFORMANCE CHARACTERISTICS
1. Positive Coincidence Rate: The test results of positive quality control are all positive.
2. Negative Coincidence Rate: The test results of negative quality control are all negative.
3. Analytical Specificity: The test results of specimen from non- infected by novel coronavirus should be negative.
4. Analytical Sensitivity: The detection result is positive when detection of a novel coronavirus IgG strongly positive serum 1:50 dilution sensitivity reference: The detection result is positive when detection of a novel coronavirus IgM strongly positive serum 1:50 dilution sensitivity reference.
5. Intra-Assay: There is no different test results of the same quality control in the same batch.
6. Inter-Assay: There is no different test results of the same quality control from different batch.
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