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Instructions for Use: Test Covid-19 Corona (Quick Test)
- Take out the test kit and leave it at room temperature for at least 30 minutes.
- Place a test strip on a dust-free clean surface.
- Apply 2 drops of whole blood / serum / plasma / fingertip blood to the sample opening of the test strip.
- apply 2 drops of buffer to the sample opening of the test strip.
- Read the result in 15 minutes.
Read the result in 15 minutes.
IgM only: early phase
IgM and IgG: middle phase
IgG only: late stage
Sensitivity and specificity
The 2019 nCoV IgG / IgM Rapid Test Cassette was compared to a leading commercial PCR. The results show that 2019-nCoV IgG / IgM Rapid Test Cassette has high sensitivity and specificity.
Relative sensitivity: 100% (86.0% -100%) *
Relative Specificity: 98.0% (89.4% -99.9%) *
Accuracy: 98.6% (92.3% -99.96%) *
Relative sensitivity: 85.0% (62.1% -96.8%)
Relative Specificity: 96.0% (86.3% -99.5%)
Accuracy: 92.9% (84.1% -97.6%)
* 98% confidence interval
corona test, rapid test, covid-19 test
The only COVID-19 rapid test for both IgM and IgG antibodies with proven good clinical performance compared to RT-PCR.
Vitro In vitro diagnostic test
Bepaling Qualitative determination of the IgM and IgG antibodies of COVID-19
Μ 10μL whole blood / serum / plasma
✅ Result after 15 minutes.
✅ For professional use only
T CE TüV Rheinland ISO 13485: 2016
Specifications and functions:
The rapid test COVID-19 IgM / IgG is an in vitro diagnostic test for the qualitative determination of COVID-19's IgM and IgG antibodies in human whole blood, serum, plasma or fingertip blood.
The test kit consists of test strip and buffer. It is for in vitro diagnostics only and can be used in point of care testing, doctor's practices, hospitals and central laboratories.
The test kit is based on immunoassay technology. The test strips contain:
1) Conjugate Pad (tie pad test strip) recombinant Covid 19 antigen coated with colloidal gold and quality control antibody gold marker.
2) NC membrane: coated with two detection lines (IgG line and IgM line) and one quality control line (C line). The IgM line coated with murine anti-human IgM monoclonal antibody detects the COVID-19 IgM antibody. The IgG line coated with murine anti-human IgG monoclonal antibody detects the COVID-19 IgG antibody. The C line covered with quality control antibody. When the sample is added to the sample opening of the test strip, it moves forward along the test device. If the sample contains IgM antibodies, antibodies will bind to the virus antigen labeled with colloidal gold and then sandwich with the coated anti-human IgM monoclonal antibody on the IgM line, the IgM line will appear purple-red, causing the COVID-19 IgM is called antibody positive.
If the sample contains IgG antibodies, antibodies will bind to the virus antigen labeled with colloidal gold and then sandwich with the coated anti-human IgG monoclonal antibody on the IgG line, the IgG line will appear purple-red, which will COVID-19 IgG indicating antibody is positive.
If one of the lines IgG or IgM shows no color, the negative result is displayed. The test strip also includes a quality control line C, whether there is a test line or not, quality control line C should be shown purple red. Test result is invalid if quality control line C shows no color, this sample must be retested
INTERPRETATION OF TEST RESULTS
the COVID-19 IgM antibody is detected when the quality control line C and the detection line IgM are both stained and the detection IgG line is not stained, meaning that the COVID-19 IgM antibody is positive.
The COVID-19 IgG antibody is detected if the quality control line C and the detection IgG line are both stained and the detection IgM line is not stained, which means that the COVID-19 IgG antibody is positive.
The COVID-19 IgG and IgM antibodies are detected if the quality control line C, the detection line IgM and IgG are both stained, meaning that both the COVID-19 IgG and IgM antibodies are positive.
if only quality control line C is stained, IgG and IgM detection lines are not stained, the COVID-19 IgM / IgG antibody is not detected, meaning the result is negative.
if the quality control line C is not colored, regardless of whether the detection line IgG / IgM is colored or not, the result is invalid and must be retested.
The test result cannot be used for the diagnosis of COVID-19. If the result does not match the clinical evaluation, perform more tests.
Do not use strong hemolytic samples.
Note: For in vitro diagnostic use.
we only sell to BIG healthcare institutions / practices
We do not take back tests due to quality requirements
Each test kit contains a test strip, the buffer, needle, pippette, alcohol swab and Dutch manual.
You will find the package leaflet on our website.
The test strip contains:
Binding pad: Recombinant COVID-19 antigen labeled with colloidal gold and quality control antibody gold marker.
NC membrane: coated