COVID 19 antibody testing kit

Rapid antibody test

To see if you've had corona.

Quantity: 30

Serological test for antibodies.

Corona test Antibodies Virus Rapid test 15min./covid-19 nCov-coV-2

 

Know your result within 15 minutes.

 

(The labs no longer stick to the test capacity)

 

 

Corona test instructions for use: Test Covid-19 Corona (quick test)
Take out the test kit and let it sit 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 well of the test strip in the S.


apply 2 drops of buffer to the opening of the test strip over the blood.

 

 


Read the result in 15 minutes.

(no longer reliable after 20 minutes.)


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.

IgG result
Relative sensitivity: 100% (86.0% -100%) *
Relative Specificity: 98.0% (89.4% -99.9%) *
Accuracy: 98.6% (92.3% -99.96%) *

IgM result
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

 

DESCRIPTION corona test.


The only rapid COVID-19 test for both IgM and IgG antibodies with proven clinical performance compared to RT-PCR.

Vitro In vitro diagnostic test
Determination Qualitative determination of the IgM and IgG antibodies of COVID-19
Μ 10 μL whole blood / serum / plasma
✅ Result after 15 minutes.
✅ For professional use only
T CE TüV Rheinland ISO 13485: 2016

Specifications and Features:
The COVID-19 IgM / IgG Rapid Test is an in vitro diagnostic test for the qualitative determination of COVID-19's IgM and IgG antibodies in human blood, serum, plasma or fingertip blood.


The test kit consists of test strip and buffer. It is intended for in vitro diagnostic use only and can be used in point-of-care testing, doctor's offices, 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 mouse monoclonal anti-human IgM antibody detects the COVID-19 IgM antibody. The IgG line coated with mouse monoclonal anti-human IgG antibody detects the COVID-19 IgG antibody. Cover the C line with antibody for quality control. 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 purplish red making it 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 purplish red, which is COVID -19 will yield IgG indicating that the antibody is positive.

If one of the IgG or IgM lines does not show color, the negative result is displayed. The test strip also contains a quality control line C, whether there is a test line or not, the quality control line C should appear purple-red. Test result is invalid if Quality Control Line C does not show color, this sample must be retested

INTERPRETATION OF TEST RESULTS
Positive result:

the COVID-19 IgM antibody is detected when the quality control line C and the detection line IgM are both colored and the detection IgG line is not colored, meaning that the COVID-19 IgM antibody is positive.
The COVID-19 IgG antibody is detected when the quality control line C and the detection IgG line are both colored and the detection IgM line is unstained, meaning that the COVID-19 IgG antibody is positive.
The COVID-19 IgG and IgM antibodies are detected when the quality control line C, the detection line IgM and IgG are both colored, meaning that both the COVID-19 IgG and IgM antibodies are positive.
Negative result:
if only quality control line C is stained, IgG and IgM detection lines are not stained, the COVID-19 IgM / IgG antibody will not be detected, which means the result is negative.
Invalid result:
The test result cannot be used for the diagnosis of COVID-19. If the result does not agree with the clinical evaluation, run more tests.
Do not use strong hemolytic samples.
Note: For in vitro diagnostic use.

We do not take back tests due to quality requirements

 

Composition:
Each test kit contains a test strip, the buffer, needle, pipette, alcohol wipe and Dutch manual.

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