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2019-nCOV IgGIgM Rapid Test Device(single serving)

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Sensitivity and Specificity: The 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device has been compared to a leading commercial RT-PCR testing using clinical specimens.The results show that the 2019-nCoV/COVID-19 IgG/IgM Rapid Test Device has a high sensitivity and specificity.

For IgG testing:

Method RT-PCR Total Results
2019-nCOV IgG/IgM Rapid Test Device Results Positive Negative
Positive 233 2 235
Negative 35 287 322
Total Results 268 289 557

Relative Sensitivity:233/268=86.94%(95%CI*:82.35%-90.49%)

Relative Specificity:287/289=99.31% (95%CI*:97.52%-99.92%)

Accuracy:520/557=93.36% (95%CI*: 90.96%-95.16%)

*Confidence Interval

For IgM testing

Method RT-PCR Total Results
2019-nCOV IgG/IgM Rapid Test Device Results Positive Negative
Positive 223 7 230
Negative 45 282 327
Total Results 268 289 557

Relative Sensitivity:223/268=83.21% (95%CI*:78.19%-87.48%)

Relative Specificity:282/289=97.58% (95%CI*: 95.07%-99.02%)

Accuracy: 505/557=90.66% (95%CI*: 87.94%-92.95%)

*Confidence Interval

The 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of IgG&IgM antibody of Coronavirus Disease 2019 in human whole blood,serum,or plasma as an aid in the diagnosis of COVID-19 infections.

INTENDED USE: The 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of IgG&IgM antibody of Coronavirus Disease 2019 in human whole blood,serum,or plasma as an aid in the diagnosis of COVID-19 infections.

SUMMARY: COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

DIRECTIONS FOR USE: Allow the test device,specimen,buffer,and/or controls to reach room temperature (15-30°C) prior to testing. 1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible. 2. Place the test device on a clean and level surface. ? For Serum or Plasma Specimens: Using the provided 10μL disposable pipette,draw the specimen up to the Fill Line,and transfer 10μL serum/plasma to the specimen well of the test device, then add 2 drops of buffer and start the timer. ? For Whole Blood (Venipuncture/Fingerstick) Specimens: Using the provided 10μL disposable pipette,and transfer 1 drop of whole blood (approximately 20μL) to the specimen well of the test device,then add 2 drops of buffer and start the timer. Note: Specimens can also be applied using a micropipette. 3. Wait for the colored line(s) to appear.Read results at 10 minutes.Do not interpret the result after 15 minutes.

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PRINCIPLE: This kit uses immunochromatography.The test card contains:1) colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody gold markers;2) two detection lines (IgG and IgM lines) and one quality Control line (C line) of nitrocellulose membrane. The M line is immobilized with a monoclonal anti-human IgM antibody for detecting a novel coronavirus IgM antibody; the IgG line is immobilized with a reagent for detecting a novel coronavirus IgG antibody; and the C line is immobilized with a quality control antibody. When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary.If the sample contains an IgM antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen. The immune complex will be captured by the anti-human IgM antibody immobilized on the membrane to form a purple-red M line,showing that the novel coronavirus IgM antibody is positive. If the sample contains an IgG antibody,the antibody will bind to the colloidal gold-labeled novel coronavirus antigen,and the immune complex will be captured by the reagent immobilized on the membrane to form a purple-red IgG line,indicating that the novel coronavirus IgG antibody is positive. If the test IgG and IgM lines are not colored,a negative result is displayed.The test card also contains a quality control line C.The fuchsia quality control line C should appear regardless of whether a test line appears.The quality control line is a color band of the quality control antibody immune complex. If the quality control line C does not appear, the test result is invalid, and the sample needs to be tested again with another test card.


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