For Comprehensive Screening and Monitoring COVID-19
Coronavirus update: May 9, 2020 total coronavirus cases up to 4.01 million cases. Top 20 coronavirus outbreak countries as bellow:
NO.1 Conronavirus US, 1,321,785 coronavirus cases
NO.2 Conronavirus Espana, 260,117 coronavirus cases
NO.3 Coronavrius Italy, 217,185 coronavirus cases
NO.4 Coronavirus UK, 211,364 coronavirus cases
NO.5 Coronavirus Russia, 187,859 coronavirus cases
NO.6 Coronavirus France, 176,079 coronavirus cases
NO.7 Coronavirus Germany, 170,588 coronavirus cases
NO.8 Coronavirus Brasil, 146,894 coronavirus cases
NO.9 Coronavirus Turkey, 135,569 coronavirus cases
NO.10 Coronavirus Iran, 104,691 coronavirus cases
NO.11 Coronavirus China, 82,887 coronavirus cases
NO.12 Coronavirus Canada, 66,434 coronavirus cases
NO.13 Coronavirus Peru, 61,847 coronavirus cases
NO.14 Coronavirus In India, 59,695, coronavirus cases
NO.15 Coronavirus Belgium, 52,011 coronavirus cases
NO.16 Coronavirus Netherlands, 42,093 coronavirus cases
NO.17 Coronavirus Saudi Arabia, 35,432 coronavirus cases
NO.18 Coronavirus Mexico, 31,522 coronavirus cases
NO.19 Coronavirus Switzerland, 30,207 coronavirus cases
NO.20 Coronavirus Ecuador, 28,818 coronavirus cases
Above datas from https://www.worldometers.info/coronavirus/
Coronavirus are a large family of viruses which may cause illness in animals or humans. In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The most recently discovered coronavirus causes coronavirus disease COVID-19.
IgM provides the first line of defense during viral infections, followed by the generation of adaptive, high affinity IgG responses for long term immunity and immunological memory. Therefore testing of COVID-19 IgM and IgG antibodies is an effective method for the rapid diagnosis of COVID-19 infection. Furthermore, detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, whereas detection of COVID-19 IgG antibody indicates a later stage of infection.
The COVID-19 IgG/IgM Rapid Test is intended for use to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro. It's used as a supplementary indicator for the detection of suspected new coronavirus nucleic acid negative cases, or is used in coordination with nucleic acid detection in the diagnosis of suspected cases. It can not be used as a basis for the diagnosis and exclusion of new coronavirus infection pneumonia, and is not suitable for general population screening.
Recommended Group of people to be tested:
High Risk: Obvious clinical, Symptoms but Nucleic test Negative patient
Suspected: Family members of Confirmed or Suspected patients, Recent close contact person
Susceptible: Elderly, children or Immuno-suppressive persons
Confirmed: Continue monitoring of disease progress and monitoring of convalescent
Finger Stick/Whole Blood Sampling And Testing Procedure:
Serum/Plasma Testing Procedure:
Interpretation For Results
1.Visible C-line and G-line indicates covid-19 IgG positive
2.Visible C-line and M-line indicates covid-19 IgM positive
3.Visible C-line, G-line and M-line indicates covid-19 IgG & IgM positive
Visible C-line indicates covid-19 IgG & IgM negative
Total coronavirus cases 600 patients.
The Specificity: 98.43%
The Sensitivity: 87.54%
COVID-19 IgG/IgM Rapid Test Results & Clinic Significance
Coronavirus Cases COVID 19 Clinic Significance
1. Nucleic Acid (PCR) positive, but IgM & IgG both negative. Patients may be in the ‘window period’ of SARS-COV-2 (Coronavirus) infection.
2. Nucleic Acid (PCR) and IgM are positive, but IgG negative. Patient may be in the early stage of infection, and the body’s immune response first produced the antibody IgM, but no IgG was produced or the IgG content did not reach the detection limit of the diagnostic reagent.
3. Nucleic Acid (PCR) and IgG are positive, but IgM negative. Patients may be in late or recurrent stage of infection.
4. Nucleic Acid (PCR), IgG and IgM all positive. Patient is in the active phase of infection, but the human body has developed some immunity to SARS-COV-2(Coronavirus) (the persistent antibody IgG has been produced).
5. IgM positive, Nucleic Acid (PCR) and IgG negative. Patient may be in the acute phase of SARS-COV-2(Coronavirus) infection. At this time, nucleic acid test result need to be considered (PCR may be false negative).
6. IgG positive, Nucleic Acid (PCR) and IgM negative. Patient may have been infected with SARS-COV-2 in the past, but the patient has been recovered or the virus in body has been cleared.
7. Nucleic Acid (PCR) negative, but IgM & IgG both positive. Patient has recently been infected with SARS-COV-2(Coronavirus) and is in the recovery stage. Or the nucleic acid test result is false negative and the patient is in the active infection stage.
Covid Test (Colloidal Gold) vs. Nucleic Acid (PCR)
Covid Test by colloidal gold rapit test
Test time: 15 minutes only
Operation: Highly portable and stable test
Portability: Can be conducted at Point of Care including certified small labs, clinics, patient bedside. Simple without supporting equipment required, even home test perform easy
Covid Test by Nucleic Acid (PCR)
Test time: 3-4 hours
Operation: Complex with supporting equipment and operating skills required
Portability: Requires highly complex equipment with perform skills and only available in large hospitals
Advantage of COVID TEST
Positive IgM indicate early phase of infection
Cover early, mid and late phase of disease, avoid missing
2 Tests on one cassette, result in 15minutes
Individual test avoids cross-infection
Contents of the Kit
1. Test cassette
2. Sample Dilution
3. Capillary Sampler
4. Instructions For Use
5. Materials not provided but required:
Lancet | Alcohol wipes | Gloves | Timer
Package Size: 20 Test/box