|Place of Origin:||China|
|Brand Name:||Care Test|
|Minimum Order Quantity:||2000pcs|
|Delivery Time:||Depending on order QTY|
|Methodology:||Lateral Flow Immunoassay||Specimen:||Serum, Plasma Or Whole Blood|
|Definition:||Qualitative Assay||Test Item:||IgM And IgG Antibodies|
|Format:||Cassette||Time To Result:||Within 15 Min|
IgG Detection Kit,
IgM Detection Kit
SARS-COV-2 Infected COVID 19 Antibody Rapid Lab Test IgM and IgG Detection kit
Detection of Covid-19 IgM and IgG in serum , plasma or whole blood including finger tip blood for in vitro diagnostic purpose.
Covid-19 first emerged in December 2019 in Wuhan, China. The cause of the disease was confirmed as a new kind of coronavirus, this virus is transmitted through air from people to people. In two months, the infection has quickly spread in China and to a number of countries around the world.
Covid-19 virus causes over 2% mortality, there is 7 to 14 days incubation period. The current diagnostic method is majorly by PCR test, but its overall sensitivity is 50 to 60% and is limited by the user with the special trainning and special instruments. There is an urgent need to develop a simple and fast test to screen large population and unsymptomatic infected people. Infectious disease usually produces specific IgM antibody at 2 to 4 days after the infection, while specific IgG antibody appears after 5 to 7 days. Compared to other test, this test is more convenient with low cost, it can be performed in field, mobile hospital and laboratory.
Covid-19 antibody test must be manipulated in a biosafety Level 3 facility, or with good personal protection, specimen deposit have to follow WHO or local health authority guidline .
The recombinant Covid-19 nuceloprotein antigen is used in the test, serum, plasma or whole blood from Covid-19 infected patient is loaded to the device, the specific Covid-19 antibodies in specimen will bind to gold-conjugated Covid-19 nucleoprotein antigens forming antibody – colloid gold-antigen complex. While the complex migrates along nitrocellulose membrane, the complex is captured on the test lines coated with anti-human IgM or IgG causing a pink to deep pink band at the IgG or IgM test line. The signal intensity is variable depending on the amount of specific antibody present in specimen. A red control line should always develop over control line indicating the proper performance.
Each test kit contains: 1. A pouch 2. Pouch contains one cassette test device 3. Each 25 tests with one 3 ml dropper bottle with assay buffer Components supplied By User
1. Timer 2. Blood collection device
Stability and Storage Conditions
Covid-19 IgG / IgM test kit is stable at room temperature between 10-28’C for two and half year in the unopened pouches.
DO NOT FREEZE the kit or expose to temperature extremes.
The test is for In Vitro diagnosis only.
Appropriate infection control, personal protection and handling procedures should be followed – do not smoke, eat or drink in the area where the test is to be performed. Use protective clothing, gloves and goggles when handling samples and when performing the test.
Do not pipette any samples or reagents by mouth.
All materials should be considered as potentially infectious. To disinfect, either autoclave materials at 121.5oC for 1 hour or treat with sodium hyprochlorite (1 percent solution).
Do not use test beyond the expiration date indicated.
Serum, plasma or whole blood is used for this device. The test works best on fresh samples. If testing cannot be done immediately, they should be stored at 2-8oC after collection for up to 3 days. If testing can not be done within 3 days, serum can be stored frozen at –20oC or colder.
1. Remove test cards from the pouche before your test, lay over a clean flat surface.
2. In case, the tested samples are in frozen status, the sample has to be sit in room temperature to completely thawing, and mixed well for test.
3. Add 10ul serum or plasma or whole blood ( or finger tip blood )to the well over the test card using included pipette.
4. Follow adding sample, add two or three drops assay buffer from the dropper bottle.
5. Results are then read 15 to 30 minutes, make sure control line is always positive.
Reading test results :
PLEASE NOTE: When reading this test, a clear visible line over IgG or IgM area of the card within the prescribed time limit indicates a positive result.
1. Early Covid-19 IgM: positive or weak positive without Covid-19 IgG between 2 to 5 days of symptom may indicate an early stage of Covid19 infection;
2. Positive Covid IgM and IgG may occur after 5 to 6 days after symptom;
3. Strong Covid-19 IgG without Covid-19 IgM may indicate late stage infection, or recovery patients.
Limitation of the Test
This instruction should be followed carefully and performed properly.
Coivd-19 IgM / IgG test is designed to detect antibodies against Covid-19 virus in serum or plasma. Testing of any other body fluids has not been validated and may not yield appropriate results.
For samples that test positive by Covid-19 IgM/IgG test, more specific confirmatory testing may be done. A clinical evaluation of the patient’s situation and history should also be made before a final diagnosis is established.