Care Test Biotech Ltd |
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SARS-COV-2 Infected COVID 19 Antibody Rapid Lab Test IgM and IgG Detection kit
Intended Use
Detection of Covid-19 IgM and IgG in serum , plasma or whole blood
including finger tip blood for in vitro diagnostic purpose.
Introduction
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.
Safety measure:
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 .
Assay principle
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.
Kit Components
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.
General Precautions
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.
Sample Collection
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.
Test Procedure
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.
Result analysis:
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.