Product Details
SARS-CoV-2 IgM/IgG rapid assay kit (Colloidal Gold)
Instruction for Use
【Product
Name】
SARS-CoV-2
IgM/IgG rapid assay kit (Colloidal Gold)
【Packing】50
tests / kit
【Catalogue
Number】A147-POC
【Intended
Use】
SARS-CoV-2
IgM/IgG rapid assay kit (Colloidal Gold) is intended for the
qualitative detection of IgM and IgG
antibodies
against SARS-COV-2 in human specimen of serum/plasma/ whole
blood.
SARS-CoV-2
IgM/IgG rapid assay kit (Colloidal Gold) is a fast, on-site, and
accurate detection of IgM/IgG antibody
against
SARS-COV-2, with positive result of IgM antibody indicating a
recent infection, while positive result of
IgG
antibody signaling a longer or previous infection, and IgM
antibodies can be detected on the day 7 of infection
and the day
3 of onset.
SARS-CoV-2
IgM/IgG rapid assay kit (Colloidal Gold) is aid to diagnosis, it
can be used as a supplementary
detection
indicator in conjunction with nucleic acid detection in the
diagnosis of suspected cases.
【Detection
Principle】
The
SARS-CoV-2 IgM/IgG rapid assay kit (Colloidal Gold) is to mark
the specific antigen of SARS-COV-2
with a
colloida gold and to coat the anti-human IgM and anti-human IgG
monoclonal antibody as the detection line.
When
detecting, if there is antibody IgM(/ IgG) of SARS-COV-2 in
certain concentration in the tesing sample, the
antibody
will combine with the specific antigen of SARS-COV-2 marked by
colloidal gold and forms a compound.
Under the
function of chromatography, it moves to the detection line and
the coat is captured by the antibody, thus
a
claret-colored line will appear. When there is SARS-COV-2 IgM in
the testing sample under test, compound of
IgM-colloidal
gold marked antigen is formed, and is captured by the anti-human
IgM in detection line for IgM.
When there
is SARS-COV-2 IgG antibody in the testing sample, compound of IgG
-colloidal gold marked antigen
is formed
and captured by the anti-human IgG in another detection line for
IgG. In case both the IgM and IgG
antibodies
of SARS-COV-2 present in the testing sample, compounds of
IgM-colloidal gold marked antigen and
IgG-colloidal
gold marked antigen are formed, which are also captured
respectively by the anti-human IgM
detection
line and the anti-human IgG detection line. Otherwise, compound
of antibody-colloidal gold marked
antigen
will not be formed, no claret-color will appear in both detection
lines for IgM and IgG. No matter if there
is the
antibody to be tested in the sample, claret-color line will
appear as quality control to monitor the strip valid
and the
operation procedures. The testing results can be read through
nake eyes and inteprate on basis of the color
line to
determine the infection condition of SARS-COV-2.
【Key
Components】
Component
Specification
QuantityVersion2.0
2/6
SARS-CoV-2
Detection reagent card
1pcs/bag
50
bags
Sample
Diluent Solution
5mL/bottle
2
bottles
The
package inlucds test card, dissecant and PTP bag. The test card
are assembled by plastic shell, PVC back board,
sample
pad, conjunct pad, nitrocellulose membrane (including M
detection line with anti-human IgM antibody
coated, G
detection line with anti-human IgG antibody coated, quality
line C with quality control antibody coated),
and
absorbent pad.
【Storage
and shelf-life】
Storage
condition: The detection reagent card and Sample diluent
solution shall be storage at 4-30℃.
Shelf-life:
tentatively set for 12 months
See
production date and expiry date on package label.
【Sample
Requirements】
Applicable
specimen of the kit includes serum/plasma/ whole blood
specimens. Specimens should be collected by
standard
protocol.
The
sample could be stored at 2-8℃ for not longer than 5 days if it
cannot be tested immediately.
【Detection
Method】
1.Reagent
Preparation:
Take out
the testing card and Sample diluent solution and keep at
ambient temperature.
2. Add
sample and chromatography:
After
opening the package of the testingcard and Sample diluent
solution, pippette 10μL
of
serum/plasma sample or
20μL
whole blood sample into the sample hole followed by 3 drops of
Sample diluent solution with drip bottle.
Keep it
at ambient temperature for 15 minutes for testing and then read
the result.
【Results
Interpretation 】
For more detailed instructions, interested customers can contact
our customer service staff.
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