ImCoV-AgTM : Rapid Antigen Test for COVID19
(Co-developed by IMGENEX India Pvt. Ltd. and ICMRRegional
Medical Research Centre, Bhubaneswar.)
- REFERENCE NUMBER: 70-1002
- PACK SIZE: 25
- ASSAY PRINCIPLE:
ImCoV-AgTM COVID-19 Antigen Rapid test device has two precoated
lines, âCâ Control line, âTâ Test line on the surface of the
nitrocellulose membrane. Both the control line and test line in the
result window are not visible before applying any specimens.
Mouse monoclonal anti-SARS-CoV-2 antibody is coated on the test
line region and Goat anti Mouse IgG antibody is coated on the
control line region. Mouse monoclonal anti-SARS-CoV-2 and
Mouse IgG antibody conjugated with color particles are used as
detectors for SARS-CoV-2 antigen device. During the test, SARSCoV-
2 antigen in the specimen interacts with monoclonal anti-
SARS-CoV-2 antibody conjugated with color particles making
antigen-antibody color particle complex. This complex migrates on
the membrane via capillary action until the test line, where it will
be captured by the mouse monoclonal anti-SARS-CoV-2 antibody.
A colored test line would be visible in the result window if SARSCoV-
2 antigens are present in the specimen. The intensity of
colored test line will vary depending upon the amount of SARSCoV-
2 antigen present in the specimen. If SARS-CoV-2 antigens
are not present in the specimen, then no color appears in the test
line. The control line is used for procedural control, and should
always appear if the test procedure is performed properly and the
test reagents of the control line are working.
- INTENDED USE:
ImCoV-AgTM COVID-19 Antigen Rapid test device. lateral flow through
immuno- chromatographic test for the qualitative detection of antigen
specific to novel coronavirus (SARS- CoV-2) in human nasopharynx. It
is intended to be used by healthcare professionals as an aid in the
early diagnosis of infection with SARS-CoV-2 coronavirus.
- CONTENTS OF KIT:
ImCoV-AgTM COVID-19 Antigen Rapid test device kit contains
following items to perform the assay.
Kit Components
|
Quantity
|
Individually foil-pouched test devices with desiccant
|
25 Nos
|
Nasopharyngeal swab
|
25 Nos
|
Extraction buffer tube with nozzle
|
25 Nos
|
Extraction Buffer Bottle(4ml)
|
3 Nos
|
Instruction Manual
|
1 No
|
- TEST PROCEDURE DIAGRAM:
Step 1: Sample collection and extraction.
- Step 2: Test Operation.