For professional and in vitro diagnostic use only.
| Product Name | OEM SARS-COV-19 IgG IgM Antibody Rapid Test Kit |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box |
| Storage | 2℃-30℃ |
[INTENDED USE]
The COVID-19 IgG/IgM Rapid Test device is a lateral flow
chromatographic immunoassay for the qualitative detection of
antibodies (IgG and IgM) to Novel coronavirus in human Whole
Blood/Serum/Plasma. It provides an aid in the diagnosis of
infection with Novel coronavirus.
[SUMMARY]
The novel coronaviruses belong to the β genus. COVID-19 is an acute
respiratory infectious disease. People are generally susceptible.
Currently, the patients infected by the novel coronavirus are the
main source of infection; asymptomatic infected people can also be
an infectious source. Based on the current epidemiological
investigation, the incubation period is 1 to 14 days, mostly 3 to 7
days. The main manifestations include fever, fatigue and dry cough.
Nasal congestion, runny nose, sore throat, myalgia and diarrhea are
found in a few cases.
[PRINCIPLE]
The COVID-19 IgG/IgM Rapid Test device is a qualitative membrane
strip based immunoassay for the detection of antibodies (IgG and
IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. The
test device consists of: 1) a burgundy colored conjugate pad
containing Novel coronavirus recombinant envelope antigens
conjugated with Colloid gold (Novel coronavirus conjugates), 2) a
nitrocellulose membrane strip containing two test lines (IgG and
IgM lines) and a control line (C line). The IgM line is pre-coated
with the Mouse anti- Human IgM antibody, IgG line is coated with
Mouse anti-Human IgG antibody. When an adequate volume of test
specimen is dispensed into the sample well of the test device, the
specimen migrates by capillary action across the device. IgM
anti-Novel coronavirus, if present in the specimen, will bind to
the Novel coronavirus conjugates. The immunocomplex is then
captured by the reagent pre-coated on the IgM band, forming a
burgundy colored IgM line, indicating a Novel coronavirus IgM
positive test result. IgG anti-Novel coronavirus if present in the
specimen will bind to the Novel coronavirus conjugates. The
immunocomplex is then captured by the reagent coated on the IgG
line, forming a burgundy colored IgG line, indicating a Novel
coronavirus IgG positive test result. Absence of any T lines (IgG
and IgM) suggests a negative result. To serve as a procedural
control, a colored line will always appear at the control line
region indicating that proper volume of specimen has been added and
membrane wicking has
occurred.
[WARNINGS AND PRECAUTIONS]
• For in vitro diagnostic use only.
• For healthcare professionals and professionals at point of care
sites.
• Do not use after the expiration date.
• Please read all the information in this leaflet before performing
the test.
• The test device should remain in the sealed pouch until use.
• All specimens should be considered potentially hazardous and
handled in the same
manner as an infectious agent.
• Because there is a window period for the time when the body
produces antibodies
after infection and the types and amounts of antibodies produced by
different human
bodies at different time periods are various, it will cause
individual differences in
actual test results.
• The used test device should be discarded according to federal,
state and local
regulations.
