Hangzhou Aichek Medical Technology Co.,Ltd |
|
Professional and Convenient COVID-19 antibody rapid test device
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.
[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.