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New CoVID19 IgG/IgM Rapid Test

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  • Cat NO.:SL-CO
  • Product Spec:40pcs/boxes
  • Price:$4
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  • Manual

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Shelf life:2years

nCoV-19 IgG/IgM Rapid Test Device

Package Insert
Specimens: Whole Blood/Serum/Plasma
Version: 02
Effective Date: 2020-03
For professional in vitro diagnostic use only.
INTENDED USE
The nCoV-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and
differentiation of IgG anti–nCoV-19 virus and IgM anti-nCoV-19 virus in human whole blood, serum or plasma.
Itis intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with
nCoV-19 viruses. Any reactive specimen with the nCoV-19 IgG/IgM Rapid Test must be confirmed with
alternativetestingmethod(s).
INTRODUCTION
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and
birds and that cause respiratory, enteric, hepatic, and neurologic diseases.Six coronavirus species are known to
cause human disease. Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent and typically cause
common cold symptoms in immunocompetent individuals. The two other strains — severe acute respiratory
syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) — are
zoonotic in origin and have been linked to sometimes fatal illness. Given the high prevalence and wide
distribution of coronaviruses, the large genetic diversity and frequent recombination of their genomes, and
increasing human–animal interface activities, novel coronaviruses are likely to emerge periodically in humans
owingtofrequentcross-speciesinfectionsandoccasionalspilloverevents.
ThenCoV-19IgG/IgMRapidTestdetects IgGandIgManti-nCoV-19virus inone testwithin15minutes.Thetest
isuser friendly,withoutcumbersomelaboratoryequipment,andrequiresminimalstafftrainings.
PRINCIPLE
The nCoV-19 IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative membrane-based
immunoassay for the detection of nCoV-19 antibodies in whole blood, serum, or plasma. This test consists of
two components, an IgG component and an IgM component. In the Test region, anti-human IgM and IgG is
coated.During testing,the specimen reacts with nCoV-19 antigen-coated particles in the test strip. The mixture
then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-
human IgM or IgG in test line region. If the specimen contains IgM or IgG antibodies to nCoV-19, a colored line
willappear intestlineregion.
Therefore, if the specimen contains nCoV-19 IgM antibodies, a colored line will appear in test line region M. If
the specimen contains nCoV-19 IgG antibodies, a colored line will appear in test line region G. If the specimen
does not contain nCoV-19 antibodies, no colored line will appear in either of the test line regions, indicating a
negative result. To serve as a procedural control, a colored line will always appeared in the control line region,
indicatingthatthepropervolumeofspecimenhasbeenaddedandmembranewickinghasoccurred.
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