SARS-CoV-2 (Covid-19) Antigen Rapid Test Kit (Immunochromatography)
Intended use:
Used for in vitro qualitative detection of the novel coronavirus (SARS-CoV-2) N protein antigen
In human nasal or saliva swabs.Antigen testing is generally used in the acute infection period,that is,Sample testing within 7 days of the onset of symptoms in suspected people.
The positive result of the antigen test can be used for early triage and rapid management of
Suspected infected people,but the positive result only indicates the presence of the novel
Coronavirus N antigen in the sample,and cannot be used as the basis for the diagnosis and
Exclusion of pneumonia caused by the novel coronavirus.It should be combined with nucleic acid
testing,imaging and other diagnostic information,medical history,and contact history to
Determine the status of infection.
The negative result cannot rule out novel coronavirus infection,and it cannot be used alone as a
Basis for treatment and disease management decisions.Suspected infected people with the antigen
Test results of positive and negative should be further nucleic acid testing.
Coronavirus belongs to the order Nidoviridae, and the Coronavirus family is divided into three
Genera of α,β,and γ.α and β are only pathogenic to mammals,and γ mainly causes bird infections.
CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets.
There is also evidence that it can be transmitted through fecal or oral routes.
Until now,there are 7 kinds of human coronaviruses (HCoV) that cause human respiratory
diseases:HCoV-229E,HCoV-OC43,SARS-CoV,HCoV-NL63,HCoV-HKU1,MERS-CoV and
COVID-19,Is an important pathogen of human respiratory infections.Among them,the clinical
Manifestations of SARS-CoV-2 virus are systemic symptoms such as fever and fatigue,
Accompanied by dry cough,dyspnea, etc.,which can rapidly develop into severe pneumonia,
Respiratory failure,acute respiratory distress syndrome,septic shock,and multiple organ failure,
Severe acid-base metabolism disorder,etc.,even life-threatening.
Functions and Principles:
The conjugate-pad of this test strip is respectively covered with mouse anti-novel coronavirus
Monoclonal antibody 1 with colloidal gold as the color marker.The detection line(T) on the
Nitrocellulocellulose membrane is covered with mouse anti-novel Coronavirus monoclonal
Antibody 2 and the quality control line(C) is covered with sheep anti-mouse IgG polyclonal
antibody.When testing,when the sample to be tested contains the novel coronavirus ,it combines
With the colloidal gold-labeled novel coronavirus monoclonal antibody to form an immune
complex,which is captured and enriched at the detection line(T) by the reagents fixed on the
membrane.The colloidal gold-labeled antibody diffuses to the quality control line(C) area and is
Captured by the secondary antibody to form a purple-red band in the quality control area.
DIRECTIONS FOR USE:
Allow the test device, specimen, sampie extraction buffer to equilibrate to room temperature (15- 30°C) prior to testing.Do not place
anything in the mouth including food, drink, gum, tobacco, water and mouth cleaning products for at least 10 minutes prior to callection
of oropharyngeal swab.
Nasopharyngeal Swab Specimen Collection :
1.Remove the swab from the package.
2.Tilt patient's head back about 70°.
3.Insert the swab through the nostril parallel to the palate(not upwards) until resistance is encountered or the
distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx.
(Swab should reach depth equal to distance from nostrils to outer opening of the ear.) Gently rub and roll the
swab. Leave swab in place for several seconds to absorb secretions.
4.Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is
not necessary to collect specimens from both sides if the tip of swab is saturated with fluid from the first collection. if
a deviated septum or blockage creates difficulty in obtaining the specimen from one nostril, use the same swab to
obtain the specimen from the other nostril.
Nasal Swab Specimen Collection :
1.While gently rotating the swab, insert swab about 2.5 cm(1 inch) into nostril until resistance is met at
turbinates.
2.Rotate the swab several times against nasal wall and repeat in other nostril using the same swab.
Nasal swab specimens Cllection:
Insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsillar pillars and posterior
oropharynx and avoid touching the tongue, teeth, and gums.
Specimen Transport and Storage:
Do not return the swab to the original swab packaging. Freshly collected specimens should be processed as soon as possible, but
no later than one hour after specimen collection, Specimen collected may be stored at 2-8°C for no more than 24 houre; Store
at-70°C for a long time, but avoid repeated freeze-thaw cycles.
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