INTENDEDUSE

The SARS-CoV-2 antigen IVD kit NASAL is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in human NASAL, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronvirus antigen. It will provide information for clinical doctors to prescribe correct medications.

SUMMARY

COVID-19 is an acute respiratory infectious disease caused by the novel coronavirus SARS-CoV-2. The novel coronavirus SARS-CoV-2 belongs to the β genus, which is an enveloped, non-segmented RNA virus. Currently, the patients infected with the novel coronavirus are the main source of infection, but asymptomatic infected people can also be a source of infection. Based on current epidemiological studies, the incubation period is 1 to 14 days, in most cases 3 to 7 days. The main manifestations are fever, loss of smell and taste, malaise and fatigue, and dry cough. In some cases, there is a runny nose, shortness of breath, muscle pain, and diarrhea.

PRINCIPLE

SARS-CoV-2 Antigen IVD Kit NASAL is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to qualitatively determine the presence of nucleocapsid protein (N-Protein) antigen from SARS-CoV-2 in direct nasopharyngeal swab. When the sample is dropped into the sample well, SARS-CoV-2 antigens in the sample are bound by colloidal gold-labeled monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2. This complex migrates on the membrane via capillary action to the test region (T), where it is captured by the mouse monoclonal anti‑SARS‑CoV‑2. If the SARS-CoV-2 antigens are present in the sample, a colored test line becomes visible in the T line. To serve as a procedural control, a colored line always appears in the control region (C), if the test has performed properly.

REAGENTS

The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coroinavirus; the reaction membrane contains the secondary antibodies for Novel coroinavirus,and the polyclonal antibodies against the mouse globulin, which are  pre-  immobilized on the membrane.

DIRECTIONS FOR USE

Allow the test device, specimen, sample 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 collection 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.

Oropharyngeal Swab Specimen Collection :

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.