Hotgen 2019-Ncov Ag Autotest

General Indications

Eugene Covid-19 Antigen Rapid Test is an immunochromatographic test for the rapid qualitative detection of the COVID-19 antigen through nasopharyngeal swabs on individuals, as an aid for initial diagnostic and epidemiological investigation.

Product Specifications

Eugene Covid-19 Antigen Rapid Test is an in vitro diagnostic test for professional use.
This product is used for the qualitative in vitro detection of the COVID-19 antigen in throat swabs and nasal swabs intended for use on people. The Coronavirus (CoV) belongs to the Nestovirus and Coronaviridae families, and is divided into three genera: α, β, and γ. The α and β genera are only pathogenic to mammals, while the γ genus primarily causes avian infections. CoV is mainly transmitted through direct contact with secretions or through aerosol and droplets. It has also been shown that it can be transmitted via the fecal-oral route. There are 7 types of human coronaviruses (HCOV) that cause respiratory diseases: HCOV-229E, HCOV-OC43, SARS-COV, HCOV-NL63, HCOV-HKU1. MERS-CoV and SARS-CoV2, these are important pathogens of human respiratory infections. 2019-nCoV can cause COVID-19 (Corona Virus Disease 2019) and the clinical manifestations are systemic symptoms such as fever and fatigue, accompanied by dry cough and dyspnea, etc., which can rapidly degenerate into severe pneumonia, respiratory failure and acute breathing, stress syndrome, septic shock, multiple organ collapse, severe acid-base metabolic disorders, and even life-threatening situations.

Test Principle
The reagent uses the principle of the double sandwich complex of antibodies combined with colloidal gold immunochromatography. When an adequate amount of the test sample is added to the designated hole on the test cassette, the sample will move forward along the cassette, passing through the absorbent part. If the sample contains the COVID-19 antigen, it will bind to the colloidal gold COVID-19 antibody. The immune complex binds to the COVID-19 antibody forming another visible sandwich complex in the T detection line (line T), showing that the result is positive. The cassette also contains a control line C that should appear regardless of whether a test line is present or not. The control line C represents the control line of the immune antibody complex. If the C line does not appear, the test result is invalid, and the test must be repeated.

Instructions for Use

SAMPLE COLLECTION
Method of collection through the nose

1. The operator must hold the swab with the right hand and securely hold the patient's head with the left hand. Insert the swab towards the bottom of the nasal cavity, penetrating slowly and gently. Do not exaggerate to avoid traumatic bleeding.
2. When the tip of the swab touches the back of the nasopharyngeal cavity, let the swab remain in position for a few seconds (about 3 seconds) and gently rotate it for a full turn, then slowly remove the swab.

Method of collection through the throat

1. The patient's head should be slightly tilted and mouth open, exposing the tonsils on both sides.
2. Rub the swab on the tongue. Rub the swab on both sides of the tongue back and forth with a firm motion at least 3 times, then rub up and down the back pharyngeal wall at least 3 times.

Samples should be tested as soon as possible after collection. If it is necessary to use the viral transport tube for samples (VTM), a minimum dilution of the sample is recommended. Nasopharyngeal swabs in VTM are stable for up to 72 hours at 2-8 °C.

SAMPLE PREPARATION

1. This kit can be used for the detection of nasopharyngeal swab samples.
2. The test must be performed at room temperature (15-30 C°).
3. Sample extraction: add 12 drops (about 300ul) of the solution to the extraction tube. Insert the swab (with the detected sample) into the tube. Rotate it and rub it against the sides of the inner wall of the tube about 10 times. Allow the sample to dissolve in the solution for as long as possible and squeeze the cotton tip along the inner wall of the extraction tube.
4. Let the liquid remain in the tube for at least 1 minute. Squeeze the tube several times with your fingers from the outside to immerse the swab in the liquid.
5. Removing the swab: squeeze the head of the swab while removing the swab to remove as much liquid as possible from it. Dispose of the swabs according to regulations for the disposal of biological hazard waste.
6. Replace the dropper tip on the extraction tube.

TEST PROCEDURE
Preparation: Allow all reagents and samples to equilibrate to temperature before proceeding with the test.
Procedure:

1. Remove the cassette from the sealed package before conducting the test and place it flat on the work surface.
2. Invert the extraction tube to a vertical position and pour 2 drops (about 70-80L) of the extracted sample from the tube into the dedicated window of the cassette.
3. Check the result after 10-20 minutes. Do not interpret the result after 20 minutes.

RESULT INTERPRETATION

• NEGATIVE: the presence of a single pink line (C), and no line (T) in the results window indicates the absence of the COVID-19 antigen and therefore a negative result.
• POSITIVE: The presence of two lines in the two control areas (C) and (T) of the device indicates a positive result.
• INVALID: If the control line (C) is not visible in the results window after the test is performed, the result is considered invalid. It is recommended to retest the sample using a new test.

Packaging Type

The package includes:
   -  Test. Each test cassette is individually packaged together with a desiccant sachet
   -  Extraction tube
   -  Sterile swab
   -  Dropper tip
   -  Extraction solution
   -  Instruction leaflet

Warnings

For diagnostic in vitro use only.
Do not use the kit after the expiration date.
Do not interchange or mix components belonging to different batches.
Avoid microbial contamination of reagents.
Use the test immediately after opening it to prevent it from coming into contact with or absorbing moisture.
Technical personnel involved in the collection of samples for COVID-19 detection must have training in biosafety (qualified training) and adequate experimental skills.
If the test result is positive, the kit must be disposed of properly and according to the legislation in force in the country.
Storage
The kit can be stored at any temperature between 2-30°C. Do not freeze. The stability of the kit is ensured for 24 months if stored properly according to these conditions. The test cassette should be used within 1 hour after opening the package to prevent incorrect results due to moisture absorption.