Self-test COVID-19 Ag Rapid Test Kit (Colloidal Gold): CE Marked

The COVID-19 Ag Rapid Test Kit (Colloidal Gold) uses the double antibody sandwich method to legally detect the novel coronavirus antigen in nasopharyngeal swabs or oropharyngeal swabs. It is designed to assist in the rapid diagnosis of SARS-COV-2 infection.

CE 2934 & Thai FDA Certified COVID-19 Ag Rapid Test Kit (Colloidal Gold)

HCY’s COVID-19 Ag rapid test kit (colloidal gold) belongs to the self-test category according to the IVDD (98/79/EC) in vitro diagnostic device directive. The CE 2934 certificate was obtained only after Notify Body, which meets the EU requirements, intervened to conduct a strict technical review and test on our products and proved that the covid-19 antigen rapid test kits are safe, clinically reliable, and in compliance with international technical specifications.

Description of Self-Test COVID-19 Ag Rapid Test Kit

The self-test COVID-19 Ag rapid test kit is to identify SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of infection.

The detection area (T) on the plain film is pre-coated with an anti-2019-nCoV monoclonal antibody, and finally, a red reaction line is formed in the T area. If the sample does not contain the 2019-nCoV antigen, a red reaction line cannot be formed in the T zone.

• Sensitivity: 96.15% (100/104), confirmed positive cases compared to the nucleic acid amplification test.
• Specificity: 99.78% (448/449), confirmed negative cases compared to the nucleic acid amplification test.
• Cross-reactivity: There is no cross-reactivity with influenza A virus, influenza B virus, adenovirus, Coxsackie virus, ECHO virus, and enterovirus; no cross-reactivity with Chlamydia pneumoniae, Mycoplasma pneumoniae, Chlamydia psittaci, and Chlamydia trachomatis; no cross-reactivity with Acinetobacter baumannii, Bordetella pertussis, Candida albicans, Escherichia coli, Haemophilus influenzae and Neisseria gonorrhea.

Application: 

For suspicious patients with symptoms, mild symptoms, or even without symptoms, also for testing people with close contact with infected patients and people under quarantine control.

How to Use 2019-nCoV Ag Rapid Test Kit?

Read the instruction for use carefully before performing the test.

Set Up for the Test

1. Remove one extraction tube and one COVID-19 Antigen Test Kit(Lateral Chromatography) cassette from its foil pouch immediately before testing.
2. Label the test kit and the extraction tube for each specimen to be tested.
3. Place the labeled extraction tube(s) in a rack in the designated area of the workspace.

Nasal Swab Specimen Collection

When taking a nasopharyngeal swab sample, carefully insert the flocked swab into the nostril where the most secretions are observed with the naked eye. Gently rotate and push the swab to the point of resistance at the turbinate bone (approx. 2.0-2.5cm or 1 inch near the nostril), then roll the swab on the nasal wall approximately five times before removal.

Sample Preparation

1. After the nasopharyngeal specimen collection is done, immediately immerse the swab into the sample extraction buffer.
2. To make the sample extract completely, permeated into the buffer from the swab, rotate the swab against the tube wall repeatedly for 10 seconds, and then use fingers to hold the tube to squeeze the swab several times while slowly removing the swab out of the tube. (The purpose of swab squeezing against the tube wall is important because it can keep the specimen containing liquid to remain in the tube as much as possible, and the tube wall is semi-solid.)
3. After taking out the swab and discarding it into a biohazard waste container, put on a nozzle (supplied in the kit) to the top of the extraction tube tightly and gently shake the tube to mix the inside liquid well.

Test Procedure

1. Reverse the specimen extraction tube and keep it upright. Squeeze the test tube, and add more than 3 drops of the specimen liquid (about 70-90 μL) into the covid-19 test cassette through the test tube nozzle. 
2. Start the timer and read the result visually after 15 minutes. Do not interpret the result after 30 minutes.

Interpretation of the Test Results

Positive: Visible lines of color appear at both the T and C sites, or if the test T site shows a darker color.

Negative: Only the C reference has color, and the T position is blank.

Invalid: If C is empty and no color appears, the test result is invalid, so the sample needs to be tested again.

Limitations of Self-test COVID-19 Ag Rapid Test Kit

1. The test kit is used to directly detect the presence of SARS-CoV-2 antigen in respiratory specimens from patients suspected of covid-19.
2. This test kit is a qualitative assay, not a quantitative assay.
3. The accuracy of the test depends on the sample collection process. Improper sample collection and improper sample storage will affect the test result.
4. The results of this COVID-19 antigen rapid test kit are only intended for clinical reference. A confirmed diagnosis should only be made after all clinical, and laboratory findings have been evaluated.
5. Positive test results do not rule out co-infections with other pathogens.
6. Since it cannot be ruled out that the subject is only infected with SARS-CoV-2, a negative test result should be regarded as a presumed result. It cannot be used as the only basis for treatment, patient management, and infection control. Negative test results should be considered based on the patient’s recent exposure history, medical history, and clinical signs and symptoms consistent with COVID-19. They should be confirmed by molecular testing for patient management if necessary.

A negative result of this test kit can be caused by:

• Improper sample collection, improper sample transfer, or handing.
• The level of the SARS-CoV-2 virus is below the detection limit of the test.
• Variations in viral genes that may have caused changes in antigen determinants.

Precautions for 2019-nCoV Ag Rapid Self-Test Kit

• This kit is only used for in vitro auxiliary diagnosis and should be used strictly by the Instructions For Use.
• Please check the kit’s effective date and package integrity before use. The test equipment cannot be used if its packaging is damaged or the product is outdated.
• The time for testing and results reading must be followed.
• After the pouch of the test cassette is opened, the test should be performed within 60 min. The test cassette can only be used once.
• The kit is stored at 4℃~30℃. Keep away from moist, sunlight, heat, or freezing conditions.
• The test results of this kit are only for clinical reference, and the clinical diagnosis of the disease should be considered in combination with the patient’s symptoms, signs, medical history, other laboratory tests, and treatment response.