Professional Use COVID-19 Ag Rapid Test Kit: CE Marked

The professional use COVID-19 Ag rapid test kit is designed to assist in the rapid diagnosis of SARS-COV-2 infection by detecting novel Coronavirus antigens in nasopharyngeal and oropharyngeal swabs using the dual-antibody sandwich method.

CE Certified COVID-19 Ag Rapid Test Kit

According to the EU IVDD (98/79/EC) In Vitro Diagnostic Devices Directive, Professional Use COVID-19 Ag Rapid Test Kit belongs to other category and Huachenyang has provided a Self-Declaration (Doc) for the product.

In addition, we also sell Self-test COVID-19 Ag Rapid Test Kit (Colloidal Gold), and the product has been awarded CE2934 certificate after a strict technical examination, which belongs to the Self-Test category.

Description of COVID-19 Ag Rapid Test Kit

This test is limited to laboratories that are certified to perform medium, high complexity, or exempt complexity testing requirements. The test is authorized for use at Point of Care (POC), which are inpatient care facilities that have received CLIA exemption certificate, compliance certificate, or certification certificate. The test is to identify the SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of infection. A positive test result indicates the presence of viral antigens, but the correlation of clinical, medical history and other diagnostic information is necessary to determine infection status. However, bacterial infection or co-infection with other viruses can also cause a positive test result.

The test area (T) on theplain film has been pre-coated with an anti-2019-nCoV monoclonal antibody, forming a red reaction line in thearea (T). If the sample does not contain the 2019-nCoV antigen, a red reaction line cannot be formed in the T zone.

Sensitivity: 96.15%

Specificity: 99.78%

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 suspected patients with symptoms, mild symptoms, or even asymptomatic patients, and also for those in close contact with infected persons and those under isolation and observation.

How to Use COVID-19 Ag Rapid Test Kit?

Collection of nasopharyngeal or oropharyngeal samples

1. After cleaning your hands, remove the nasopharyngeal swab and COVID-19 antigen test kit from the aluminum foil pouch.
2. Insert the nasopharyngeal swab into the nasopharynx, or insert the oropharyngeal swab into the oropharynx, gently rotate it 5 times and slowly remove it.

Extract Sample

1. Immediately after collecting the specimen, the swab was immersed in the sample extraction buffer.
2. The swab was repeatedly swirled against the wall of the tube for 10 seconds, then the swab was squeezed several times by holding the semi-solid tube with the fingers, and then the swab was slowly removed from the tube.
3. After removing and discarding the swab in the bio-waste container, tightly cap the sample extraction buffer, and then gently shake the pipette to mix the liquid in it.

Test Procedure

1. Invert the specimen extraction tube and hold it upright, squeeze the tube, and add more than 3 drops of sample solution (about 70-90 μL) to the test box through the nozzle of the tube.
2. Read the results after 15 minutes. The results after 30 minutes are invalid.

Interpretation of the Test Results

Positive: Both “T” and “C” sites have visible color lines.

Negative: Only the “C” site has color, “T” does not.

Invalid: If no color appears at the “C” site, the test result is invalid and the sample needs to be retested.

Limitations of Professional Use COVID-19 Ag Rapid Test Kit

1. This 2019-nCoV Ag rapid test kit is for the direct detection of the presence of SARS-CoV-2 antigen in respiratory specimens from patients suspected of covid-19.
2. This kit is a qualitative analysis, not a quantitative analysis.
3. The accuracy of the test depends on the sample collection process. Improper sample collection and storage can affect the test results.
4. The test results of this kit are for clinical reference only. A definitive diagnosis should only be made after all clinical and laboratory test results have been evaluated.
5. Due to the limitations of the antigen detection kit, it is recommended that negative test results be reviewed and confirmed using nucleic acid amplification or viral culture identification methods.
6. Positive test results do not exclude co-infection with other pathogens.

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

1. The test results of this kit are for clinical reference only. A definitive diagnosis should only be made after all clinical and laboratory test results have been evaluated. 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.
2. COVID-19 Antigen Test Kit(Lateral Chromatography) is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures and proper infection control procedures and individuals similarly trained in point of care settings.
3. This kit is for the direct detection of the presence of SARS-CoV-2 antigen in respiratory specimens from patients suspected of covid-19.
4. This COVID-19 Ag rapid test kit is a qualitative analysis, not a quantitative analysis.
5. The accuracy of the test depends on the sample collection process. Improper sample collection and storage can affect the test results.
6. Due to the limitations of the antigen detection kit, it is recommended that negative test results be reviewed and confirmed using nucleic acid amplification or viral culture identification methods.
7. Positive test results do not exclude co-infection with other pathogens.