COVID-19 ANTIGEN RAPID TEST

SUMMARY

This product is used for in vitro qualitative detection of COVID-19 antigen in human throat swabs, nasal swab and saliva.

Coronavirus (CoV) is belongs to the Nestovirus, Coronaviridae, and is divided into three genera: α, β, and γ. Genera α, β are only pathogenic to mammals, genera γ mainly cause bird infection. CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through the fecal-oral route.

There are 7 types of human coronavirus (HCoV) that cause human respiratory disease: HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV-HKU1, MERS-CoV and SARS-CoV2, which are the important pathogens of human respiratory infections.

SARS-CoV2 may cause COVID-19 which first appeared in Wuhan China in November 2019. The clinical manifestations are systemic symptoms such as fever and fatigue, accompanied by dry cough and dyspnea, etc., which can rapidly develop into severe pneumonia, respiratory failure, and acute breathing Distress syndrome, septic shock, multiple organ failure, severe acid-base metabolism disorders, etc. and even life-threatening.SARS-CoV2 also named as 2019-nCoV.

PRINCIPLE

The reagent utilizes the principle of double antibody sandwich combines with colloidal gold immunochromatography.

When an appropriate amount of the test sample is added into the sample hole of the test card, the sample will be move forward along the test card under the action of capillary. If the sample contains covid-19 antigen, the antigen will bind to the colloidal gold-labeled COVID-19 antibody. The immune complex forms a sandwich complex with another coated 2019-nCoV antibody at the detection line (T line), showing that the COVID-19 antigen is positive.

The test card also contains a quality control line C, which should appear regardless of whether there is a test line. The quality control line C is the color belt of the quality control antibody immune complex. If quality control line C does not appear, it indicates that the test result is invalid, and the sample shall be retested with another test.

MATERIALS SUPPLIED

20 x Tests. Each test cassette is packed in a pouch with a package of desiccant;

20 x Extraction tubes.

20 x Sterile Swabs.

20 x Dropper Tips

1 x Extraction Buffer

1 x Instruction for use

SAMPLE REQUIREMENT

1. This kit can be used for the detection of throat swabs, nasal swabs and saliva samples.

2. The sample can be stored for 5 days at 2 ~ 8°C. Long-term preservation should be frozen below -20 °C, avoid repeated freezing and thawing. Anticoagulated whole blood samples should not be stored for more than 72 hours at room temperature and not more than 7 days at 2-8 °C.

3.The refrigerated/frozen sample should be returned to room temperature and mixed evenly before testing. When clearly visible particulate matter is present in the sample, it should be centrifuged to remove sediment before testing.

4. If the sample contains a large amount of lipid, hemolysis or turbidity, please do not use it, so as not to affect the result judgment.

5. Sample extraction: Insert swab with collected sample into extraction tube containing 200μl of sample extraction buffer. Rotate it closely to the inner wall of the test tube for about 10 times. Make the sample dissolve in the solution as far as possible and squeeze the swab’s cotton tip along the inner wall of the extraction tube. Make the liquid stay in the tube as far as possible.  Remove the swab and use extraction solution as test sample.

INTERPRETATION OF RESULT

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

A total of 114 samples from susceptible subjects were tested byCOVID-19 Antigen Rapid Test and by PCR test. Comparison for all subjects is shown in the following table.

Note: A total of 114 positive control tests have been test, Among 114 cases confirmed positive by PCR, 74 cases were positive for antigen testing, and all 74 cases were symptomatic. There were 40 negatives in antigen testing, of which 26 were asymptomatic, 10 were mildly symptomatic, and 4 were symptomatic.

Manufacturer:

Beijing North Institute of Biotechnology Co.,Ltd.

Pan Jiamiao A20, Fengtai District, Beijing 100076, China

Exportation Representative:

Eugene Biotech Co., Ltd.

Tel: 86 21 57526862

Email: info@eugenebio.com

European Authorized Representative:

Lotus NL B.V.

Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.

E-mail：peter@lotusnl.com

Tel：+31644168999