COVID -19 New Coronavirus IgG / IgM Rapid Test Cassette ISO13485 / CE

Product Name: COVID-19 New Coronavirus IgG/IgM rapid screen Test Cassette

Accessories: Instruction for use, buffer, pipette

Intended Use:

The COVID-19 IgM/IgG Test is used for qualitative detection of novel coronavirus IGM/IGG antibodies in human serum, plasma and whole blood. After infection with the novel coronavirus, the common signs include respiratory symptoms, fever, cough, wheezing and dyspnea, etc. In more severe cases, the infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure and even death. Coronaviruses can be expelled from the body through respiratory secretions, transmitted by oral fluids, sneezing, contact, and by airborne droplets.

TEST PRINCIPLE

The COVID-19 (Sars-CoV-2) IgM/IgG Test is the colloidal gold labeled rabbit IgG and the novel coronavirus (Sars-CoV-2) antigen, while the nitrocellulose membrane is coated with anti-human IgG and sheep anti-rabbit IgG combined to form a band. The principle of colloidal gold immunochromatography indirect method is used to detect the novel coronavirus (Sars-CoV-2) IgM/IgG antibody in human serum.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready

to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid

cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is

significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive: Two red lines are visible in the result window. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result.

Negative: The control line appears in the result window, but the test line is not visible.

Invalid: If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.