Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) Instruction for Use

[Product name]

Novel Coronavirus (COVID-19) Antigen Test Kit

(Colloidal Gold)

[ Package Type]

25 tests/ box

[Intended use]

This product is a lateral flow immunoassay intended for the qualitative detection of COVID-19 antigen in direct

nasopharyngeal or oropharyngeal swabs from suspected individuals with COVID-19 infection by their healthcare provider within the first seven days of symptom onset.

[Components]

Each kit includes test card and dilution buffer. Test card is packed in aluminum foil bag and dilution buffer is in individual tube. The test card comprises plastic card and

reagent strip. The reagent strip comprises PVC pad, sample pad, conjugate pad, nitrocellulose membrane and absorbent pad.

[Storage and validity]

This kit shall be stored at 4℃-30℃,with a validity period of 12 months. After the aluminum foil bag is opened, it should be used within 15 minutes.

[Sample requirements]

The kit can be used for the detection in nasopharyngeal swabs, oropharyngeal (throat) swabs, bronchoalveolar lavage (BAL) fluid. Specimens should be collected,

transported and stored according to standard procedures.

[Instructions for sample collection ]

1. When collecting the specimen of nasopharyngeal swabs, oropharyngeal (throat) swabs, please follow the collection guidelines according to your organization or refer to the

CDC website for additional information:https://www.cdc.gov/coronavirus/2019-nCoV/lab/guideline s-clinical-specimens.html .

2. After collection, please remove the seal from the top of the buffer vial containing the extraction buffer.

3. Place and soak the patient swab in the extraction buffer for 10 seconds and then stir well by rotating the swab against the side of the vial 5 times.

4. Remove the patient swab while squeezing the middle of the extraction vial to remove the liquid from the swab.

5. Discard the swab in biohazard waste.

[Testing procedure]

1.Read the instruction carefully before using the test kit and restore the test kit and sample to room temperature.

2.Take out the test card from the foil bag, put it on the level table and mark it;

3.Add 80μl sample from the sample buffer into the sample well of the card with dispette or pipette, start timing;

4.Wait for 1-20 minutes until the test line appear as red and record the result as a positive. If the test line does not appear as red at 20 minutes, it is recorded as a negative.

[Interpretation of test results]

Positive：C line appears red, T line appears red, which

indicates the COVID-19 antigen in the sample is detected.

Negative: C line appears red, T line does not appears red,

which indicates the COVID-19 antigen in the sample is not

detected.

Invalid：C line does not appear red.

[Contact Information]

Changzhou Biowin Pharmaceutical Co., Ltd.

Add:Building 3,Caltech Port,218 Fumin Road , Changzhou

Economic Development Zone,Changzhou, China

Phone / Fax: (0519) 88404626

[Release and approval date of the instruction]