COVID19-F02BG COVID-19 antigen Test(Oral)

Intended use

This product is used for in vitro qualitative detection of the antigen of SARS-CoV-2 in human saliva specimen.

The novel coronavirus belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main Manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Test principle

This kit uses the double antibody-sandwich method to detect SARS-CoV-2 antigens. When an appropriate amount of specimen is added to the specimen well(s) of the test device, the specimen will move forward along the test device. If the specimen contains an antigen, the antigen binds to mouse anti- SARS-CoV-2 N protein monoclonal antibody labeled with colloidal gold on the binding pad, and the immune complex forms a sandwich complex with another coated mouse anti- SARS-CoV-2 N protein monoclonal antibody which was coated on the test line, a visible colored line will show up, which indicates that the SARS-CoV-2 antigen is positive. The test device also contains a quality control line, regardless of whether there is a test line, the red quality control line should appear. If the quality control line does not appear, it indicates that the test result is invalid and need to do the test again.

Warnings and Precautions

1. 1. Read the instructions carefully before using the kit, and strictly control the reaction time. If you do not follow the instructions, you will get inaccurate results.
2. 2. Do Not eat, drink, chew gum, smoke or vape for at least 30 minutes before collecting saliva.
3. 3. Guard against moisture, do not open the aluminum platinum bag before it is ready for testing. Do not use it if the aluminum foil bag is damaged or the test device is damp.
4. 4. Please use it within the validity period.
5. 5. Balance all reagents and specimens to room temperature (15 ~ 30 ℃) before use.
6. 6. Do not replace the components in this kit with components in other kits.
7. 7. Do not dilute the specimen when testing, otherwise you may get inaccurate results.
8. 8. The kit shall be stored in strict accordance with the conditions specified in this manual. Please do not store the kit under freezing conditions.
9. 9. The test methods and results must be interpreted in strict accordance with this specification.
10. 10. Negative results may occur if the SARS-CoV-2 antigen titer in the specimen falls below the minimum detection limit of this kit.
11. 11.If the extraction reagent is individual packing and one piece per test device, the batch number, expiration date and other information cannot be marked separately due to the space is limited, but those information will be consistent with the corresponding test kit.

Materials provided

1. 1) Saliva Collection Container
2. 2) Antigen Extraction Tube (Contains Extraction Reagent)
3. 3) Dropper
4. 4) Test Device
5. 5) Instruction
6. 6) Tube Rack (Except for individual package)

Storage conditions & period of validity

1. 1. Store at 4℃~30℃, and it is valid for 24 months.
2. 2. After the aluminum foil bag is unsealed, the test device should be used as soon as possible and within one hour.

Sample Transport and Storage

After specimens were collected, specimens can be stored in extraction reagent provided with the kit.

Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection. Specimen collected may be stored at 2-8℃ for no more than 24 hours; Store at -70 ℃ for a long time, but avoid repeated freeze-thaw cycles.

Specimen Collection and Preparation

1. 1.Before collecting oral fluid relax your cheeks and gently massage cheeks with fingers for15-30s.
2. 2.Gently spit oral fluid into collection container, try to collect oral fluid without bubbles.
3. 3.Tear off the sealing film on the antigen extraction tube.
4. 4.Use a dropper to draw the oral fluid and transfer 2-3 drops of oral fluid to the antigen extraction tube.
5. 5.Insert a dropper tip into the extraction tube tightly.
6. 6.Gently shake the extraction bottle for 10 seconds, to make sure the sample is well mixed.

Test Procedure

Read the instructions carefully before use and allow test device, extraction reagent and specimens to equilibrate to room temperature prior to testing.

1. Open the package and take out the test device.

2. Hold the extraction tube vertically and add two drops of the test specimens into the specimen well (s). Start the timer.

3. Interpret the results within 20 minutes. Strong positive results can be reported within 20 minutes, however, negative results must be read after 20 minutes, and the results after 30 minutes are no longer valid.

Negative result: if there is only a quality control line C, the detection line T is colorless, indicating that SARS-CoV-2 antigen has not been detected and the result is negative.

Positive result: if both the quality control line C and the detection line T appear, indicating that SARS-CoV-2 antigen has been detected and the result is positive.

Invalid result: if the quality control line C is not observed, it will be invalid regardless of whether there is detection line T (as shown in the figure below), and the test shall be conducted again.