CE FDA Fast Results COVID-19 (SARS-CoV-2) Antigen Test Kit 25pcs Packing

Antigen Test Description:

This product is used for in vitro qualitative detection of the antigen of SARS-CoV-2 in human saliva. The novel coronaviruses 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 pidemiological 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

Antigen 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 the SARS-CoV-2 antibody labeled with colloidal gold on the binding pad, and the immune complex forms a sandwich complex with another coated antibody against the SARS-CoV-2 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

Antigen Test Materials provided

1) Test device
2) Antigen extraction tube
3) Extraction Reagent
4) Instruction
5) workbench

Storage and Expiry:

Materials required but not provide:

Timer.

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

[Sample Storage]

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 Preparation]

1. Take out the extraction tube, Add 2 drops of saliva into the extraction tube.
2. Then add 6 drops (about 0.2 mL) of the extraction reagent into the extraction
tube, mix well and put it on the workbench.
3. Insert a dropper tip into the extraction tube tightly.

[Test Procedure]

Read the instructions carefully before use and bring test device,
extraction reagent and specimens were restored to room temperature.
1. Open the package and take out the test device.
2. Insert a dropper tip into the extraction tube tightly, put two drops into the
specimen well (s) of the test device, and start the timer.
3. Interpret the results within 20 minutes. Strong positive results can be reported
within 20 minutes, however, negative results must be reported after 20 minutes,
and the results after 30 minutes are no longer valid.