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COVID-19 Ag Rapid Test KitiClean COVID-19 Antigen Rapid Test Kit (25pcs): Saliva Test
COVID-19 Ag Rapid Test KitiClean COVID-19 Antigen Rapid Test Kit (25pcs): Saliva Test
iClean COVID-19 Antigen Rapid Test Kit (25pcs): Saliva Test
iClean COVID-19 Antigen Rapid Test Kit (25pcs): Saliva Test

iClean COVID-19 Antigen Rapid Test Kit (25pcs): Saliva Test

iClean 2019-nCoV Ag Rapid Test Kit

The COVID-19 antigen rapid test kit is designed to identify the SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of infection.

Saliva-based tests are especially convenient compared to nasal or oropharyngeal swabs making it easier for people to self-test.

Contains: saliva collection funnel *20, extraction buffer *20, test cassette *20

Specimen types: saliva

Testing time: 10-15 minutes

PRODUCT DETAIL
INQUIRY

The COVID-19 Antigen Test is an in vitro immunochromatographic method for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from the saliva of individuals suspected of COVID-19.

Description of iClean COVID-19 Antigen Rapid Test Kit

The test area (T) on the plain film has been pre-coated with an anti-2019-nCoV monoclonal antibody, forming a red reaction line in the area (T). If the sample does not contain the 2019-nCoV antigen, a red reaction line cannot be formed in the T zone.

A positive test result indicates the presence of viral antigens, but the correlation of clinical, medical history, and other diagnostic information is necessary to determine infection status. However, bacterial infection or co-infection with other viruses can also cause a positive test result.

Sensitivity: 96.15%
Specificity: 99.78%
CE marked
CE REGISTRATION

How to Use 2019-nCoV Ag Rapid Test Kit

1 ➜2 ➜3 ➜4 ➜5 ➜

Remove the cap of the extraction buffer

Connect the saliva collector to the extraction buffer tube

Cough deeply three times, and spit out saliva from the back of the oropharynx to the collector, saliva volume is up to the line

Remove the saliva collector

Return the cap
6 ➜7 ➜8 ➜9 ➜10

Shake the tube at least 1 min to mix the saliva and extraction buffer thoroughly

Break the pin on the top

Add 3~4 drops of the processed sample solution (about 80 μL) into the sample well

Wait 10-15 minutes

View the results

NOTE:

  • Clean your hands before touching the tool.
  • Do not eat for 30 minutes before collection.
  • Rinse your mouth with water 30 minutes before saliva collection to clean up the residue.
  • Pressing your tongue against the bases of your upper and lower teeth will help you spit out a sufficient amount of saliva in a short amount of time.
  • The amount of saliva collected must reach the calibration line.
  • Used collection tools should be disposed of in the dedicated clinical waste bin.

Interpretation of the Test Results

Positive Result:

If both C and T lines are visible within 15 minutes, the test result is positive and valid.

Negative Result:

If the test area (T line) has no color and the control area displays a colored line, the result is negative and valid.

Invalid Result:

The test result is invalid if a colored line does not form in the control region. The sample must be re-tested, using a new test cassette.

NOTE:

  • After the test kit is opened, the test should be carried out within 60 minutes.
  • Read the result after 15 minutes. The interpretation is invalid for more than 30 minutes.
  • When invalid results are presented, you should re-test with a COVID-19 antigen rapid test kit.

Cautions for Using iClean COVID Ag Rapid Test Kit

  • Since it cannot be ruled out that the patient is simply infected with the new coronavirus, a negative test result should be considered a presumptive result. The COVID-19 antigen rapid test kit cannot be used as the sole basis for treatment, patient management and infection control. A negative result should be considered based on the patient’s recent exposure, past medical history, and clinical signs and symptoms consistent with COVID-19. If necessary, it should be confirmed by molecular testing in patient management.
  • This iclean covid test kit is only used for in vitro auxiliary diagnosis and should be used strictly by the Instructions For Use.
  • Please check the expiry date and packaging integrity of the kit before use. If the packaging of the test equipment is damaged or the product is out of date, it cannot be used.
  • Due to the limitations of antigen detection kits, it is recommended to use nucleic acid amplification or virus culture identification methods to review and confirm negative test results.
  • The kit is stored at 4℃~30℃. Keep away from moist, sunlight, heat, or freezing conditions.
  • The test results of this kit are for clinical reference only, and clinical diagnosis should be considered in combination with the patient’s symptoms, signs, medical history, other laboratory tests and treatment response.
  • The test results of this COVID-19 antigen rapid test kit are only for clinical reference, and the clinical diagnosis of the disease should be considered in combination with the patient’s symptoms, signs, medical history, other laboratory tests, and treatment response.

Adhering to the principle of “first-class products, first-class service”, Huachenyang (Shenzhen) Technology Co., Ltd. takes product quality as the foundation of enterprise development, specializes in the production of flocking swabs, throat swabs, oral swabs, nasal swabs, cervical swabs, sponge swabs, virus sampling tubes, virus preservation liquid, etc.
With more than 14 years of manufacturing experience in the field of medical consumables, HCY organizes production and manages sales in strict accordance with ISO9001 and ISO13485 and has certain advantages in the industry.

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