Rapid Antigen Test Kit SARS-CoV-2 Antigen Rapid Diagnostic Test Professional Testing CE Certificated 20Tests/Kit

Intend Use

The Labnovation SARS-CoV-2 antigen rapid test kit is intended for the qualitative detection od SARS-COV-2 infection from patients. It is used for in vitro qualitative detection of the antigen of novel virus in human nasopharyngeal or Oropharyngeal swabs.

Product Details

Main Components

• Test Cassettes
• Sample tubes with Prefilled Sample extraction buffer
• Swabs
• Tube Stand
• Instruction for use

Analytical Results

Product Features

• High effective, Low cost
• One step operation, without extra equipment
• Rapid testing, get the result within 15 minutes
• High accuracy, sensitivity and specificity

Sample Collection

• By nasopharyngeal swab: The sampler gently holds the head of the person to be collected with one hand, holds the swab with the other hand, sticks the swab to the nostril to enter, and slowly penetrates backwards along the bottom of the lower nasal passage, so as not to exert too much force to avoid traumatic hemorrhage. When the tip of the swab reaches the posterior wall of the nasopharynx cavity, gently rotate it for several times (in case of reflex cough, stop for a minute), and then slowly take out the swab.
• By oropharyngeal swab: The head of the person to be collected is slightly tilted and his mouth is wide open, exposing the pharyngeal tonsils on both sides. Wipe the swab across the root of the tongue. Wipe the pharyngeal tonsils on both sides of the person to be collected back and forth with a little force for at least 3 times, and then wipe up and down the posterior pharyngeal wall for at least 3 times.

Test steps

1. Take a sample tube (with prefilled sample extraction solution).Remove the aluminum foil sealing of the prefilled sample extraction tube and then put the tube into the tube stand.
2. Dip the swab into the sample extraction liquid after sample collection, fully immerse the tip of the swab, rotate and squeeze the swab 10 times, then pull out the swab, and take the stranded liquid as much as possible.
3. Close the cap of the sample tube. Add 3 full drops of the mixed solution vertically into the sample well (S) of the test cassette. Read the result 15-20 minutes after adding the sample. Result got after 20 minutes is invalid.

Result Interpretation

• Positive: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

• Negative: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

• Invalid: If there is no Control line (C) or only a Test line (T) in the result window, the test did not run correctly and the results are not valid.

Virus Sources

Limitation

1. This reagent is a qualitative detection reagent, which cannot determine the exact content of antigen.

2. The test results of this reagent are only for the reference of clinicians and should not be taken as the sole basis for clinical diagnosis and treatment. Clinical management of patients should be considered in the light of their symptoms/signs, medical history, other laboratory tests and treatment responses.

3. Restricted by antigen detection reagent method, the lowest detection limit (sensitivity analysis) is generally lower than that of nucleic acid detection, so the researchers deal with negative result to give more attention, should be combined with other test results comprehensive judgment, advice to doubt the negative result of nucleic acid detection or virus isolation culture identification method for review.

4.False negative results may be caused by unreasonable sample collection, transport and treatment, and low viral load in samples.

Certificate

Labnovation Technologies, Inc. is an original manufacturer established in Shenzhen, China since 2001. We are dedicated in developing and manufacturing IVD instruments and reagents including HbA1c analyzer and reagents, rapid test reader & reagents, hematology reagents, clinical chemistry reagents, electrolyte reagents, wash solution and urine test reagents.
 

Labnovation products are developed in house, tested extensively in clinics and passed strict quality controls. All of our products are CE marked and approved by SFDA. In the past 15 years, our products have been exported to 110 different countries and used in 8000 hospitals worldwide. We provide both ready-to-use final products and bulk OEM reagents, including ready-to-use reagents, concentrated, and powder.

With an investment of 10% of our annual sales into R&D, we release new products every years. We win more and more domestic and international cooperation by company reputation and products quality while we actively take part in fairs like MEDICA,AACC, ARBA HEALTH and so on through which we are well-known by the companies in this field.