Rapid Antigen Test Kit COVID-19 Antigen Rapid Test Kit High Quality Simple Operate Professional Use Rapid Antigen Test Kit

Intend Use

This rapid test kit is intended for the qualitative detection of SARS-CoV-2 infection from patients. It is for professional use only. It is an aid in the diagnosis of the patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and results of other laboratory tests. Results from this test kit should not be used as the sole basis for diagnosis.

Product Details

Product Advantage

• Simplicity: It is extremely easy to use with simple to understand instructions.
• Fast: After the extraction of the sample, it will take just 10-15 mins for the result to be reflected on the testing device.
• Reliable: CE, ISO13485 Certificated, Stric quality control, High quality
• Extraction tube is fully enclosed for disposal

Main Components

• 20 Test Cassettes
• 20 Sample tubes
• 2 Sample extraction buffers
• 20 Swabs
• 1 Package Insert

Use Step

• Add 550μL sample extraction (about 22-24 drops) into the sample tube.
• Insert the swab into the sample tube prefilled with extraction buffer. Mix well and squeeze the swab 10-15 times by compressing the wall s of the tube against the swab.
• Roll the swab head against the inner wall of the tubes as you remove it. Try to release as much liquid as possibe. Dispose of the used swab in accordance with your biohazard waste disposal protocol.
• 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.

Result Interpretation

• POSITIVE: Two (2) distinct colored lines appear. One line should be in the control region (C) and the other line should be in the test region (T).

• NEGATIVE: One (1) colored line appears in the control region(C). No apparent colored line appears in the test region (T).

• INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure.

Virus Sources

Certificate

Application

• Suspected population(Families and close contacts of confirmed or suspected cases)
• High-risk groups(the elderly and children with basic illness or people with poor immunity)
• Center for Disease Control and Prevention
• Primary Health Care Institution

Limitations

• This reagent is a qualitative detection reagent, which cannot determine the exact content of antigen.
• 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.
• 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.
• False negative results may be caused by unreasonable sample collection, transport and treatment, and low viral load in samples.

FAQ

• MOQ is ?

We have the MOQ limit, which is 10000 pieces.

• What the certification you have?

CE, ISO9001, ISO13485

• Delivery date?

After order confirmed, we will arrange your order immediately, and offer you an estimated delivery date.

• Accept OEM/ODM?

Yes, we accept OEM / ODM.

• Shipment?

Air cargo or Ocean cargo.

• Payment Method

Business to business account.

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.