ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity

Rapid Test Kit Antige Self Testing Rapid Test Kit COVID-19 Antigen Detection Self Test Kit

Intend Use

• It's a qualitative detection
• specimen sample is nasal swab
• The test result can be used for early isolation of patients with suspected infection
• To be notic, the result cannot be used as only diagnosis basis of SARS-CoV-2 infection
• Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment.
• Further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative

Product Details

Product Feature

• No pre-processing required, simple operation, do not need any auxiliary equipment
• Rapid test, easy to interpret the results in 15 minutes
• Transported and stored at room temperature
• High Accuracy, Sensitivity and Specificity

Main Components

• 20 Test Cassettes
• 20 Sample tubes
• 20 Extraction Buffer
• 20 Swabs
• 1 Tube stand
• 1 Package Insert

Use Step

• Open the sealed pouch and remove the test casstette. Lay it face up on a clean, dry and flat surface.
• Unpack the sample extraction, add all of the sample extraction into the sample tube and then put the tube into tube stand.
• Gently, insert the entire absorbent tip of the swab (around 1.5 cm) into your nostril. Rotate walls of your nostril 5 times or more. Use the same swab to repeat steps in the other nostril.

• Insert the swab into the ssample tube with extraction buffer. Mix well. Mix well and squeeze the swab 10-15 times by compressing the walls of the tube against the swab. Roll the swab head against the inner wall of the tubes as you remove it.
• Close the cape 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 15-20minutes 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

FAQ

• MOQ: MOQ limit that is 10000 pieces.
• Delivery Date: After order confirmed, we will arrange your order immediately and offer you an estimated delivery date.
• Shipment: We choose Air cargo or Ocean cargo
• Is it possible to use our own packing box/specified packing box: For bulk order, the box can be customized, we will confirm design before packaging.
• How to get a quotation: Please tell us the products and quantity you need, we will offer you our best price.
• Can you design for us: We accept various OEM/ ODM orders.

Other Information

• This kit is a qualitative detection, which cannot determine the exact content of antigen.
• The test is intended for use outside the body only.
• Not to be taken internally. Avoid sample buffer contact with skin and eyes.

• Keep out of the reach of children. Any child under age 18 shouldn’t perform the test without parental guidance, or professional aid.

• Not following the exact instructions can affect the outcome of the test. The final diagnosis must be confirmed by a physician.

• Do not use the test if the packaging is damaged. Do not use broken test components.

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.