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