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ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity

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ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity

ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity
ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity

Large Image :  ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity

Product Details:
Place of Origin: China
Brand Name: LABNOVATION
Certification: ISO13485,ISO9001,CE
Model Number: LX-401320
Payment & Shipping Terms:
Minimum Order Quantity: 10000 Pieces
Price: Negotiation
Packaging Details: Carton
Delivery Time: 5-7 work day
Payment Terms: T/T, D/A, D/P
Supply Ability: 500000/Day

ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity

Description
Total Accuracy: 99.17% Storage Condition: 2℃-30℃
Shelf Life: 24 Months Humidity: <60%
Group: All People Format: Cassette
High Light:

COVID 19 antigen rapid detection kit

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ISO13485 antigen rapid detection kit

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rapid antigen 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

Item Value
Model Number LX-401320
Type 20 Tests/Kit
Warranty 24 Months
Power Source Instruction Manual
Quality Certification CE,MSDS
Safty Standard ISO13485,ISO9001
Smple Type Nasal Swab
Sample volume 3 Full drops
Test Speed 10 minutes < x < 15 minutes
Total Accuracy 99.17%
Sensitivity 97,45%
Specificity 100%

ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity 0
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

ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity 1
 
ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity 2
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.

ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity 3

  • 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.

ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity 4
 
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.

 
ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity 5
 
Virus Sources

Global high frequency mutation Alpha / B.1.1.7(U.K.) Beta I B.1.351(South Africa)
Gemma I P.1(Brazil) Kappa I B.1.617.1(India) Delta I B.1.617.2(India)
C.37,ect Alpha I B.1.17(U.K.) B.1.36.16.etc
A.2.5,etc A.23.1 Alpha I B.1.17(U.K.)
B.1.1.33.etc C.1.1.etc. etc.

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
ISO13485 COVID-19 Antigen Rapid Detection Kit 60% Humidity 6

Contact Details
Labnovation Technologies, Inc.

Contact Person: Ld

Tel: +8613480985156

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