Labnovation Technologies, Inc.

Labnovation Technologies,Inc.

Manufacturer from China
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ISO9001 Rapid Test Device Nasopharyngeal SARS-CoV-2 Antigen Detection Kit

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Labnovation Technologies, Inc.
City:shenzhen
Country/Region:china
Contact Person:MissAimee li
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ISO9001 Rapid Test Device Nasopharyngeal SARS-CoV-2 Antigen Detection Kit

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Brand Name :LABNOVATION
Model Number :LX-401301
Certification :ISO13485,ISO9001,CE
Place of Origin :China
MOQ :10000 Pieces
Price :Negotiation
Payment Terms :T/T, D/A, D/P
Supply Ability :500000/Day
Delivery Time :5-7 work day
Packaging Details :Carton
Test Time :<15 min
Storage Condition :2℃-30℃
Group :All People
Specimen :Nasopharyngeal Swab Or Oropharyngeal swabs
Quanlity Guarantee Period :24 months
Package :20 Tests/Kit
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Rapid Antigen Test Kit SARS-CoV-2 Antigen Rapid Test Kit 20Tests/Kit For Professional Detection Use Rapid Test Kit

Intend Use
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 infection from patients. The test provides preliminary test results. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other management decision.


Product Details

Item Value
Model Number LX-401301
Type 20 Tests/Kit
Specificity 100%
Sensitivity 98.04%
Accuracy 99.60%
Warranty 24 Months
Quality Certification CE,MSDS
Safty Standard ISO13485, ISO9001
Test Speed <15 minutes
Sample Type Nasopharyngeal or Oropharyngeal

Sample Volum

3 Drops


ISO9001 Rapid Test Device Nasopharyngeal SARS-CoV-2 Antigen Detection Kit

Main Components

  • Test Cassettes
  • Sample tubes
  • Sample extraction buffer
  • Swabs
  • Instruction for use

ISO9001 Rapid Test Device Nasopharyngeal SARS-CoV-2 Antigen Detection Kit

Product Features

  • Quick Testing Speed, Read the result in 15 minutes
  • Easy for use without extra instrument
  • CE Certificated , ISO13485,ISO9001 Certificated

ISO9001 Rapid Test Device Nasopharyngeal SARS-CoV-2 Antigen Detection Kit

Other Information

  • For IN VITRO diagnostic use only.
  • Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.
  • The test device should remain in the sealed pouches until use. If sealing problem happens, do not test. Don’t use after the expiration date.
  • All specimens and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.

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.

ISO9001 Rapid Test Device Nasopharyngeal SARS-CoV-2 Antigen Detection Kit

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.


ISO9001 Rapid Test Device Nasopharyngeal SARS-CoV-2 Antigen Detection Kit

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.


Certificate
ISO9001 Rapid Test Device Nasopharyngeal SARS-CoV-2 Antigen Detection Kit

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