The COVID-19 Antigen Detection Kit is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibody against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates absorbed in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 antigen is present in the sample, the complex of the anti-SARS-CoV-2 conjugate and the virus will be captured by the specific anti-SARS-CoV-2 monoclonal antibodies coated on the test line region (T). Absence of the T line suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking effect has occurred.

 

PRODUCT FEATURE

  • Novel Coronavirus Antigen Detection;
  • Using Sputum Sample;
  • Fast Detection: Result in 15 minutes;
  • High Accuracy;
  • Easy to Use.

 

COMPONENTS - 25PCS/BOX

  • Test Card * 25;
  • Sample Extraction Tube * 25;
  • Sample Collector* 25;
  • Specimen Bag* 25;
  • Cotton swab
  • Package Insert * 1.
     

STORAGE & STABILITY

  • Store the product package at temperature 2-30°C or 38-86°F, and avoid exposure to sunlight. The kit is stable within the expiration date printed on the labeling.
  • Once an aluminum foil pouch is opened, the test card inside should be used within one hour. Prolonged exposure to hot and humid environment may cause inaccurate results.
  • The lot number and the expiration date are printed on the labeling.

 

WARNINGS & PRECAUTIONS

  • Read the instructions for use carefully before using this product.
  • This product is for professional use ONLY.
  • This product is applicable to nasopharyngeal swab and sputum Using other sample types may cause inaccurate or invalid test results.
  • Sputum rather than saliva is the type of sample recommended by WHO. Sputum comes from the respiratory tract while saliva comes from the mouth.
  • If sputum samples cannot be obtained from patients, nasopharyngeal swab samples should be used for testing.
  • Please make sure that a proper amount of sample is added for testing. Too much or too little sample amount may cause inaccurate results.
  • If the test line or control line is out of the test window, do not use the test card. The test result is invalid and retest the sample with another one.
  • This product is disposable. DO NOT recycle used components.
  • Dispose of used products, samples, and other consumables as medical wastes under relevant regulations.

 

MINIMUM ORDER QUANTITY:

  • 100 kits (2500 tests).
  • For an order of 100+ kits (2500+ tests) please email us (hello@tradepharma.network).

 

DOCUMENTATION (AVAILABLE UPON REQUEST):

EC Certification - Declaration of Conformity;

MHRA Registration Letter;

ISO 13485 Certification;

Certification for Safe Transport;

Import & Export Qualification;

Certificate of Free Sale.


Ready to ship (from Belgium).

COVID-19 Antigen Detection Kit for Nasopharyngeal Swab/Sputum Samples - 100 Kits

€7,500.00Price