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

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

 

COMPONENTS - 25PCS/BOX

  • 1. Test Card * 25;
  • 2. Sample Extraction Tube * 25;
  • 3. Sample Collector* 25;
  • 4. Specimen Bag* 25;
  • 5. 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 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;
  • 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 Sputum Samples (Saliva Ag Test) - 100 Kits

€7,250.00Price
    • For patients suspected of current COVID-19 infection
    • Rapid answers for patients: test results in 15–20 minutes
    • Reliable, high performance: Sensitivity*: 93.3% (98.2% for samples with Ct values ≤33) ; Specificity*: 99.4%
    • Deploy at point of care in a variety of settings
    • Accessible solution enables large-scale testing

    *Sensitivity & Specificity vs PCR using Nasopharyngeal swabs