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.
- 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 (email@example.com).
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
- 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