COVID-19 Antigen Rapid Test

COVID-19 Antigen Rapid Test-nasophary Ngeal Swab-throat Swab

[SPECIMEN]

Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of improper specimen handling and/or transport may yield false results; therefore, training in specimen collection is highly recommended due to the importance of specimen quality to obtain accurate test results.

Acceptable specimen type for testing is a direct swab specimen or a swab in viral transport media (VTM) without denaturing agents. Use freshly collected direct swab specimens for best test performance.

Prepare the extraction tube according to the Test Procedure and use the swab provided in the kit for specimen collection.

[PRINCIPLE]

The COVID-19 Antigen Rapid Test is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains a conjugate formed by binding to a monoclonal antibody against SARS-CoV-2 nucleocapsid protein;the reaction membrane contains the secondary antibodies for Nucleocapsid protein protein of SARS-CoV-2. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates dried in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 antigen presents in the sample, a complex formed between the anti-SARS-2 conjugate and the virus will be captured by the specific anti-SARS-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 has occurred.

[WARNINGS AND PRECAUTIONS]

· For in vitro diagnostic use only.

· For healthcare professionals and individuals trained in point of care settings.

· Do not use this product as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status of COVID-19.

· Do not use this product after the expiration date.

· Please read all the information in this leaflet before performing the test.

· The test cassette should remain in the sealed pouch until use.

· All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

· The used test cassette should be discarded according to federal, state and local regulations.

Nasopharyngeal Swab Specimen Collection step

  1. Remove the swab from the package.

   2. Tilt patient's head back about 70°.

   3. Insert the swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. (Swab should reach depth equal to distance from nostrils to outer opening of the ear.) Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions.
  4.  Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the tip of swab is saturated with fluid from the first collection. If a deviated septum or blockage creates difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.

   packing list : 

   1pc /box ,40.5*43.5*36.5cm , 200pcs/carton
 

   25pcs/box , 40*50*43cm, 40boxes/carton ,1000pcs/carton