COVID-19, PPE

Boson Biotech Rapid SARS-CoV-2 Antigen Test Card

Boson Rapid Antigen Test Kit

Accurate, efficient and trusted COVID-19 Rapid Antigen Testing Device intended to be used by trained clinical laboratory personnel.

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Intended Use

Rapid SARS-CoV-2 Antigen Test Card is a lateral flow immunoassay intended for the comparative detection of nucleocapsid protein from SARS-CoV-2 in nasal swab specimens. Samples are to be collected within 7 days of symptom onset by professional Point of Care healthcare providers in response to individuals reporting suspected symptoms of COVID-19.

Product Information

Quantity: 20 Tests/Kit
Sample Type: Nasopharyngeal Swab
Storage Temperature: 2-30°C
Shelf Life: 18 Months
Detection Method: Colloidal Gold
Test Time: 15-20 Minutes (Do not read results after 20 minutes)

Product Contents

20 Rapid SARS-CoV-2 Antigen Test Cards (Individually Packaged)
20 Sterilized Swabs (Individually Packaged)
20 Extraction Tubes (Individually Packaged)
2 Sample Extraction Buffer, 4 MLac
1 Tube Rack (6 Tubes/Rack)
1 Instruction Card

Product Features

High Accuracy

Straight forward nasopharyngeal swab collection with clinically proven high accuracy results

Affordability

Any qualified Health Care professionals can use our three-step, cost-effective portable testing kit

Easy to Use

Testing can be easily administered in almost any environment without additional special equipment. Easy to transport with no special storage requirements.

Rapid Result

Compare to standard RT-PCR tests which could take multiple days for patients to receive their results, Boson Antigen testers will show results within 15-20 minutes.

How to Use the Boson Rapid SARS-CoV-2 Antigen Test

SPECIMEN COLLECTION

Proper specimen collection, storage, and transport are critical to the performance of this test. Specimens should be tested as soon as possible after collection. Training in specimen collection is highly recommended because of the importance of specimen quality. Use only the swabs included with the kit.

  1. Carefully insert the swab into the nostril of the patient, reaching the surface of the posterior nasopharynx that presents the most secretion.
  2. Swab over the surface of the posterior nasopharynx. Rotate the swab several times.
  3. Withdraw the swab from the nasal cavity.

SPECIMEN PREPARATION

  1. Add 8 drops (about 0.25 mL) of extraction buffer into the extraction tube.
  2. Place the swab with the specimen into the extraction tube. Roll the swab three to five (3-5) times. Leave the swab in the extraction buffer for 1 minute.
  3. Pinch the extraction tube with your fingers and remove the solution from the swab as much as possible. Dispose of the used swab in accordance with your biohazard waste disposal protocol.
  4. Install the nozzle cap onto the sample extraction tube tightly. Use an extraction solution as a test specimen.

PROCEDURE

  1. Bring the kit components to room temperature before testing.
  2. Open the pouch and remove the card. Once opened, the test card must be used within 1 hour. Label the test card with the patient’s identity.
  3. Invert the extraction tube and add 2-3 drops (50-75 mL) of test specimen into the specimen well (S) by gently squeezing the extraction tube. The formation of air bubbles in the specimen well (S) must be avoided.
  4. Read the results at 15-20 minutes. Results after 20 minutes may not be accurate.

Performance Statistics

Who is it for?


International Approval Standard

This device is authorized by Health Canada under the Interim Order #323096


* Authorized use guidelines may vary by province so please contact your local regulators for confirmation on local professional use requirements.