SARS-CoV-2 Rapid Antigen Testing Device 2,

Important information & Performance


  • Specimen Type: Nasal swab
  • Simple and Rapid Detection: Results available within 15 minutes.
  • Fast processing of samples. Ability to test in Batch mode 50 tests per hour.
  • Fully mobile device (inbuilt battery),  easy to use, does not require a laboratory or
    highly trained technicians
  • Cost effective method for detecting the coronavirus SARS-CoV-2 at point of care
  • Test cassettes transported and stored at room temperature, 15°c - 35°c
Performance Characteristics
  • Relative Sensitivity: 96.70%
  • Relative Specifity: 99.90%
  • Prevalence 0 - 5 % good exclusion as NPV ≥ 99 %
  • prevalence ≥ 5 %  also good inclusion as PPV ≥ 97 %

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Instructions for Use

Product Manual

View the SARS-CoV-2 Rapid Antigen Testing Device 2 user manual.

Nasopharyngeal Swab Procedure
  1. Encourage the patient to blow his or her nose to clear nasal passage.
    If the patient is unable to perform this task wipe the nares with a cotton tip swab or tissue.
  2. Label the vial with the patient's name, date of birth and time collected.
  3. Perform hand hygiene. Put on a mask, eye protection and gloves.
    • With the person's head in a neutral position,
    • Insert the dry swab through one nostril upwards, along the floor of the nasal passage until you reach the posterior wall of the nasopharynx - generally one half the distance from the corner of the nose to the front of the ear (about 4 to 6 cm or 1.6 - 2.5 inches)
    • Rotate the swab gently then leave in place a few seconds
    • Carefully remove the swab without touching the sides of the nostril
    • Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated with fluid from the first collection. If a deviated septum or blockage create difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.
  4. Open the transport vial and place the swab in the transportation medium.
  1. Open the transport vial and place the swab in the transportation medium.
    Swirl the Reagent Tube to dissolve its contents.
      1. Place the patient swab sample into the Reagent Tube. Roll the swab at least 3 times while pressing the head against the bottom and side of the Reagent Tube.
        Leave the swab in the Reagent Tube for 1 minute.
          1. Roll the swab head against the inside of the Reagent Tube as you remove it. Dispose of the used swab in your biohazard waste.
              1. Fill the provided Small, Clear 120 μL Fixed Volume Pipette with the patient sample from the Reagent Tube.
                To fill the Fixed Volume Pipette with the patient sample:

                a) FIRMLY squeeze the top bulb.
                b) Still squeezing, place the Pipette tip into the patient sample.
                c) With the Pipette tip still in the patient sample, slowly release pressure on bulb to fill the Pipette.
                  1. Firmly squeeze the top bulb to empty the contents of the Small, Clear 120 μL Fixed Volume Pipette into the Test Cassette sample well. Extra liquid left over in the overflow bulb should be left behind.
                      Select between the 2 given modes:
                      WALK AWAY Mode - Walk away and multitask
                      1. In WALK AWAY Mode, the user immediately inserts theTest Cassette into RATD2. Positive and negative test results will be displayed at 15 minutes.
                      READ NOW Mode - Batch multiple samples per hour
                      1. In READ NOW Mode, the user first places the Test Cassette onto the counter or bench top for 15 minutes (outside of RATD2). The user manually times this development step. The Test Cassette MUST remain on the bench for 15 minutes to get an accurate result. Then, the user inserts the Test Cassette into RATD2.
                        In READ NOW Mode, RATD2 will scan and display the test result within 1 minute.
                        Warning: Results must not be interpreted past 30 minutes after inoculation. Using the RATD2 past this time may result in false results.
                      Run the Test
                      1. Input the User ID with the integrated barcode scanner or manually enter the data using the key pad.
                        NOTE: If you scan the wrong barcode, re-highlight the field using the touchscreen on RATD2. The previous one will be overwritten with the right barcode.
                          1. Input the Patient ID and Order # (if applicable) with the integrated barcode scanner or manually enter the data using the key pad.
                              1. Verify that the correct mode (WALKAWAY or READ NOW) has been selected. Press and open the RATD2 drawer.
                                  1. Insert the Test Cassette into the drawer. Then gently close the drawer.
                                      1. RATD2 will start automatically and display the progress. In WALK AWAY Mode, the test results will be displayed in approximately 15 minutes. In READ NOW Mode, the test results will be displayed within 1 minute. See RATD2 Interpretation of Results section.

                                          We provide an overview of what is inside!

                                          Kit Content

                                          Cassette (per box, non reusable)

                                          - 25x Cartridge
                                          - 1x Positive Control
                                          - 1x Negative Control
                                          - 25x Dry-swabs
                                          - 25x Sterile single use pipettes
                                          - 25x Reagent
                                          - 25x Reagent tubes

                                          RATD 2 (per device)

                                          - 1x RATD 2 with integrated barcode scanner (unlimited operations)
                                          - 1x Rechargeable Battery (pre-installed)
                                          - 1x Power Adapter(for battery charge or connection to main power)
                                          - 1x Calibration Cassette Pouch
                                          - 1x Calibration Cassette