About Albot-Lorven One-Step COVID-19 Antigen test

One Step COVID-19 Antigen Rapid Detection Kit aims to expedite the screening process by providing rapid differential diagnosis of COVID-19 virus infection.

The kit is based on immunochromatographic assay for the detection of novel Coronavirus antigen (viral nucleoprotein) from nasal swab, nasopharyngeal swab, endotracheal aspirate or bronchoalveolar lavage obtained from a patient with signs and symptoms of respiratory infection.

How does it work?

Albot-Lorven One-Step COVID-19 Antigen test is an antigen-capture immunochromatographic assay, detecting the presence of COVID-19 viral nucleoprotein antigen in nasal and nasopharyngeal swab samples.

The assay involves extraction of viral antigen from the sample or specimen, followed by solid-phase immunoassay technology for the detection of extracted antigen.

With the help of colloidal gold COVID-19 antibodies are first conjugated. The conjugated antibodies are then deposited on the conjugate pad and immobilized on the test zone of the nitrocellulose membrane. The gold-antibody conjugate is rehydrated when a specimen is added.

If there are any COVID-19 antigen in the specimen it will interact with the gold conjugated antibodies. The antigen-antibody-gold complex will migrate towards the test window of the test zone where they will be captured by immobilized antibodies, forming a visible pink line (test band) indicating a positive result. There will be no pink line in the test zone (T), if COVID-19 antigen is absent in the specimen.

To serve as internal process control, a control region was designed to indicate the test performance. By utilizing the different antigen/antibody reactions, the control line should always be seen after the test is completed. The absence of a pink control line in the control region is an indication of an invalid result.

What does the package contain?

  • A pouch with test cassette and desiccant
  • A Reagent solution bottle (includes 10ml reagent solution) and the reagent tube
  • Sterilized nasal swabs
  • Testing instructions
  • *The tester should wear protective gears such as latex gloves which are not included in the kit but are crucial for safety purposes.

    How to use?

    For proper detection of COVID-19 antigen, correct specimen collection and preparation methods must be followed. The correct method of collecting samples for the test is:
    Nasal Swab Sample –

    • Step 1- To collect a nasal sample, insert the sterile Swab into a nostril.
    • Step 2- Push the Swab by gently rotating it until it meets resistance at the level of the turbinate (less than one inch into the nostril).
    • Step 3- Rotate the Swab a few times against the nasal wall.
    Nasopharyngeal Swab Sample -
    • Step 1- To collect a nasopharyngeal Swab sample, carefully insert the sterile Swab into a nostril.
    • Step 2- Gently push the Swab into the posterior nasopharynxKeep while keeping the Swab near the septum floor of the nose.
    • Step 3- Rotate the Swab several times.
    Points to Note -
    • Insert the swab in the nostril that presents the most secretions under visual inspection because it is important to obtain as much sample as possible.
    • Freshly collected specimens must be processed at the earliest, within one hour of the specimen collection.
    • Reagent, specimens, and devices must be kept at room temperature (15-30℃) before the test. And, for optimal test performance, use the swabs supplied in the kit.

    Testing Procedure –

    1. Add 300ul reagent solution (about 9 drops) into the reagent tube.
    2. Add Nasal/Nasopharyngeal Swab to the tube containing the reagent solution.
    3. Rotate and twist the Swab rigorously at least 10 times against the side of the tube.
    4. Squeeze both sides of the tube to procure as much liquid as possible. Dispose the Swab properly.
    5. Apply the cap to the tube with the specimen, hold the tube vertically, and add 5 drops (about 120 μl) of the specimen without air bubbles onto the testing kit.
    6. Read the results after 20 minutes.

    *Note: For condensed samples, if the sample does not migrate to the membrane within 20 seconds, apply one to two more drops of reagent solution to help the sample migrate to the membrane.

    How to interpret?

    • Negative -
      A clear pink colored band will appear at the control region (C) only, to indicate a negative result for COVID-19 Infection.
    • Positive -
      A clear pink control band (C) and a detectable test band (T) will appear to indicate a positive result for COVID-19 infection.
    • Invalid -
      There will be no visible band at the control region. In such a case, repeat with a new test kit and please contact the distributor with the lot number for the invalid test.

    *Caution: Please ignore the test results after 30 minutes.

    Precautions –

    • An unopened and sealed kit can be stored at room temperature (2-26°C) up to the expiration date
    • The kit is solely meant for in-vitro diagnostic use
    • Do not reuse
    • Do not use if the pouch seal is broken or if the packaging is compromised in any way
    • Do not use if the expiration date given on the pouch has passed
    • Do not mix and interchange different specimens
    • Wear protective clothing such as laboratory coats, disposable gloves, and eye protection while performing the assay
    • Wash hands thoroughly after finishing the tests
    • Do not eat, drink, or smoke anywhere near where the specimens or kits are being handled
    • Clean up spills thoroughly with appropriate disinfectants
    • Handle all specimens as if they contain infectious agents and do observe established precautions against microbiological hazards
    • Dispose of all the specimens as well as the used devices in a proper biohazard container (follow local, national, or regional regulations on handling and disposal of hazardous materials)
    • Keep out of children’s reach
    • Do not freeze the test device and keep it away from direct sunlight, moisture, and heat
    Note: Negative results should be further confirmed with RT-PCR if COVID-19 symptoms are prevalent.

    Why Use the Albot-Lorven COVID-19 Antigen Rapid Detection Test Kit?

    1. Tests can be conducted on self without travelling to diagnostic centers.
    2. It enables decentralizing of COVID-19 testing and allows testing in areas with no or limited laboratory testing access.
    3. It is extremely easy to use and gives quick yet reliable COVID-19 results.
    4. No specialized training is required for using the kit or for doing the test.
    5. Most of the necessary instruments for the testing are already included in the kit.

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