Covid 19 Rapid Antigen Testing

An additional layer of protection for your facility by adding instant identification of infections. 

Simplify testing with results in just 10 minutes – Accurate diagnostic test solutions for screening for COVID-19 at the point of care, without the need for laboratory-based testing. Performing antigen and antibody tests in parallel enables detection of current or prior infection from the SARS-CoV-2 virus, optimising population screening and patient triage programs.

Since the first outbreak reported in December 2019, SARS-CoV-2 has spread rapidly worldwide, and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). Due to its highly contagious nature and global health crises, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO). SARS-CoV-2 continues to have devastating impacts on healthcare systems and the world economy.

To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical. Particularly, the identification of subclinical or asymptomatic cases is important to reduce or stop the infection because these individuals may transmit the virus. As a point of care test with a 10 minute testing time, Atomo COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.

Intended use – The Atomo Covid19 Antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly collected from individuals at the point of care (POC).

Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen, generally detected during the acute phase of the infection.

Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.

The Atomo COVID-19 Antigen Test is intended for use by medical and healthcare professionals who are proficient in performing tests in point of care settings or trained clinical laboratory personnel.

How it works
  1. Remove nasal swab from pouch
  2. Insert the swab into one of the patient’s nostrils up to 2-3cm from the edge of the nostril
  3. Slowly roll the swab 5 times over the surface of the nostril. Using the same swab, repeat this collection process in the other nostril.
  4. Slowly remove the swab from the nostril while rotating it.

5. Peel off seal from the top of the extraction vial containing the extraction buffer.

6. Place the swab into the extraction vial. Rotate the swab vigorously at least 5 times

7. Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab.

8. Close the vial the vial with the provided cap and push firmly into the vial.

9. Mix thoroughly by flicking the bottom of the tube.

10. Invert the extraction vial and squeeze the vial gently allowing 3 drops to fall into the sample

11. Read and interpret the test result at 10 min.

Interpretation of results

Positive: Two distinct coloured lines appear

Negative: One red coloured line next to “C’ indicates a negative result

Invalid: If the red-coloured line in the control region “C” is not visible, the result is invalid. Re-run the test one time using a new device with the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.

The Atomo COVID-19 Antigen Test has been developed for healthcare professionals and is available for use by registered medical practitioners; healthcare professionals in residential and aged care facilities; pathology laboratories; Commonwealth, State, or Territory departments of health, and agencies acting on their behalf.

For professional in vitro diagnostic use only. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. Immediately use after opening the test device in the pouch. In order to obtain accurate results, the user must follow the manufacturer’s instructions. 

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