MP Bio Rapid Antigen Test Kit_Global Insights

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RAPID SARS-COV-2 ANTIGEN TEST

GLOBAL INSIGHTS

HOW ANTIGEN TESTS WORK A SARS-CoV-2 is a chromatographic immunoassay test which detects viral antigens present when a person is infected.

Rapid antigen test cards use a strip pre-coated with a gold conjugate which is rehydrated when a sample is applied.

The control line (C) is coated with a monoclonal antibody which will react with a human sample. As the sample moves upward, this antibody will bind and trap normal antigens and show a line, indicating that the test is valid.

The test line (T) is coated with a human antibody specific to SARS-CoV-2 and will bind to any covid antigens present in the sample, turning the small coating into a different colour, thus indicating a positive test.

ADVANTAGES OF RAPID TESTING RAT Testing provides huge benefits both commercially and from a safety point of view.

Conducting screening tests for workers onsite provides a rapid solution to what is otherwise very costly and very time consuming. » Result in 15 minutes » Detection of virus at acute infectious phase » 7-times cheaper than PCR testing » Ease of use » Ability to site test » Does not require special storage » High sensitivity & specificity

TYPICAL RAPID ANTIGEN TESTING STEPS

Swab Nasopharyngeal Oropharyngeal Nasal

Sample Extraction

Application to Test Card

Swab is held in extraction medium to retain viral proteins (If present)

3 drops of viral media are added to the test card.

Wait 10-15 Minutes

Interpretation of Results

LEGISLATION

Conditions for Supply and Use TGA (Therapeutic Goods Australia) requires sale to be made only under certain circumstances.

Despite this, regulations are simple.

Conditions to note are: SARS-CoV-2 Rapid Antigen Testing kits can only legally be sold to: » Commercial groups who employ a registered health practitioner* to oversee testing » Residential Care and Aged/Disability Care groups who engage a registered health practitioner to oversee testing » Registered Medical Practitioners Training must be given to everyone who will perform the test on how to use the device and how to interpret results. This needs to be taken prior to the commencement of any testing.

Any group using antigen test kits (as mentioned above) MUST unless the TGA says otherwise, conduct tests under the supervision of a registered health practitioner.

Tests cannot be legally sold unless they are registered by the TGA on the ARTG (Australian Register of Therapeutic Goods).

What is a ‘registered health practitioner’?

This term is used under the meaning of Section 3 of the Therapeutic Goods Act 1989 and notably does not say ‘registered medical practitioner’.

This means someone licensed under state or territory law to practice. This includes podiatrists, pharmacists, nurses, dentists and more, but does not include assistants to such personnel.

These people will hold a lot of responsibility including: » Infection Control » Sample Collection » Correct Use of the devices » Recording and reporting protocol » Referral and retesting protocol » Recording and reporting of false positives or invalid test results » Liability for testing conduct This may determine the scope of your testing rollout; the TGA notes that this can be as simple as having a health practitioner engaged onsite or via live video to supervise the testing process.

Disclaimer: Westlab Pty Ltd is providing information cited from the TGA website: Q&As - Conditions of supply for rapid antigen tests | Therapeutic Goods Administration (TGA). The information provided is a guide and not legal advice

FREQUENTLY ASKED QUESTIONS Are rapid antigen tests accurate?

Accuracy of RAT kits depends entirely on the manufacturer. RAT kits are not as accurate as PCR laboratory tests, as PCR is a very advanced testing method. Depending on the manufacturer, antigen test kits, however, can be highly accurate. The MP Biomedical antigen test kit is over 98% accurate. The key benefit of an antigen test kit is that false negatives do not occur, only invalid or false positives. Backed up with PCR confirmation, RAT processes enhance infection control.

How long does RAT screening take?

RAT testing is a very rapid process, taking only 15 minutes to get a result, and about 20 minutes in total. In fact, waiting any longer than around 20 mins for a result can impact the integrity of the test.

What if staff do not wish to take the test?

The TGA have made provision for efficiency and preference when testing. So long as onsite staff are trained and supervised by the registered health practitioner, swabbing can be self-conducted under supervision, and there are several swab types available. Organisations rolling out this process may consider implementing policy stating that conditions of site entry rely on receiving a negative test.

Is it effective against the Delta strain?

Not all tests are either effective or tested against the Delta strain. This is one of the most infectious strains of SARSCoV-2 and is a concern to disease control centres globally. Ensure you find a test that is tested against the Delta strain to ensure screening is effective.

UK ROLL-OUT The UK made moves to “rely less on economic and social restrictions and more on … scientific progress” to fight the virus proactively.

Community Testing Community Testing (pre self-test) – DHSC did a roll-out to high priority areas with professional tests. Roll-out was based on professional use staff – they trained the army to take the tests.

Self-Testing MHRA (equivalent to TGA) made a new derogation process for a brand of self-test to be exempted for self-test use. This was focused on asymptomatic people.

Vulnerable For aged and disability care, visitors and residents were tested heavily early on – this was relatively easy as nurses were on site to professionally administer.

Trialling the program DHSC arranged a mass-testing weekend in Liverpool – to trial mass testing and effect it would have on infection rates.

HEADING Subheading Content Manufactured in Singapore by MP Biomedicals Conditions of sale under TGA regulation apply

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