Tests and more tests

Found 2 sites with interesting information. My apologies if been listed before.
TGA approved tests use the filter to see only POC tests
A comparison of POC tests Note the extract below is from this site. Version published: 24 March 2021
It would seem there are not to many tests that have undergone a regulated test procedure. Most seem to have been done in house on some dubious data/methods. So the TGA list being as long as it is may have only a couple of direct competition to us.
Our BOD has gone the other way and been confident enough to let other organisations qualify our performance. Hopeful that will produce the point of difference for our Eugeni test. Bring on the results.

"Main results

Antigen tests

In people with confirmed COVID‐19, antigen tests correctly identified COVID‐19 infection in an average of 72% of people with symptoms, compared to 58% of people without symptoms. Tests were most accurate when used in the first week after symptoms first developed (an average of 78% of confirmed cases had positive antigen tests). This is likely to be because people have the most virus in their system in the first days after they are infected.

In people who did not have COVID‐19, antigen tests correctly ruled out infection in 99.5% of people with symptoms and 98.9% of people without symptoms.

Different brands of tests varied in accuracy. Pooled results for one test (SD Biosensor STANDARD Q) met World Health Organization (WHO) standards as ‘acceptable’ for confirming and ruling out COVID‐19 in people with signs and symptoms of COVID‐19. Two more tests met the WHO acceptable standards (Abbott Panbio and BIONOTE NowCheck) in at least one study.

Using summary results for SD Biosensor STANDARD Q, if 1000 people with symptoms had the antigen test, and 50 (5%) of them really had COVID‐19:

‐ 53 people would test positive for COVID‐19. Of these, 9 people (17%) would not have COVID‐19 (false positive result).

‐ 947 people would test negative for COVID‐19. Of these, 6 people (0.6%) would actually have COVID‐19 (false negative result).

In people with no symptoms of COVID‐19 the number of confirmed cases is expected to be much lower than in people with symptoms. Using summary results for SD Biosensor STANDARD Q in a bigger population of 10,000 people with no symptoms, where 50 (0.5%) of them really had COVID‐19:

‐ 125 people would test positive for COVID‐19. Of these, 90 people (72%) would not have COVID‐19 (false positive result).

‐ 9,875 people would test negative for COVID‐19. Of these, 15 people (0.2%) would actually have COVID‐19 (false negative result).

Molecular tests

Although overall results for diagnosing and ruling out COVID‐19 were good (95.1% of infections correctly diagnosed and 99% correctly ruled out), 69% of the studies used the tests in laboratories instead of at the point‐of‐care and few studies followed test manufacturer instructions. Most of the data relate to the ID NOW and Xpert Xpress tests. We noted a large difference in COVID‐19 detection between the two tests, but we cannot be certain about whether results will remain the same in a real world setting. We could not investigate differences in people with or without symptoms, nor time from when symptoms first showed because the studies did not provide enough information about their participants.

How reliable were the results of the studies?

In general, studies that assessed antigen tests used more rigorous methods than those that assessed molecular tests, particularly when selecting participants and performing the tests. Sometimes studies did not perform the test on the people for whom it was intended and did not follow the manufacturers’ instructions for using the test. Sometimes the tests were not carried out at the point‐of‐care. Nearly all the studies (97%) relied on a single negative RT‐PCR result as evidence of no COVID‐19 infection. Results from different test brands varied, and few studies directly compared one test brand with another. Finally, not all studies gave enough information about their participants for us to judge how long they had had symptoms, or even whether or not they had symptoms.

What does this mean?

Some antigen tests are accurate enough to replace RT‐PCR when used in people with symptoms. This would be most useful when quick decisions are needed about patient care, or if RT‐PCR is not available. Antigen tests may be most useful to identify outbreaks, or to select people with symptoms for further testing with PCR, allowing self‐isolation or contact tracing and reducing the burden on laboratory services. People who receive a negative antigen test result may still be infected.

Several point‐of‐care molecular tests show very high accuracy and potential for use, but more evidence of their performance when evaluated in real life settings is required.

We need more evidence on rapid testing in people without symptoms, on the accuracy of repeated testing, testing in non‐healthcare settings such as schools (including self‐testing), and direct comparisons of test brands, with testers following manufacturers’ instructions.

How up‐to‐date is this review?

This review updates our previous review and includes evidence published up to 30 September 2020"