Ref TGA
https://www.tga.gov.au/covid-19-point-care-testsRef Doherty Institute
https://www.health.gov.au/sites/default/files/documents/2020/09/post-market-validation-of-a-further-5-serological-assays-for-covid-19-updated-report-post-market-validation-of-a-further-5-serological-assays-for-covid-19.pdfNot sure if this has been posted before, my apology if it has.
Re-looking at the TGA stated POC requirements, which are worth reviewing, I found
12 Jan 2022
Point-of-care tests can be used outside the laboratory setting by a health practitioner, or trained staff under their supervision, to test a person for COVID-19. This ensures a suitable health practitioner, or trained person under their supervision is available to ensure an adequate sample is collected, correct interpretation of results and provide immediate clinical advice and treatment if required.
But now "At Home" tests are the basis of our knowledge and response to the pandemic???What is meant by supervision of testing?
Supervision is a key responsibility for controlling the risks to patient safety and welfare that may arise while providing a testing service. Supervision of testing goes to the professional conduct of a practitioner. Failure to appropriately supervise testing may amount to professional misconduct. The practitioner remains liable at all times for the conduct of the testing.
Once appropriately trained in the correct use of the device, persons under the supervision of a health practitioner, including a medical practitioner and pharmacist, may perform the test. The relevant health practitioner responsible for supervision of testing is required to ensure all persons performing the test (including sample collection, performing tests and interpreting test results) under their supervision are appropriately trained in all matters related to good testing practice, including:
- infection control practices, including assessment of any site specific work, health and safety risks;
- the collection of samples, or where applicable the supervision of self-collection in order to verify patient identification, sample collection, test performance and test results;
- the correct use of the device and interpretation of test results;
- where relevant, protocols for recording results and any reporting requirements so they can advise individuals when they are required to report a positive test result to their state or territory health department; and
- protocols for reporting any problems or adverse events associated with performance of the test to the Therapeutic Goods Administration.
So using a more accurate device that does the reading etc is second to "At home" devices with no control?Doherty Institute tested 5 POC approved devices back in Sept last year (ref above), below is the discussion
4. Discussion
Here, we present results of our post-market validation of the PCL COVID19 IgG/IgM
Rapid, the Cellex qSARS-CoV-2 IgG/IgM Rapid Test Kit, the COVID-19 IgG/IgM Rapid
Test Cassette (Zhejiang Gene Orient), the LYHER Novel Coronavirus (2019-n)
IgM/IgG Antibody Combo Test Kit, and the Diagnostic Kit for IgM/IgG Antibody to
Coronavirus (SARS-CoV-2) (Zhuhai Livzon). Not all tests met their stated performance
characteristics with respect to sensitivity, but all were within the stated IFU range for
specificity.
The sensitivity for both components of the assay, IgM and IgG, was found to be low
for the PCL COVID19 IgG/IgM Rapid and the Diagnostic Kit for IgM/IgG Antibody to
Coronavirus (SARS-CoV-2) (Zhuhai Livzon), even for specimens collected more than
14 days following symptom onset. Performance characteristics were not stated in the
manufacturer’s IFU for the PCL COVID19 IgG/IgM Rapid, and for the Diagnostic Kit
for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Zhuhai Livzon) the sensitivity fell
significantly below that reported by the manufacturer.
Sensitivity for IgM component was significantly lower than that reported by the
manufacturer for both the Cellex qSARS-CoV-2 IgG/IgM Rapid Test Kit and the
COVID-19 IgG/IgM Rapid Test Cassette (Zhejiang Gene Orient). IgG components for
both assays were either in agreement with, or within the confidence intervals reported
by the manufacturer, with the COVID-19 IgG/IgM Rapid Test Cassette (Zhejiang Gene
Orient) reporting the higher sensitivity, 97.4% (95%CI: 86.2-99.9%) versus 86.8%
(95% CI: 71.9-95.6%), when analysing convalescent samples.
Sensitivity results for the IgM or IgG component alone were not available from the
manufacturer for the LYHER Novel Coronavirus (2019-n) IgM/IgG Antibody Combo
Test Kit. Combined sensitivity results for either IgM or IgG fell just short, but with
overlapping confidence intervals, of the manufacturers reported values for
convalescent samples, at 86.8% (95%CI: 71.9-95.6%) compared to 96.98% (95%CI:
94.51-98.54%).
In summary, our data describe the performance characteristics of five further PoCT
devices. Specificity findings are more often consistent with those reported by the
manufacturer in the accompanying IFU, compared to sensitivity findings which are
quite variable depending on the assay. Careful test selection and consideration of
clinical utility remain critical in the appropriate utilisation of these assays.
In the reference I read the tables to say that only 1 unit is really worth having, the other 4 are substandard.
(20min delay)