After mulling over @Hippie's post on the General Discussion thread (re: RDTs are not part of the current std post-vaccine checks. Tests are usually done via labs for immunity checks/confirmation, when needed, which is for very few non-response situations as vaccines usually spend years in dev before successful release)..
...I went looking for the current market + medical body opinions on this topic.
If you wanna skip the detail, scroll to the end for the summary
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As I had posted earlier in this thread,
18 Sept'20 - Roche company launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines https://www.roche.com/investors/updates/inv-update-2020-09-18b.htm
I now find several more large diagnostic companies with new Ab RDTs targeted towards Covid-19 live trial + post-vaccine checks (+ I found references for 3 other US/EU companies that seem to have similar RDTs in dev)
1 Dec'20 - COVID-19 Antibody Tests Used In Vaccine Clinical Trials Now Available Worldwide
https://www.prnewswire.com/news-releases/covid-19-antibody-tests-used-in-vaccine-clinical-trials-now-available-worldwide-301182827.html
- Meso Scale Diagnostics, V-PLEX® Serology Panels for COVID-19, used for all US Operation Warp Speed vaccine program phase 3 trials
- multiplex technology to simultaneously measure antibodies to many different viral antigens from a single sample. They measure a broad immune response to give a more complete picture of the serological response to vaccination and of SARS-CoV-2 infection and immunity.
+
19 Oct'20 - LabCorp Launches Quantitative Antibody Test to Assess Effectiveness of COVID-19 Vaccines in Clinical Trials
https://www.labcorp.com/coronavirus-disease-covid-19/news/labcorp-launches-quantitative-antibody-test-assess-effectiveness-covid-19-vaccines-clinical-trials
- "Cov2Quant IgG test" "...only for use in clinical trials and research, was developed to specifically detect and quantify antibodies to SARS-CoV-2, the virus that causes COVID-19. The level of antibodies is an important indicator of the strength of a person’s immune response, which can help determine the effectiveness of vaccines and therapies."
(I found a couple opinion articles that referenced above LabCorp RDT + were musing whether such vaccine trial Ab RDTs could be also be used as post-vaccine immunity checkpoint for geos where PCR lab presence is limited/time consuming + where re-doing vaccine delivery or delivering multiple types of vaccines becomes un-feasible due to challenging logistics, time, $ or high risk of re-infections (in case of low efficacy in a pop group or high non-response rate across pops).
+
Siemens Healthineers SARS-CoV-2 IgG (COV2G) Assay is the first FDA EUA-authorized semi-quantitative assay to help clinicians assess the level of an individual‘s immune response over time.
https://www.siemens-healthineers.com/de-ch/laboratory-diagnostics/assays-by-diseases-conditions/infectious-disease-assays/cov2g-assay
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(This Lancet article is very informative, though lengthy and one needs time to digest it properly)
27 Oct'20 - What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30773-8/fulltext
"Clinical trials might not be sufficiently powered to detect vaccine-associated enhanced respiratory disease or serious adverse events related to the vaccine, if they are uncommon. The US FDA recommends that follow-up of study participants should continue for as long as is feasible, ideally for at least 1–2 years, to assess the duration of protection and potential for vaccine-associated enhanced respiratory disease as the immune response to the vaccine wanes. Given that COVID-19 vaccines might be deployed in the early post-marketing period to large populations over a short timeframe, it will be important that robust, ongoing pharmacovigilance is in place post licensure to identify safety signals that large-scale RCTs might not capture"
28 Sept'20 - Is Antibody test the key to measure immune response to the novel coronavirus?
(info article written by Head - Roche Diagnostics India Medical and Scientific Affairs)
https://health.economictimes.indiatimes.com/news/diagnostics/is-antibody-test-the-key-to-measure-immune-response-to-the-novel-coronavirus/78360896
"Antibody tests can be effectively used for:
- Assessing the spread of infection in the community
- Testing effectiveness of vaccines (as intended during clinical trials).
- Prioritization of people to receive vaccines
- Identifying the rate of asymptomatic infection and assessment of mortality attributed to Covid-19 in the community, and identifying the people who are still susceptible to infection.
- Identifying the right donor for convalescent plasma therapy to needy patients.
- As part of the testing algorithm for return to work strategy to minimize the risk of spread of infection."
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I also read a couple dozen opinion pieces, medial journal discussion papers and general media articles around the topic of RDTs for post-vaccine immunity checks, potential post-vaccine pop surveys + re-read some of WHO/gov advice that I had researched previously:
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Summary:
- there is definitely an ongoing discussion about RDTs and vaccine related usage (for/against/on the fence)
- there seems to be a developing market for post-vaccine testing (variety of purposes)
- some diagnostic companies are already targeting this with specifically designed tests being used for trials OR aimed towards post-vaccine checkpints/research/ongoing trials
A few medical industry group/health bodies also seem to be evaluating:
- if + how to use future RDTs to better enhance vaccine success in the 'at-risk' pop groups (based on expected limited supply initially)
- possibly help reduce re-delivery work in case of lower-than-expected success rates
- pharmas and health bodies monitoring vaccine delivery for next few years have the challenge of generating repeated success/qualitative data in large numbers + in a timely manner (which in (low-mid income?) geos, current medical infrastructure will experience challenges to maintain consistently for 1-3yrs duration (est.)
(note: current infection RDTs are not suitable for confirming 'vaccine induced Ab or T-memory cells' since the immunity cells might not be the same as real infection induced cells....I posted about this in my research posts earlier....so we do need to understand from AT1 how they envisage current Ab RDTs being useful in the vaccine world...or if they are other specific tests planned)
