Diagnosis

There is no biomarker available to confirm if someone has had a COVID-19 vaccine reaction, and existing tests are also proving difficult for different aspects of vaccine injuries.

Whilst there are well-established tests available for myocarditis and pericarditis, for example, there are many patients who nevertheless present with clinical symptoms of these conditions yet the available diagnostic tests still fail to confirm the doctor’s suspicions.

In many cases, however, physicians are being confronted with curious or rare constellations of symptoms, for which standard and obvious tests fail to provide enough useful insights.

React19 in the USA has prepared an extensive Diagnostic Workup Guide, largely to assist medical professionals and their patients with deeper investigations where warranted. These tests are not endorsed by us, and we note that a number of the tests listed in this guide are quite specialised and may not be available in Australia (e.g. Small Fiber Neuropathy biopsy and various pathology tests). We also note that some of the tests described in this guide may be particularly dangerous for some patients, so should only be pursued by the appropriate specialist after careful consideration of their potential diagnostic benefit weighed up against the risk to the patient.

Note that an update to this Diagnostic Workup Guide is being planned. If, as an Australian physician, you have any experiences from your practice that could be usefully added then please contact us with details.

Overseas tests

There are several specific tests available overseas that may provide helpful insight in some patient cases. However, we are not yet aware of any instances of patients in Australia who have successfully utilised any of these.

Below is a list of some of these tests, and we would appreciate your feedback if you have been able to arrange these tests for any of your patients.

Small Fibre Neuropathy biopsy

The Neurology Laboratory at the University of Sydney has been planning to develop diagnostic capabilities for detecting Small Fibre Neuropathy (SFN). These plans were put on hold due to the pandemic, and we are not aware of when, or if, this capability may be implemented.

We have heard that it may be possible to send samples overseas for analysis, however do not have details beyond this.

In the US, the National Institute of Neurological Disorders and Stroke (NINDS) undertook a detailed analysis of a cohort of vaccine-injured patients, utilising their state-of-the-art diagnostic capabilities, and demonstrated clear evidence of immune-mediated harms including SFN. Their findings are available in preprint: doi:10.1101/2022.05.16.22274439. We make a caveat regarding this preprint, however, noting that their claims that all patients recovered after the indicated treatment appears to have been premature. We have spoken with a number of the patients, and it is quite clear that most, if not all, of the cohort continue to suffer significant health issues.

Cytokine & S1 spike panels

IncellDX is a US diagnostics company that has developed a cytokine marker panel and a panel that can detect the enduring presence of S1 spike protein in monocytes. They have also developed a treatment approach to clear these affected monocytes from the body. We are aware of efforts to make these tests and treatments available in Australia, however it does not yet look like they have done so. Their website to order relevant tests and access treatment advice is www.covidlonghaulers.com.

A clinical trial is underway for the treatment approach, and several relevant papers have been published:

  • “Immune-Based Prediction of COVID-19 Severity and Chronicity Decoded Using Machine Learning”, Frontiers in Immunology, 12:700782, 28 June 2021. doi:10.3389/fimmu.2021.700782
  • “Persistence of SARS CoV-2 S1 Protein in CD16+ Monocytes in Post-Acute Sequelae of COVID-19 (PASC) up to 15 Months Post-Infection”, Frontiers in Immunology, 12:746021, 10 January 2022. doi:10.3389/fimmu.2021.746021
  • “Case series: Maraviroc and pravastatin as a therapeutic option to treat long COVID/Post-acute sequelae of COVID (PASC)”, Frontiers in Medicine, 10:1122529, 8 February 2023. doi:10.3389/fmed.2023.1122529

A video interview with the founder of IncellDX goes into detail of their findings and treatment approach: youtu.be/cH-8hMXcE2U

Auto-antibody assays

German biotech company CellTrend has developed immuno-assays for the detection of a range of auto-antibodies. This capability has been utilised as both a diagnostic for complex diseases such as Long Covid and Long Vax, as well as help guide treatments.

It appears as thought the tests can be ordered internationally. We have heard that some Australians have done this, however we are unaware if the results were able to help guide any meaningful treatment in Australia.

The vaccine-injured support group in Germany, Post-Vac Syndrom Deutschland, has collaborated with several Germany medical universities to undertake a study of auto-antibodies (and other immune markers) in vaccine-injured patients, and they have published their findings that differentiate patients with Long Vax from those without: doi:10.3390/vaccines11111642.

Micro-clot immunostaining

Since early in the pandemic unusual clots, dubbed “micro-clots”, have been observed in patients with Long Covid, utilising immunostaining techniques and observation under microscope. The same diagnostic methods are showing similar issues present in patients with Long Vax conditions.

While this technique is widely available, and indeed we have been informed that numerous research labs in Australian have the ability to perform this, we are not aware of a single Australian institution that is looking at micro-clots in Long Covid or Long Vax patients.

At the forefront of this research is Resia Pretorius in South Africa. In the USA, the Petrino Lab at Mount Sinai, as well as other clinical groups, are actively using this approach to assist with diagnosing Long Covid (and Long Vax) patients to help guide treatments. Research papers that explore micro-clots, and potential treatments, include:

  • “SARS-CoV-2 spike protein S1 induces fibrin(ogen) resistant to fibrinolysis: implications for microclot formation in COVID-19”, Bioscience Reports, 41(8), 30 July 2021. doi:10.1042/BSR20210611
  • “The Occurrence of Hyperactivated Platelets and Fibrinaloid Microclots in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)”, Pharmaceuticals, 5(8):931, 27 July 2022. doi:10.3390/ph15080931
  • “Prevalence of symptoms, comorbidities, fibrin amyloid microclots and platelet pathology in individuals with Long COVID/Post-Acute Sequelae of COVID-19 (PASC)”, Cardiovascular Diabetology, 21:148, 6 August 2022. doi:10.1186/s12933-022-01579-5
  • “Proteomics of fibrin amyloid microclots in long COVID/post-acute sequelae of COVID-19 (PASC) shows many entrapped pro-inflammatory molecules that may also contribute to a failed fibrinolytic system”, Cardiovascular Diabetology, 21:190, 21 September 2022. doi:10.1186/s12933-022-01623-4
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