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. 2022 Oct 6;29(1):1–3. doi: 10.1016/j.cmi.2022.10.007

Table 1.

Diagnostic criteria of persistent inflammatory sero-negative COVIDa

A patient is defined as having persistent inflammatory sero-negative COVID if they fulfil the following criteria and no alternative diagnosis:
1. Host criterion B-cell depleting disease or therapy, including the following:
  • Primary immunodeficiency causing hypogammaglobinaemia (X-linked agammaglobulinaemia, common variable immunodeficiency, other primary hypogammaglobinaemia).

  • Secondary immunodeficiency - anti-CD20 treatment in the past year; chronic lymphoblastic leukaemia, non-Hodgkin lymphoma, multiple myeloma accompanied by hypogammaglobinaemia or receiving immunotherapy directed against B cells (bi-specific antibodies or antibody-drug conjugates against CD19, CD20 or BCMA); chimeric antigen receptor T-cell therapy or allogeneic or autologous haematopoietic stem cell transplantation within 1 y.

2. Clinical criterion Prolonged or remitting fever (total >7 d) with elevated CRP levels plus either one of the following: prostration, non-resolving cough and dyspnea (total >14 d), abnormal chest imaging showing pneumonitis (bilateral ground glass opacities).
3. Virological criterion, defined as either of the following
  • Persistent or intermittent positive SARS-CoV-2 RT-PCR result over >21 d.b

  • Positive SARS-CoV-2 RT-PCR result in the last 90 d + sero-negativity for SARS-CoV-2 14 d after the initial infection in monoclonal antibody-naïve patients.c

B-cell maturation antigen (BCMA), CD, cluster of differentiation; COVID, coronavirus disease; CRP, C-reactive protein; Real-time PCR (RT-PCR); SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

a

Being sero-negative before and at the time of the onset of acute infection (regardless and despite vaccination) is a characteristic of this entity. It was not comprehensively included in the criteria for diagnosis because of practical reasons; the diagnosis can be made without a specialized blood test.

b

A positive SARS-CoV-2 result from either a nasopharyngeal swab or lower-respiratory specimen demonstrating the same variant using sequencing supports the diagnosis but is not mandatory.

c

Undetectable levels or low titres according to a local serology platform; patients who were treated with monoclonal antibodies for prevention may have higher titres.