Clinical sensitivity and interpretation of PCR and serological COVID-19 diagnostics for patients presenting to the hospital.

Autor: Miller TE; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Garcia Beltran WF; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Bard AZ; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Gogakos T; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Anahtar MN; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Astudillo MG; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Yang D; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Thierauf J; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Fisch AS; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Mahowald GK; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Fitzpatrick MJ; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Nardi V; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Feldman J; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA., Hauser BM; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA., Caradonna TM; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA., Marble HD; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Ritterhouse LL; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Turbett SE; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.; Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Batten J; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Georgantas NZ; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Alter G; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA., Schmidt AG; Ragon Institute of MGH, MIT, and Harvard, Cambridge, MA, USA., Harris JB; Division of Infectious Diseases, Department of Pediatrics, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Gelfand JA; Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Poznansky MC; Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Bernstein BE; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Louis DN; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Dighe A; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Charles RC; Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Ryan ET; Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Branda JA; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Pierce VM; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.; Division of Infectious Diseases, Department of Pediatrics, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Murali MR; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.; Division of Allergy and Immunology, Department of Medicine, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Iafrate AJ; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Rosenberg ES; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.; Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA., Lennerz JK; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.
Jazyk: angličtina
Zdroj: FASEB journal : official publication of the Federation of American Societies for Experimental Biology [FASEB J] 2020 Oct; Vol. 34 (10), pp. 13877-13884. Date of Electronic Publication: 2020 Aug 28.
DOI: 10.1096/fj.202001700RR
Abstrakt: The diagnosis of COVID-19 requires integration of clinical and laboratory data. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic assays play a central role in diagnosis and have fixed technical performance metrics. Interpretation becomes challenging because the clinical sensitivity changes as the virus clears and the immune response emerges. Our goal was to examine the clinical sensitivity of two most common SARS-CoV-2 diagnostic test modalities, polymerase chain reaction (PCR) and serology, over the disease course to provide insight into their clinical interpretation in patients presenting to the hospital. We conducted a single-center, retrospective study. To derive clinical sensitivity of PCR, we identified 209 PCR-positive SARS-CoV-2 patients with multiple PCR test results (624 total PCR tests) and calculated daily sensitivity from date of symptom onset or first positive test. Clinical sensitivity of PCR decreased with days post symptom onset with >90% clinical sensitivity during the first 5 days after symptom onset, 70%-71% from Days 9 to 11, and 30% at Day 21. To calculate daily clinical sensitivity by serology, we utilized 157 PCR-positive patients with a total of 197 specimens tested by enzyme-linked immunosorbent assay for IgM, IgG, and IgA anti-SARS-CoV-2 antibodies. In contrast to PCR, serological sensitivity increased with days post symptom onset with >50% of patients seropositive by at least one antibody isotype after Day 7, >80% after Day 12, and 100% by Day 21. Taken together, PCR and serology are complimentary modalities that require time-dependent interpretation. Superimposition of sensitivities over time indicate that serology can function as a reliable diagnostic aid indicating recent or prior infection.
(© 2020 Massachusetts General Hospital, Center for Integrated Diagnostics. The FASEB Journal published by Wiley Periodicals LLC on behalf of Federation of American Societies for Experimental Biology.)
Databáze: MEDLINE
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