Diagnostic performance of commercially available COVID-19 serology tests in Brazil.
Int J Infect Dis
; 101: 382-390, 2020 Dec.
Article
in English
| MEDLINE | ID: covidwho-843546
ABSTRACT
Timely and accurate laboratory testing is essential for managing the global COVID-19 pandemic. Reverse transcription polymerase chain reaction remains the gold-standard for SARS-CoV-2 diagnosis, but several practical issues limit the test's use. Immunoassays have been indicated as an alternative for individual and mass testing. OBJECTIVES:
To access the performance of 12 serological tests for COVID-19 diagnosis.METHODS:
We conducted a blind evaluation of six lateral-flow immunoassays (LFIAs) and six enzyme-linked immunosorbent assays (ELISAs) commercially available in Brazil for detecting anti-SARS-CoV-2 antibodies.RESULTS:
Considering patients with seven or more days of symptoms, the sensitivity ranged from 59.5% to 83.1% for LFIAs and from 50.7% to 92.6% for ELISAs. For both methods, the sensitivity increased with clinical severity and days of symptoms. The agreement among LFIAs performed with digital blood and serum was moderate. Specificity was, in general, higher for LFIAs than for ELISAs. Infectious diseases prevalent in the tropics, such as HIV, leishmaniasis, arboviruses, and malaria, represent conditions with the potential to cause false-positive results with these tests, which significantly compromises their specificity.CONCLUSION:
The performance of immunoassays was only moderate, affected by the duration and clinical severity of the disease. Absence of discriminatory power between IgM/IgA and IgG has also been demonstrated, which prevents the use of acute-phase antibodies for decisions on social isolation.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Enzyme-Linked Immunosorbent Assay
/
Immunoassay
/
COVID-19
Type of study:
Diagnostic study
/
Experimental Studies
/
Observational study
/
Prognostic study
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
/
Young adult
Country/Region as subject:
South America
/
Brazil
Language:
English
Journal:
Int J Infect Dis
Journal subject:
Communicable Diseases
Year:
2020
Document Type:
Article
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