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Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays
- Source :
- Biochemia Medica, Volume 31, Issue 1
- Publication Year :
- 2021
- Publisher :
- Croatian Society of Medical Biochemistry and Laboratory Medicine, 2021.
-
Abstract
- Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests have been suggested as an additional diagnostic tool in highly suspected cases with a negative molecular test and determination of seroprevalence in population. We compared the diagnostic performance of eight commercial serological assays for IgA, IgM, and IgG antibodies to the SARS-CoV-2 virus. Materials and methods: The comparison study was performed on a total of 76 serum samples: 30 SARS-CoV-2 polymerase chain reaction (PCR)- negative and 46 SARS-CoV-2 PCR-positive patients with asymptomatic to severe disease and symptoms duration from 3-30 days. The study included: three rapid lateral flow immunochromatographic assays (LFIC), two enzyme-linked immunosorbent assays (ELISA), and three chemiluminescence immunoassays (CLIA). Results: Agreement between IgM assays were minimal to moderate (kappa 0.26 to 0.63) and for IgG moderate to excellent (kappa 0.72 to 0.92). Sensitivities improved with > 10 days of symptoms and were: 30% to 89% for IgM; 89% to 100% for IgG; 96% for IgA; 100% for IgA/IgM combination; 96% for total antibodies. Overall specificities were: 90% to 100% for IgM; 85% to 100% for IgG; 90% for IgA; 70% for IgA/IgM combination; 100% for total antibodies. Diagnostic accuracy for IgG ELISA and CIA assays were excellent (AUC ≥ 0.90), without significant difference. IgA showed significantly better diagnostic accuracy than IgM (P < 0.001). Conclusion: There is high variability between IgM assays independently of the assay format, while IgG assays showed moderate to perfect agreement. The appropriate time for testing is crucial for the proper immunity investigation.
- Subjects :
- 030213 general clinical medicine
medicine.medical_specialty
Clinical Biochemistry
Population
specificity
Gastroenterology
Asymptomatic
Sensitivity and Specificity
Virus
law.invention
Serology
03 medical and health sciences
0302 clinical medicine
COVID-19 Testing
law
Internal medicine
Medicine
Seroprevalence
Humans
Serologic Tests
education
Polymerase chain reaction
030304 developmental biology
0303 health sciences
education.field_of_study
biology
business.industry
SARS-CoV-2
sensitivity
serological test
Biochemistry (medical)
COVID-19
Original Articles
biology.protein
medicine.symptom
Antibody
business
Kappa
Subjects
Details
- Language :
- English
- ISSN :
- 18467482 and 13300962
- Volume :
- 31
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Biochemia Medica
- Accession number :
- edsair.doi.dedup.....ea16ef5466704b0883257c1292a7f0ff