At the individual level, serological tests may be used to support clinical diagnosis by determining recent or previous infection, thereby contributing to quarantine measures, or by determining the immunological status in vaccinated individuals with a view for booster requirements. SARS-CoV-2 serological assays have both clinical and epidemiological uses. Currently, the gold-standard for diagnosing COVID-19 is detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA via real time reverse transcription polymerase chain reaction (rRT-PCR), targets of which may include a combination of nucleocapsid ( N), envelope ( E), RNA-dependent-RNA polymerase (RdRp), and open reading frame ( orf1a and orf1b) genes. 3 The demand for laboratory testing, especially in a timely fashion, is crucial for clinical management and public health efforts to limit transmission. 2 Laboratory markers such as elevated white blood cell count, neutrophil count, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine, troponins, D-dimer and procalcitonin are associated with poorer prognosis for COVID-19 patients. 1 Presence of co-morbidities such as diabetes mellitus, hypertension, and cardiovascular disease confer poorer clinical outcomes and increased mortality. Clinical features include a spectrum ranging from asymptomatic infection, mild acute respiratory illness, fever, and diarrhoea, to that of multi-organ failure requiring intensive care support. In conclusion, all assays exhibited excellent specificity and total antibody assays with spike protein configurations generally outperformed nucleocapsid configurations and IgG assays in terms of diagnostic sensitivity.Ī cluster of unexplained viral pneumonia cases first identified in Wuhan in December 2019 has now progressed to the global pandemic known as the coronavirus disease 2019 (COVID-19). False negatives were observed in a small number of individuals with COVID-19 on immunosuppressive therapy, pauci-symptomatic or who received antiretroviral therapy. Serology results should be interpreted with caution in certain cases. Both also shared the greatest concordance, kappa 0.963 (95% CI 0.885–1.0), p<0.001, and had the lowest false negative rates. OCD and cPass performed the best in terms of sensitivity for >21 days symptoms with 93.3% (95% CI, 73.5–99.2%) and 96.7% (95% CI, 82.8–99.9%), respectively. Testing after at least 14 days from symptom onset is required to achieve AUCs greater than 0.80. Our results showed all assays had specificity ranging from 99.3% to 100.0%. These were concurrently analysed on the different immunoassay platforms and correlated with clinical characteristics. A total of 336 non-duplicated residual serum samples that were obtained from COVID-19 confirmed patients ( n=173) on PCR and negative controls ( n=163) obtained pre-December 2019 before the COVID-19 pandemic were used for the study. In this study, we evaluated and compared six SARS-CoV-2 serology kits including the Abbott SARS-CoV-2 IgG assay, Beckman Access SARS-CoV-2 IgG assay, OCD Vitros OCD Anti-SARS-CoV-2 Total antibody assay, Roche Elecsys Anti SARS-CoV-2 assay, Siemens SARS-CoV-2 Total assay, and cPass surrogate viral neutralising antibody assay.

Abbott diagnostics acquired