ABSTRACT
OBJECTIVE: To assess the diagnostic performance of lateral flow immunochromatographic assays (LFAs) of 4 different manufacturers to identify SARS-CoV-2 antibodies (IgM, IgG, or total), comparing them with the nucleic acid amplification test (NAAT) or the clinical defined test (definite or probable SARS-CoV-2 infection, respectively). METHODS: One hundred nineteen serum samples were randomly selected by convenience and distributed in the following groups: (1) group with SARS-CoV-2 infection (n = 82; RT-qPCR positive [definite, n = 70] and probable [n = 12]); (2) other diseases (n = 27; other viruses identified [n = 8] and SARS of other etiologies [n = 19]); and (3) healthy control group (n = 10). LFAs of 4 manufacturers were compared: MedTest Coronavirus (COVID-19) IgG/IgM (MedLevensohn, Brazil); COVID-19 IgG/IgM ECO Test (Ecodiagnóstica, Brazil); Camtech COVID-19 IgM/IgG Rapid Test Kit (Camtech Diagnostics Pte Ltd, Singapore); and 1-Step COVID-19 Test for total antibodies (Guangzhou Wondfo Biotech Co., China). RESULTS: The 4 tests studied showed high diagnostic performance characteristics for the diagnoses of definite or probable SARS-CoV-2 infection. The best measures were for the Wondfo test: sensitivity (86.59%; 95% CI: 77.26-93.11%), specificity (100%; 90.51-100%), DOR (257; 60-1,008), LR+ (33.43; 4.82-231.85), LR- (0.13; 0.08-0.23), accuracy (90.76%; 84.06-95.29%), and Matthews correlation coefficient (MCC) 0.82. Although considering only the probable SARS-CoV-2 infection (PCR-) cases, all the kits studied showed limited values. CONCLUSION: Our data demonstrate the excellent performance of LFA for the diagnoses of definite or probable SARS-CoV-2 infection. There was substantial heterogeneity in sensitivities of IgM and IgG antibodies among the different kits. LFA tests cannot replace molecular diagnostics but should be used as an additional screening tool.
Subject(s)
Antibodies, Viral/blood , COVID-19 Testing/methods , Serologic Tests/methods , Brazil/epidemiology , Case-Control Studies , Female , Humans , Immunoassay/methods , Immunoglobulin G/blood , Immunoglobulin M/blood , Male , Nucleic Acid Amplification Techniques , Pandemics , SARS-CoV-2 , Sensitivity and SpecificityABSTRACT
BACKGROUND: Respiratory infections are one of the leading causes of mortality, and comorbid conditions play a significant role in the severity and fatality of these infections. AIMS: We evaluated the Charlson Comorbidity Index (CCI) score and possible predictors of mortality in hospitalised patients with severe acute respiratory infection (SARI), aiming to test if the CCI is a valid in-hospital prognostic indicator. METHODS: Patients older than 14 years, hospitalised from 2010 to 2016 due to SARI by viral infection and who were submitted to respiratory virus testing were included. We assessed comorbidity retrospectively through chart review and calculated four variants of the CCI. RESULTS: Of the 291 patients assessed, 72.8% (n = 212) presented comorbidities, and 24% died (n = 70). The most recurrent comorbidities were chronic pulmonary disease (n = 76/212, 36%) and HIV (n = 50/212, 23.6%). The 1994 age-adjusted CCI predicted in-hospital mortality in SARI patients (P = 0.04), and HIV was associated with in-hospital mortality (P = 0.032). CONCLUSIONS: The comorbidity scores used to assess mortality risk in hospitalised patients with SARI displayed poor results, but HIV infection was considered a marker of severity. However, other factors should be considered in order to compose a score system that allows us to specifically assess the risk of mortality in patients with SARI.