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Deprecated: Implicit conversion from float 265.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 J+Clin+Virol 2020 ; 131 (ä): 104592 Nephropedia Template TP
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Performance of a qualitative rapid chromatographic immunoassay to diagnose COVID-19 in patients in a middle-income country #MMPMID32827898
Costa SF; Buss L; Espinoza EPS; Vieira JM Jr; de Oliveira da Silva LC; de Souza RM; Neto LP; Porto APM; Lazari C; Dos Santos VA; da Silva Duarte A; Nastri AC; da Costa Leite GF; Manuli E; de Oliveira MS; Zampelli DB; Pastore L Junior; Segurado AC; Levin AS; Sabino E
J Clin Virol 2020[Oct]; 131 (ä): 104592 PMID32827898show ga
OBJECTIVES: We evaluated a rapid chromatographic immunoassay (IgG/IgM antibodies) and an ELISA assay to diagnose COVID-19 in patient sat two Brazilian hospitals. METHODS: A total of 122 subjects with COVID-19 were included: 106 SARS-COV-2 RT-PCR-positive patients and 16 RT-PCR-negative patients with symptoms and chest computed tomography (CT) consistent with COVID-19. Ninety-six historical blood donation samples were used as controls. Demographic and clinical characteristics were retrieved from electronic records. Sensitivity and specificity were calculated, as were their 95% binomial confidence intervals using the Clopper-Pearson method. All analyses were performed in R version 3.6.3. RESULTS: The sensitivity of the chromatographic immunoassay in all RT-PCR-positive patients, irrespective of the timing of symptom onset, was 85.8% (95% binomial CI 77.7% to 91.9%). This increased with time after symptom onset, and at >14 days was 94.9% (85.9% to 98.9%). The specificity was 100% (96.4% to 100%). 15/16 (94%) RT- PCR-negative cases tested positive. The most frequent comorbidities were hypertension and diabetes mellitus and the most frequent symptoms were fever, cough, and dyspnea. All RT-PCR-negative patients had pneumonia. The most frequent thoracic CT findings were ground glass changes (n?=?11, 68%), which were bilateral in 9 (56%) patients, and diffuse reticulonodular infiltrates (n?=?5, 31%). CONCLUSIONS: The COVID-19 rapid chromatographic immunoassay evaluated in this study had a high sensitivity and specificity using plasma, particularly after 14 days from symptom onset. ELISA and qualitative rapid chromatographic immunoassays can be used for the diagnosis of RT-PCR-negative patients.